QA Manager, QP Qualified.
Reporting to: Quality Director
- The QA Manager is responsible for managing, reviewing and developing GMP systems on site in accordance with cGMP principals.
- The position requires excellent inter-personal skills to assist in liaison with other departments within the site in order to support quality requirements.
- Responsible for review, investigation and close-out of product complaints in a timely manner.
- To publish and maintain the internal audit schedule. To ensure the execution of this calendar of events including reporting and close out of all issues.
- To administer and maintain the Change Control & Deviation systems in accordance with the relevant SOPs at Gerard Laboratories to ensure a timely close-out.
- Responsible for control of Approved Supplier Listings.
- Manage the Quality System for controlled drugs on site.
- Report Quality Defect Reports to the IMB and drive investigations for same.
- To ensure that up-to-date Technical Agreements are in place where Gerard Laboratories is the contract giver.
- To administer the SOP system for the entire facility.
- To coordinate and participate in third party audits (both customer and Regulatory) of Gerard Laboratories.
- Co-ordinate and develop GMP training on site.
- To ensure that the systems with a GMP impact are maintained as per written procedures.
- To ensure that good GMP standards are maintained at all times.
- To adhere to all company and legislative health, safety and environmental requirements.
- Any other duties as assigned by the Quality Director.
- Excellent interpersonal skills
- Minimum of a Bachelor Degree in Science or related pharmaceutical discipline.
- At least 6 years pharmaceutical quality experience ideally with previous QA management experience.
- Experience in a high volume environment.
- QP qualification.
- Previous experience in leading a Health Authority inspection would be an advantage.
- Proven track record with the IMB/FDA.
- A proven identifiable track record of success in a similar environment.
- Developed leadership skills that lead to results through people.
- Experience in managing change and seeking continuous improvements.
- Have an understanding of, or exposure to Operational Excellence principles