Senior Specialist - Quality Control

Role And Responsibilities

• Perform and implement method development/qualification/validation/verification for new product and method introduction, compendial updates.

• Keeps up to date on regulations/development of QC activities to ensure QC operations are in compliance to applicable regulatory and external agency regulations.

• Lead and perform laboratory investigation and deviation.

• Responsible to conduct effective training to ensure methods/knowledge are effectively transferred to routine testing team.

• Write/reviews change controls, events deviations, CAPA and GMP documents (e.g. SOP, protocols, reports, specification).

• Provides technical expertise and consultation to routine testing team on technical matters.

• Performs review of compendium updates timely and accurately.

• Perform periodic review of test methods to ensure compliance to latest compendium requirements.

• Ensure real time documentation, maintain data integrity and appropriate traceability.

• Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.

• Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.

• Subject-Matter-Expect (SME) audit frontier for assigned topics.

• Any other activities as and when assigned by the Superior.

Education & Experience

Education: Degree/Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biomedical Engineering, Biotechnology).

• Degree with minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

• Diploma with minimum 6 years of quality control experience in pharmaceutical manufacturing industry.

Knowledge & Skills

• Possess working knowledge of GMP in the pharmaceutical industry.

• A good team player with positive learning attitude.

• Able to work independently, shows initiative and able to work with all levels of staff.

• Excellent interpersonal and analytical skills, good verbal and written communication skills