Total 6 job vacancies by Amaris Act Pte. Ltd.

ABOUT THE JOB

• Support and execute technology transfer for drug substance manufacturing
• Drive scale-up activities from lab to commercial production
• Collaborate with cross-functional teams to ensure smooth implementation
• Develop and optimize processes including purification, homogenisation, and cleaning processes for routine operations
• Provide technical guidance to site teams
• Lead and support validation activities including cleaning validation, water mixing validation, and risk assessments (e.g. extractables & leachables – E&L)
• Ensure compliance with GMP and regulatory standards
• Prepare and review validation protocols, reports, and technical documentation
• Support integration of single-use systems and new manufacturing equipment

ABOUT YOU

• Academic background: degree in engineering, life sciences, or related field
• Experience in commercial-scale GMP manufacturing (biologics drug substance)
• Strong background in tech transfer and process validation
• Hands-on experience with chromatography and filtration processes
• Proven experience in cleaning validation and water mixing validation
• Strong understanding of both manufacturing and quality perspectives
• Experience in lab-to-commercial scale-up
• Fluent English. Additional languages are a plus.
• You demonstrate strong problem-solving and stakeholder collaboration skills

WHY AMARIS?

• An international community bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Job Summary 

We are looking for a QC Equipment Qualification Specialist to support qualification, lifecycle management, and decommissioning activities for Quality Control laboratory equipment within a GMP-regulated manufacturing environment. 

This role will support the execution and coordination of qualification activities, change control, validation documentation, and equipment lifecycle compliance. The successful candidate will work closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure laboratory equipment is qualified, documented, and maintained in accordance with site and regulatory requirements. 

Your Missions 

• Support qualification activities for QC laboratory equipment in accordance with GMP, validation lifecycle, and change control requirements. 

• Coordinate and execute equipment qualification activities including IQ, OQ, and PQ where applicable. 

• Support decommissioning activities for QC laboratory equipment following approved procedures and compliance requirements. 

• Assist in defining project plans, timelines, documentation needs, and coordination activities for qualification and decommissioning projects. 

• Prepare, review, and maintain qualification protocols, reports, SOPs, risk assessments, and training materials. 

• Support deviations, investigations, CAPA, and change control activities related to laboratory equipment and qualification processes. 

• Review qualification and validation documentation to ensure completeness, traceability, and compliance with GMP and site quality expectations. 

• Collaborate with QC, Validation, Engineering, Quality Assurance, and vendors to ensure timely execution of project activities. 

• Ensure proper documentation practices, data integrity, and compliance standards are followed for laboratory equipment systems. 

• Support equipment integration activities where applicable, such as LabX connectivity or related laboratory data systems. 

• Track action items, project milestones, risks, and implementation progress to support delivery within agreed timelines. 

Your Profile 

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related discipline. 

• 5–8 years of experience in qualification, validation, commissioning, or lifecycle management within GMP-regulated manufacturing or laboratory environments. 

• Hands-on exposure to QC laboratory equipment qualification and validation activities. 

• Good understanding of GMP documentation, validation lifecycle, change control, deviation, and CAPA processes. 

• Experience preparing or reviewing qualification protocols, reports, SOPs, risk assessments, or validation documentation. 

• Familiarity with analytical or laboratory equipment such as continuous flow analysers, nitrogen analysers, TOC systems, gas generators, analytical balances, microbalances, or similar laboratory instrumentation would be an advantage. 

• Exposure to laboratory system integration platforms such as LabX or related laboratory software systems is preferred. 

• Strong documentation, coordination, and stakeholder communication skills. 

• Detail-oriented, organized, and comfortable working within structured quality and compliance environments. 

• Able to manage multiple tasks and timelines within project-based environments. 

What We Offer 

• An international community bringing together 110+ different nationalities. 

• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities. 

• A robust training system with our internal Academy and 250+ available modules. 

