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Quality Assurance and Compliance Manager
2 months ago
Job Title: Quality Assurance and Compliance Manager
Company: Pharma Partners Recruitment Ltd
Job Type: Full-time
Location: Onsite, 5 days a week
About the Role:
We are seeking an experienced Quality Assurance and Compliance Manager to join our team. The successful candidate will be responsible for ensuring the implementation and maintenance of our Quality Management System in accordance with GMP and GDP guidelines, ISO 9001 and ISO 13485 standards.
Key Responsibilities:
- Support the Head of QA and RA: Collaborate with the Head of QA and RA to ensure the effective control of all documentation within the Quality Management System, in line with procedures for the control of documents, physical and electronic records.
- Validation and Verification: Ensure the initial and ongoing validation of all systems and equipment used to monitor and maintain the storage and transportation of products requiring temperature-controlled conditions.
- Quality System Management Reviews: Participate in Quality System Management Reviews, including the preparation of meeting inputs, attendance, and presentation at meetings, and the management of meeting outputs.
- Regulatory and Client Audits: Host and support Regulatory, ISO, and Client audits, and conduct Supplier audits, internal audits, and self-inspections, including the preparation of responses and CAPA plans.
- Documentation Control: Ensure the effective control of all documentation within the Quality Management System, in line with procedures for the control of documents, physical and electronic records.
- Recall and Compliance: Collaborate with the Responsible Person(s) to urgently and accurately perform all operations required during a pharmaceutical recall.
- Licenses and Certifications: Maintain the licenses and certifications of the company and ensure that PSDL can demonstrate compliance to current EU GMP and GDP guidelines, Human Medicines Regulations, and Veterinary Medicines Regulations.
- Regulatory Requirements: Advise on the regulatory requirements of the medicinal product supply chain, including medicinal product classification, requirements for import and export of medicinal products.
- Additional Responsibilities: Perform any other specific RP responsibilities as described in the current EU GMP and GDP guidelines.
Requirements:
- Experience: 3 years of experience in companies such as manufacturers, laboratories, or distributors of pharmaceutical products, food, and feed.
- Qualifications: Bachelor's Degree
- Skills: Excellent knowledge of GDP regulations, experience with ISO 9001 and/or ISO 13485 standards, and knowledge of electronic Quality Management Systems and Warehouse Management Systems.
