QAQC Manager

QAQC Manager

Ourclient is a biopharmaceutical company. They arecurrently seeking for QAQC Manager.

The role ofthe QAQC Manager includes:

· Directand oversee the full spectrum of Quality Assurance and Quality Controloperations, ensuring that all activities adhere to applicable regulatoryframeworks, industry standards and internal quality policies.

· Develop,monitor and manage departmental budgets, including operating expenditure andCAPEX requirements, with a focus on resource optimization and cost effectiveness.Work closely with the Regulatory team on budget planning, forecasting andexpenditure adjustments.

· Partnerwith Regulatory Affairs and Operations to maintain consistent product qualitythroughout the manufacturing process. Ensure operational practices comply withrelevant GMP, ISO, FSSC 22000, Halal, Kosher and EHS standards.

· Overseethe implementation, renewal and ongoing maintenance of quality certificationsand accreditations. Ensure the adequacy of quality-related technicaldocumentation supporting regulatory submissions, including Drug Master File(DMF) and Certificate of Suitability (CEP) applications, in accordance with ICHCommon Technical Document (CTD) guidelines.

· Drivethe effective management and resolution of quality incidents, includingdeviations, out-of-specification results, customer complaints, product recallsand returns. Coordinate cross-functional investigations and corrective measuresto address GMP-related deficiencies, minimize operational disruptions andsafeguard product compliance.

· Provideoversight and approval of Quality Management System (QMS) documents, includingstandard operating procedures, work instructions, validation and qualificationprotocols, CAPA records, change management documentation, investigation reportsand manufacturing batch records.

· Workalongside Regulatory Affairs to coordinate external audits, regulatoryinspections and certification assessments. Maintain audit preparedness andensure compliance with applicable quality standards, while overseeing supplierassessment, qualification and approval activities.

· Assistthe Regulatory team in discharging Management Representative duties relating tointernational quality certifications, including ISO, FSSC and Halal. Assumedelegated responsibilities as Acting Management Representative whenevernecessary to maintain effective system governance.

· Managethe Quality department's human resources, covering manpower planning,recruitment, staff development, technical training, coaching and performanceassessments to build a competent and effective team.

· Undertakeadditional assignments and management-related responsibilities as directed bythe General Manager.

JobRequirement:

• 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 sendyour detailed resume stating Past Employments, including Reasons of Leaving, LastDrawn Salary for the most recent 2 positions (breakdown of basic salary,allowance, bonuses etc), Expected Basic Salary and availability.

WE REGRET TOINFORM THAT ONLY SHORTLISTED CANDIDATES WILL BE NOTIFIED

Manfield Employment Services Pte Ltd (Lic. No: 95C2823)
Posting Personnel: Win Hui
EA Personnel Reg No.: R23115634

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