KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Operations Shift Leader will be varied however the key duties and responsibilities are as follows:
1. Ensure you and the personnel (internal and external) operating under your remit comply with all applicable regulatory standards, you will be responsible for closing out major deviation records and leading major quality investigations where applicable, including maintaining an ongoing dialogue with Quality Operations Management to ensure quality targets and objectives are able to meet business priorities.
2. Manage the Quality Management System including oversight of TrackWise records, Ensure customer complaints, deviations, CAPA actions and GDP incidents are completed and progressed in a timely manner on the Quality Management System and Identify and implement Quality System improvements where necessary.
3. Support the Production departments in handling deviation records, CAPA's and quality incidents.
Provide support and advice to internal departments to maintain and, where required, improve compliance to quality standards and processes by performing regular trend analysis of deviations, CAPA reviews and customer complaints to identify trends and suggest improvement strategies where required.
4. Coordinate the batch review process to ensure these are progressed in a timely manner and issues resolved prior to QP review, Assist and lead in internal and external audits. You will review performance and support in the recruitment process for new QA Officers.
To be successful in your application to this exciting opportunity as the QA Operations Shift Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific discipline.
2. Proven industry experience in QA Operations preferably in a Sterile bio-pharmaceutical environment.
3. A working knowledge and practical experience with GMP guidelines and risk analysis activities.
Key Words: Pharmaceuticals | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate | Aseptic | Biologics | Quality | Risk Analysis | QA Leader | Team Leader | Quality Manager | Deputy Quality Manager.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.