- Lead and supervise QA Specialists for QC lab support end to end activities.
- Review and approve laboratory investigations and QC deviations, change controls, QC testing specification, QC testing methods, procedures, operational instructions, deviations, stability reports etc. as and when required.
- Conduct training to increase knowledge and understanding of regulatory requirements, Company Standard, GMP requirements and ALCOA with the team and to QC team.
- Work closely with cross functional team to support them in QA oversight, supply demand planning and system troubleshooting.
- Develop the skills and capabilities of QA Specialists.
- Good knowledge and understanding cGMP, GAMP, validation principles, and applicable regulations related to validation principles.
- Accountable for team mentoring, lab investigation, analytical method validation/ transfer, QC procudere updates, internal and external audit program, planning and track team resources/ capacity utilization.
- Degree in Science/ Engineering or related science.
- Min 6 years of related experience in pharmaceutical manufacturing and quality operation.
- Min 2 years in a supervisory capacity.
- Related experience in GMP-regulated industries in QA Operations, QC Operations, QC Validation with Quality Systems knowledge such as Change Control, Deviation, CAPA and Documentation Management.
Tan Cheu Hoon, Fenny EA License No.: 02C3423 Personnel Registration No.: R22105896