Quality Assurance Manager
5 days ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd.
Key Responsibilities:
- Support the Head of QA & RA in implementing and maintaining the Quality Management System in accordance with GMP and GDP Guidelines, ISO 9001, and ISO 13485 standards.
- Ensure the initial and ongoing validation of systems and equipment used for temperature-controlled product storage and transportation.
- Participate in Quality System Management Reviews, including meeting inputs, attendance, and presentation.
- Host and support regulatory, ISO, and client audits, as well as supplier audits, internal audits, and self-inspections.
- Ensure effective control of documentation within the Quality Management System, in line with procedures for document control and physical/electronic records.
- Collaborate with the Responsible Person to perform pharmaceutical recall operations.
- Maintain licenses and certifications, ensuring compliance with EU GMP and GDP guidelines, Human Medicines Regulations, and Veterinary Medicines Regulations.
- Focus on licensable activities, record accuracy, compliance with SOPs, and quality of handling and storage equipment and facilities.
- Advise on regulatory requirements for the medicinal product supply chain, including classification, import/export requirements, and EU GMP and GDP guidelines.
- Knowledge of electronic Quality Management Systems and Warehouse Management Systems is an advantage.
Qualifications and Experience:
- Excellent knowledge of GDP regulations.
- Experience with ISO 9001 and/or ISO 13485 standards is an advantage.
- Required 3 years of experience in companies such as manufacturers, laboratories, or distributors of pharmaceutical products, food, and feed.
- Bachelor's Degree.
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