• A vibrant workplace that frequently gathers for internal events, afterworks, and team buildings. 

• Strong commitments to CSR, notably through participation in our WeCare Together program. 

Job Summary 

We are looking for a Senior QC Equipment Qualification Specialist / Lead to manage qualification, lifecycle management, and decommissioning activities for Quality Control laboratory equipment within a GMP-regulated manufacturing environment. 

This role will take ownership of qualification strategy, project execution, documentation compliance, risk management, and stakeholder coordination across laboratory equipment lifecycle activities. The successful candidate will act as a senior technical contributor and coordination lead, working closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure equipment systems remain compliant, audit-ready, and aligned with site and regulatory expectations. 

Your Missions 

• Lead qualification activities for QC laboratory equipment in accordance with GMP, validation lifecycle, and site change control requirements. 

• Own and manage equipment qualification lifecycle activities including IQ, OQ, PQ, requalification, periodic review, and decommissioning where applicable. 

• Define project strategies, implementation plans, timelines, risk mitigation approaches, and resource coordination for qualification and decommissioning projects. 

• Lead decommissioning activities for QC laboratory equipment in accordance with approved procedures, compliance requirements, and site quality standards. 

• Author, review, and approve qualification protocols, reports, SOPs, risk assessments, traceability matrices, and training materials. 

• Provide technical guidance on deviations, investigations, CAPA, change control, and impact assessments related to laboratory equipment and qualification processes. 

• Review validation and qualification documentation to ensure compliance with GMP, GDP, data integrity, and regulatory expectations. 

• Partner closely with QC, Validation, Engineering, Quality Assurance, IT, and external vendors to drive timely and compliant project execution. 

• Ensure documentation traceability, inspection readiness, and lifecycle compliance for laboratory equipment systems. 

• Support and coordinate laboratory equipment integration activities where applicable, including LabX connectivity or related laboratory data systems. 

• Monitor project milestones, risks, dependencies, action items, and implementation progress to ensure delivery within timelines. 

• Act as a subject matter expert for QC laboratory equipment qualification, lifecycle management, and compliance-related discussions. 

Your Profile 

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related discipline. 

• 10+ years of experience in equipment qualification, validation, commissioning, lifecycle management, or compliance within GMP-regulated manufacturing or laboratory environments. 

• Strong experience managing QC laboratory equipment qualification and validation activities. 

• Solid understanding of GMP, GDP, data integrity, validation lifecycle, change control, deviation, CAPA, risk assessment, and audit readiness requirements. 

• Proven experience authoring, reviewing, and leading qualification protocols, reports, SOPs, risk assessments, validation plans, and related compliance documentation. 

• Experience managing qualification or decommissioning projects involving multiple stakeholders, vendors, and timelines. 

• Familiarity with analytical or laboratory equipment such as continuous flow analysers, nitrogen analysers, TOC systems, gas generators, analytical balances, microbalances, or similar laboratory instrumentation would be an advantage. 

• Experience with laboratory system integration platforms such as LabX or related laboratory software systems is preferred. 

• Strong stakeholder management, project coordination, documentation review, and technical problem-solving skills. 

• Able to work independently, guide project teams, and manage competing priorities in a structured GMP environment. 

• Detail-oriented, compliance-focused, and capable of supporting inspection or audit readiness activities. 

What We Offer 

• An international community bringing together 110+ different nationalities. 

• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities. 

• A robust training system with our internal Academy and 250+ available modules. 

• A vibrant workplace that frequently gathers for internal events, afterworks, and team buildings. 

• Strong commitments to CSR, notably through participation in our WeCare Together program. 

Job Summary

We are looking for a QC Equipment Qualification to support qualification, lifecycle management, and decommissioning activities for Quality Control (QC) laboratory equipment within a GMP-regulated medical manufacturing environment.

