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

Senior Specialist - Quality Control