Responsibilites:

• 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.

Requirements

• 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

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