Total 4 Senior Executive chemist job vacancies in Quality Assurance / Control category

Primary Goals/Objectives:

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met.

Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.

Major Responsibilities:

• Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures.
• Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath and etc.
• Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management.
• Review lot release data, identify testing discrepancies and participate in laboratory investigations.
• Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
• To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
• To carry out completion and review of GMP Documentation of data sheets or LIMS software.
• To carry out QC sample receipt, assay and release procedures.
• Support Audit preparation and any audit related activity
• Reading and understanding the test procedure and the requirements per USP, JP and EP.

Requirements:

• min. Bachelor Degree in Biochemistry and above
• Possess 2-3 years of prior lab analyst experience in bio-chemistry related functions
• Able to do 12 hour rotating day and night shift

Interested candidates, please forward your resume to jalenetan@recruitexpress.com.sg

Consultant: Jalene Tan (R26160390)
Recruit Express Pte Ltd (99C4599)

Primary Goals/Objectives:

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met.

Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.

Major Responsibilities:

• Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures.
• Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath and etc.
• Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management.
• Review lot release data, identify testing discrepancies and participate in laboratory investigations.
• Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
• To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
• To carry out completion and review of GMP Documentation of data sheets or LIMS software.
• To carry out QC sample receipt, assay and release procedures.
• Support Audit preparation and any audit related activity
• Reading and understanding the test procedure and the requirements per USP, JP and EP.

Requirements:

• min. Bachelor Degree in Biochemistry and above
• Possess 2-3 years of prior lab analyst experience in bio-chemistry related functions
• Able to do 12 hour rotating day and night shift

Interested candidates, please forward your resume to jalenetan@recruitexpress.com.sg

Consultant: Jalene Tan (R26160390)
Recruit Express Pte Ltd (99C4599)

Key Responsibilities

1.     To ensure that all manufactured products conform with specified standards before products are released / sold to customers.

2.     To supervise and ensure smooth QC routine raw material &work-in-progress testing.

3.    Issuing COA, COC or any other documentations upon customer's request.

4.    Collecting data and study trend analysis for improving current product application performance.

5.    Participate in assessing and qualifying new raw materials for potential use.

6.     Work with procurement to ensure that raw materials purchased are within specifications.

7.     Maintain and manage retention samples keeping &disposal.

8.     Investigate customer’s complaint, correction actions and preventive actions taken are documented.

9.     Proper isolation and disposition of non-conformance materials and products.

10. Involves in product development initiatives, lab trial sample preparation, performs formulation adjustments, conducts stability monitoring and maintain proper record and documentation.

11.  To assist the Company’s Workplace Safety and Health committee.

12.  Compile and analyze customer’s complaints to establish trends and alert Management / Sales Customer Service / Production / Procurement for concerted effort to pre-empt and eradicate issues.

13. Knowledge of ISO management systems and experience with Halal certification applications or renewals would be an advantage.

14.  Prepare technical reports for management information.

Other Duties:

The duties listed are not exhaustive and may be varied from time to time as dictated by the changing needs of the organisation.

The post holder will be expected to undertake other duties as appropriate and as requested by his/her manager.

Responsibilities : 

• Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements. 
• Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements. 
• Use Imex "ways of working" for day-to-day operations, problem solving, escalation and continuous improvements. 
• Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed. 
• Assess impact to products based on compendial monograph changes/updates/introduction. 
• Support regulatory submissions and queries for post transfer activity. 
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory. 
• Conduct Laboratory investigations and propose CAPA for the identified root cause. 
• Train colleagues in hands on training of instruments and methods written 
• Perform review and approval of test results. 
• Able to write position paper, protocols, reports and test procedures. 
• Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods. 
• Conduct trainings for fellow QC colleagues on new methods in the laboratory. 
• Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated. 
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
• Perform cleaning method development and validation. 
• Ensure following the site GDP practice on documentation and preparation of document. 
• Method verification in accordance to site or pharmacopeia standards and according to schedule. 
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.

Job Skill Requirements:

• Min. Degree with 5 years of QC Experience in pharmaceutical or related industries
• Demonstrated technical skills in method transfer, validation, verification and testing.
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures and governmental regulations
• Experienced in Method Transfer, Method Validation and Method Verification activity.
• Knowledge of cGMPs and ALCOA principles.
• Laboratory work experience with analytical HPLC, GC, FTIR, UV, KF and other lab equipment.
• Experienced in leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics