Responsible in managing the Biological laboratory activities to ensure timely availability and accuracy of results.
Review and approve all required biochemistry/microbiological testing’s for utilities, raw materials, environmental, manufacturing processes and product; ensure that the tests are analyzed in accordance with corporate, regulatory and external agency regulations.
Enforce all laboratory policies and practices and ensure that all in-use procedures are current and compliant.
Maintain all safety and security policies and procedures.
Support equipment/software/method validation and performed revalidation when necessary.
Provide support and technical support expertise.
Participate in investigation of non-conformities (deviations and exceptions)
Identify and report problems in QC. Solve and implement corrective actions
Provide leadership and guidance to the team.
Ensure continuous improvement of the QC Operations.
Proposal of CAPA for any issues/deviation/exceptions
Proposal of QC improvements projects and strategies.
Min. Degree in Life Sciences, Biotechnology, Biochemistry, Microbiology or equivalent with more than 5 years of relevant experience, preferably in the pharmaceutical industry with supervisory experience.
Good communication and proven leadership skills
Hands on experience in Biochemistry/Microbiological testing
Experience in Laboratory equipment qualification, Aseptic techniques Knowledge of cGLP and cGMP
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | Fiona Koh | Registration No: R1109239