QAQC Manager
Our client is a biopharmaceutical company. They are currently seeking for QAQC Manager.
The role of the QAQC Manager includes:
- Oversee the overall management of all Quality functions (Quality Assurance and Quality Control) and activities, ensuring compliance with regulatory and company requirements.
- Lead and collaborate with cross-functional teams through scheduled meetings and reviews to address quality issues, share updates, and drive improvements.
- Manage and analyze Quality budgets and CAPEX planning, ensuring cost efficiency and compliance, in coordination with Regulatory to align on budget plans and any changes.
- Define, monitor, and report on the performance of Quality operations, ensuring that all KPIs are achieved.
- Implement a culture of continuous improvement across GMP and international standards (ISO, FSSC), fostering excellence in quality and food safety systems.
- Liaise with Regulatory and Operations to ensure products are consistently manufactured according to quality standards, specifications, and regulatory requirements. Ensure compliance with GMP, ISO, FSSC, Halal, Kosher, and EHS policies and objectives.
- Oversee certification maintenance (ISO, FSSC, GMP, Halal, Kosher) in alignment with regulatory requirements. Review and maintain QMS documentation required for regulatory file submissions (e.g., active substance Drug Master File (DMF), ) or Certificate of Suitability to European Pharmacopeia (CEP) applications) to meet ICH Common Technical Dossier requirements.
- Ensure timely investigation and closure of non-conformances (deviations, OOS, complaints, recalls/returns) in collaboration with Regulatory to resolve quality / food safety issues, while leading multidisciplinary teams to address GMP process failures ensuring compliance and business continuity.
- Create / review / revise and or approve Quality Management System documentations (e.g., SOP, WI, equipment validation/qualification protocol/report, CAPAs, Change Control, OOS, Deviations Complaints, batch records, etc.) ensuring regulatory and standards requirements are met
- Collaborate with Regulatory in audit and inspection management, ensuring readiness, compliance to ISO, FSSC and GMP, and complete regulatory documentation, including supplier qualification, evaluation, and approval processes.
- Review and approve risk assessments in coordination with cross-functional teams to evaluate process or system / improvements changes that could impact regulatory, product quality and safety.
- Support Regulatory in fulfilling Management Representative responsibilities for international standards certifications (ISO, FSSC, Halal) and take over or delegated as acting Management Representative when required to ensure continuity.
- Lead recruitment, onboarding, training, mentoring and performance evaluation of Quality staff.
- Perform other duties and responsibilities as assigned by the General Manager from time to time.
Job Requirement:
- Bachelor's Degree in Chemistry, Pharmacy or Life/Pharmaceutical Science-related, or with MBA or Master's degree in science.
- At least more than 10 years related experience in a pharmaceutical plant, preferably GMP site, and with at least 5 years supervision experience in Quality (QA and QC laboratory) setting or managing a large group of people with varied experiences and competencies in a fast-paced and demanding environment.
- PIC/S or ICH GMP-oriented, including knowledge in food safety management system
- QEHS documents, SOPs, WIs, familiarity with applicable GMP regulatory (PICS Part II, ICH Guidelines (Q1 to Q12), and international standards (ISO 9001, ISO 22000, FSSC 22000, ISO 13485, Halal, Kosher) requirements
Interested candidates, please send your detailed resume stating Past Employments, including Reasons of Leaving, Last Drawn Salary for the most recent 2 positions (breakdown of basic salary, allowance, bonuses etc), Expected Basic Salary and availability.
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Posting Personnel: Win Hui
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