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Quality Assurance Manager
2 months ago
Pharma Partners Recruitment Ltd is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the implementation and maintenance of our Quality Management System in accordance with GMP and GDP guidelines.
Key Responsibilities:- Quality System Management: Collaborate with the Head of QA & RA to implement and maintain the Quality Management System, ensuring compliance with GMP and GDP guidelines.
- 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.
- Regulatory Compliance: Participate in Quality System Management Reviews, including the preparation of meeting inputs, attendance, and presentation at meetings, and the management of meeting outputs.
- Audit and Inspection: 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 RP to urgently and accurately perform all operations required during a pharmaceutical recall.
- Qualifications: Bachelor's Degree
- Experience: 3 years of experience in companies such as manufacturers, laboratories, or distributors of pharmaceutical products, food, and feed.
- Skills: Excellent knowledge of GDP regulations, experience with ISO 9001 and/or ISO 13485 standards is an advantage.
