Quality Assurance Manager / Responsible Person

QUALITY ASSURANCE MANAGER & RESPONSIBLE PERSON - 5 DAYS A WEEK ONSITE

Key Responsibilities:

• Supporting the Head of QA & RA, Responsible Person(s) and Qualified Person(s) with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP Guidelines and GPhC, ISO 9001 and ISO 13485 standards.
• Ensuring 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.
• Participating in Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings and the management of the meeting outputs.
• Hosting and supporting Regulatory, ISO and Client audits and conducting Supplier audits, internal audits, and self-inspections, including the preparation of responses and CAPA plans.
• Ensuring the effective control of all documentation within the Quality Management System, in line with procedures for the control of documents, physical and electronic records.
• Collaborating with the RP(s) to urgently and accurately perform all operations required during a pharmaceutical recall.
• The Responsible Person (RP) is named all relevant licences and registrations required for the Licence Holder’s operations, including the WDA(H&V), MIA, Controlled Drugs licences.
• The RP must 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, Misuse of Drugs Act and Misuse of Drugs Regulations, and all associated applicable regulations.
• The RP must focus on the management of licensable activities, the accuracy and quality of records, compliance with standard operating procedures and GMDP, the quality of handling and storage equipment and facilities, and the standards achieved.
• Advising on the regulatory requirements of the medicinal product supply chain, including medicinal product classification, requirements for import and export of medicinal products.
• Any other specific RP responsibilities as described in the current 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 manufacturer / laboratories / distributors of pharmaceutical products, food, and feed.
• Bachelor's Degree