Quality Assurance Head
4 days ago
We are seeking an experienced Quality Assurance & Quality Control (QA/QC) Division Head to lead and oversee quality operations across all aspects of manufacturing, packaging, testing, and compliance. This role is responsible for ensuring that all raw materials, packaging components, in-process and finished products conform to established standards, regulatory requirements, and client specifications.
The QA/QC Head will direct multiple teams engaged in Quality Assurance, Quality Control, Validation, Compliance, and Regulatory activities, while ensuring adherence to cGMP, Good Laboratory Practices, and international quality standards.
Key Responsibilities
- Lead and manage QA/QC teams across multiple sections, including Packaging Inspection, Raw Materials Testing, Microbiological Assay, Physical & Chemical Testing, Stability Studies, Technical Services, Validation, and Regulatory.
- Approve and oversee technical and quality system documents (e.g., manufacturing orders, validation protocols, deviation reports, risk assessments, change control, complaints, CAPA, and SOPs).
- Ensure compliance with FDA, PIC/S, ISO 9001:2015, and other regulatory requirements.
- Conduct audits of suppliers, packaging material vendors, and internal processes.
- Act as lead auditor and approver for suppliers, validation documents, and product release for domestic and international markets.
- Lead investigations, product recalls, and complaint handling, ensuring timely client communication and resolution.
- Provide training, coaching, and performance evaluation for managers and staff under the QA/QC division.
- Oversee GMP training programs, environmental monitoring, equipment validation, and preventive maintenance schedules.
- Collaborate with cross-functional teams including Production, Engineering, Supply Chain, Technical Services, and Accounts Management to drive quality improvements.
- Maintain liaison with FDA and external stakeholders regarding technical and regulatory matters.
Qualifications
- Bachelor's Degree in Chemistry, Chemical Technology, Chemical Engineering, Pharmacy, or Industrial Pharmacy (professional license preferred).
- Minimum of 6 years of managerial experience in QA/QC within the pharmaceutical, cosmetics, veterinary, or food manufacturing industry.
- Strong expertise in GMP, laboratory practices, pharmaceutical manufacturing, packaging technology, and regulatory compliance.
- Hands-on knowledge of validation, risk management, deviation handling, CAPA management, supplier qualification, complaint management, and stability studies.
- Proven leadership skills with the ability to supervise multiple managers and technical staff.
- Strong decision-making, analytical, and problem-solving skills.
- Proficient in project management, report preparation, and technical documentation.
- Computer literate; familiarity with ISO quality systems is an advantage.
Job Types: Full-time, Permanent
Pay: Php250, Php260,000.00 per month
Benefits:
- Company car
- Company Christmas gift
- Company events
- Health insurance
- Life insurance
- Paid training
- Pay raise
Work Location: In person
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