Job Description

Jobscope:

• Head of the quality department (QA, QC & Laboratory)
• Establish & monitor Quality Management System (QMS) for compliance of current GMP, PIC/s, ASEAN guidelines, USFDA, pharmacopeia & other regulatory requirements.
• Ensure all documents of QMS are up-to-date, trained, distributed, implemented & continuously improved.
• Manage change control & impact assessment for all changes in QMS.
• Manage all deviations, conduct impact assessment, investigations & close-out with CAPA.
• Work with cross-functional teams to make risked based decision & resolve operational quality issues.
• Ensure all verification, calibration, qualification & validation are conducted on production machines & analytical instruments.
• Liaise with suppliers for quality issues, conduct supplier audit & assess supplier quality performance.
• Evaluate & approve of new materials, suppliers, contractors & outsourced activities.
• Lead internal audit, external audit & ensure the non-conformities are closed-out.
• Present Product Quality Review & Management Review to management team.
• Assist management team in define & implement Quality Policy & Objectives at all levels in company.
• Liaise with subsidiaries for change control, quality issue & corporate quality standards.
• Conduct GMP Training & ensure other QMS trainings are conducted accordingly.
• Ensure Good Documentation Practices for documents retention, traceability & retrievability.
• Manage recall, return, customer complaint, counterfeit & conduct mock recall.
• Review Batch Process Records & approve to release incoming materials, Work-In-Progress & finished products for the absence of QC Manager / QC Specialist.
• Reject materials & suspend production when quality is affected.
• Supervision of laboratory activities for GLP compliance & productivity review.
• Ensure work safety & healthy environment in quality department.

Requirements:

• Minimum bachelor\xe2\x80\x99s degree in Pharmaceutical, Bioscience, Chemical or related courses.
• Minimum 5 years of working experience in GMP environment.
• Working knowledge of GLP, GMP & ISO.
• Hands-on experience in equipment qualification & validation will be an advantage.
• Ability to lead a team of 6-7 headcounts

We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239

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