This role will be responsible for managing qualification activities, supporting change control and validation processes, and ensuring equipment compliance throughout the equipment lifecycle. The successful candidate will work closely with Quality, Validation, Engineering, and Laboratory teams to support operational readiness, documentation compliance, and project execution for laboratory equipment systems.

Your missions

• Manage qualification activities for QC laboratory equipment in accordance with GMP validation and change control processes
• Support and manage decommissioning activities for QC equipment following approved procedures and compliance requirements
• Define project strategies, implementation plans, timelines, and coordination activities for qualification and decommissioning projects
• Coordinate qualification lifecycle activities including installation, operational, and performance qualification (IQ/OQ/PQ) where applicable
• Support deviations, investigations, CAPA, and change control activities related to laboratory equipment and qualification processes
• Author and maintain SOPs, qualification protocols, reports, risk assessments, and training materials
• Review qualification and validation documentation to ensure compliance with GMP and site quality requirements
• Collaborate closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure timely project execution
• Ensure proper documentation, traceability, and data integrity practices for laboratory equipment systems
• Support equipment integration activities where applicable (e.g., LabX connectivity and laboratory data systems)
• Track project milestones, risks, action items, and implementation progress to ensure delivery within timelines

Your profile

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or related disciplines
• Minimum 2-3 years of experience in supporting qualification, validation, commissioning, or lifecycle management activities within GMP-regulated manufacturing environments
• Exposure to QC laboratory equipment qualification and validation processes
• Understanding of GMP documentation, validation lifecycle, change control, deviation, and CAPA processes
• Experience authoring qualification protocols, reports, SOPs, or validation documentation
• Familiarity with analytical or laboratory equipment such as continuous flow analysers, nitrogen analysers, TOC systems, gas generators, analytical balances, microbalances, or similar laboratory instrumentation would be an advantage
• Exposure to laboratory system integration platforms such as LabX or related laboratory software systems is preferred
• Strong coordination, documentation, and stakeholder management skills
• Detail-oriented with the ability to work within structured quality and compliance environments
• Able to manage multiple activities and timelines within project-based environments

What we offer

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• Strong commitments to CSR, notably through participation in our WeCare Together program

ABOUT THE JOB

• Conduct analytical testing and ensure accurate documentation for: API / drug substance / drug product / finished product samples, complaint samples, stability samples, and packaging material samples
• Handle sample storage and laboratory documentation in accordance with cGxP standards
• Guarantee compliance with data integrity principles
• Perform maintenance, calibration, and qualification of analytical equipment
• Support stability activities, including testing and documentation (when not centralized)
• Strictly adhere to HSE guidelines and proactively identify and report risks
• Maintain a constant state of inspection readiness
• Contribute to continuous improvement initiatives and process optimization
• Complete mandatory training activities within the defined timelines
• Work according to a defined shift rotation system to ensure operational continuity

ABOUT YOU

• 1 to 3 years of experience in a pharmaceutical laboratory environment (Quality Control, Quality Assurance, or Production preferred)
• Experience with aseptic techniques is considered an advantage
• Completed apprenticeship as a laboratory assistant or equivalent qualification
• Strong teamwork skills and a results-driven mindset
• Knowledge of GMP, GxP standards, TQM principles, and laboratory best practices
• Familiarity with QC testing, sampling procedures, and laboratory equipment
• Structured, rigorous, and able to work efficiently in a regulated environment
• Analytical, resilient, and committed to operational excellence
• Comfortable working in a shift-based organization

ABOUT THE JOB

Brand positioning

• Break down the brand strategy locally considering the local culture, local budget and the international strategy.
• Build and promote a client advocacy (success stories, testimonies, logos, partnership).
• Define action plan to improve the E-reputation.
• Developing his/her professional network by maintaining relationships with all the stakeholders and creating new ones (candidate, partners, client, competition…)
• Represent the company externally (lectures, schools, …).

