Senior Quality Validation Specialist (Contract)
Full-time
Senior Executive
2 months ago
Senior Quality Validation Specialist(6 month contract)About the Company:Our client is a US healthcare and a leading global biopharmaceutical company......
Senior Quality Validation Specialist
(6 month contract)
About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission
The essential functions include but are not limited to:
- The incumbent will be part of Digital & Data Quality (DDQ) team for Operational Support, Lifecycle Management (LCM), and Capital projects, collectively known as Projects thereafter, will be responsible for the quality aspects of Good Manufacturing Practice (GMP) computerized systems/equipment and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
- This includes involvement in all quality-related activities for computerized systems which are required by the client Manufacturing site Quality Manual or with potential for impact on product quality, patient safety or data integrity.
- The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
- The incumbent must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
Primary Responsibilities:
As part of the DDQ team and reporting to the Associate Director of DDQ or higher, the incumbent will be responsible for:
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes. This includes:
- Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
- Interfacing with the Manufacturing site DMO (Digital Manufacturing Organization) and other internal & external entities to align GMP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives
- Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
- Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
- Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
- Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
- Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
- Driving resolution of regulatory non-conformance for GMP computerized systems.
- Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
- Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
- Representing DDQ management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
- Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.
Requirements:
- Diploma or bachelor’s degree in chemical engineering or any other relevant engineering field
- Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations in GMP environment.
- At least 5 years of experience in regulated pharmaceutical manufacturing industry.
- At least 3 years of experience in delivering validated Lab Systems Qualification experiences solutions or an application support role in a regulated environment.
- Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
- Demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.
- Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
Reg No: R22104540
EA License no: 94C3609
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