Business prospection

• Control and coach in the elaboration of commercial and technical proposals, including responses to Tenders.
• Control and coach in the negotiation of the framework agreements.
• Handling C-level customers relationships, anticipate the customers’ needs and environments and guide them in their strategic evolution.
• Identify potential clients and assess their business requirements
• Negotiate big deals ensuring the respect of the bid processes.
• Promote cross-selling over the different brands of the Group.

Business strategy

• Creating, adapting, and deploying a yearly business plan.
• Define consistent and long-term business strategy based on a rigorous data analysis, market trends and the Group strategy.
• Defining an Account Strategy on their scope and ensure all key accounts have a business plan.
• Defining offers and delivery models in line with the market needs, to reach the business plan.
• Map and understand competition (meet collaborators in ITW, meet directors/pairs…)

Certifications & knowledge management

• Communicate, embody, and implement group & entity decisions (policies, processes, guidelines, projects) to the teams aiming at conformity.
• Identify and rate risks & non-compliant areas and improve them.
• Introduce the entity and its strategy in audit context.
• Nominate people to be audited.
• Spot topics to be audited, based on the audit focus.

Finance

• Ensure compliance of costs in the system.
• Monitor the financial business plan and spot gaps with the reality.
• Spot, animate and coordinate actions to improve the financial performance (increase ratings, lower Days Sales Outstanding, invoices paid, …).
• Support the implementation of the periodic Financial Calendar & Reporting (P&L, FC, check and validations).
• Translate the business strategy in a financial business plan.

Human Resources

• Analyse the offboarding reasons and intervene in the leaves to retain people.
• Arbitrate in HR litigations and conflicts.
• Coach the teams around yearly appraisals and validate individual action plan (Career Committee Meeting).
• Define and implement a local C&B strategy according to the brand C&B guidelines.
• Define and implement a training strategy with HR local team.
• Define and implement an HR strategy (People Review) with HR local team.
• Define, monitor and ensure the respect of a yearly wages budget.
• Ensure the HR brand strategy is broken down locally (D&I, turnover, etc.).
• Ensuring the proper onboarding process.
• Follow-up the key people succession plans and talents action plans.
• Monitor and improve people satisfaction.

Legal

• Coach the team to raise their awareness in the commercial legal standards importance, and meet the minimum required strandards.
• Ensure compliance in HR & commercial contracts (clauses negotiation…).

Recruitment

• Define a hiring strategy (direct/on project, internal/external…) and a recruitment plan according to the financial and business plan (number of people and needed expertise).
• Monitor the recruitment indicators based on the recruitment plan.
• Find locally candidates thanks to a schools calendar.

Team Management

• Coach and support people for local & group audiences.
• Communicate and embody the group & entity strategy and results to the teams.
• Create and animate a strategy to federate people through shared moments (afterworks, challenges …) and a smart working environment.
• Follow-up the performance of the team (top performance/potential people, and close monitored people) and take actions and decisions accordingly.
• Involve the corporate business partners and topics in the strategy.

ABOUT YOU

Soft skills and requirements

• Bachelor's degree from top business or engineering schools (Master's degree or MBA preferred)
• Minimum of 8 years experience with 5+ years in the consulting industry and leadership role
• Strong knowledge in the one of the following fields: Pharmaceutical industry/Engineering/IT
• Fluent in English to liaise with different stakeholders in Europe and Asia
• Experience in doing business in Asia and managing large multicultural teams
• Experience with budget and business plan development
• In-depth knowledge of diverse business functions and principles (e.g. finance, Customer service, management, coaching etc.)
• Ability to negotiate with internal & external Stakeholders
• Ability to streamline and implement new structures & policies for new opening brands or countries.
• Ability to analyze processes and assess the risks (HR, Financial)
• Experience working in an ISO environment and in consulting topics
• Ability to identify weak spots in a process to improve efficiency (policies, procedures)
• Great planning and project management skills
• Results-driven and ability to communicate
• Ability to work in a fast-growing environment