QA Specialist (Validation) Annex, Pharmaceutical, GMP -nr Crewe

QA SPECIALIST/QUALITY ASSURANCE SPECIALIST (ANNEX 11) - PHARMACEUTICALS/GMP

GBPCompetitive salary + 5% Bonus, attractive package

Quality, Pharmaceutical, GMP, V Model, Validation, ANNEX 11 EU GMP

QA SPECIALIST/QUALITY ASSURANCE SPECIALIST - a world leading pharmaceutical company is looking for an experienced QA SPECIALIST/QUALITY ASSURANCE SPECIALIST to join their team.

KEY RESPONSIBILITIES

• Works as part of the Quality Assurance team ensuring that cGMP is maintained.
• Interfaces with the project teams to provide quality expertise for all QA and Compliance topics relating to facility, utility and equipment design, qualification and validation, new product industrialisation.
• Provides Quality review and oversight at engineering project concept, design verification, commissioning and qualification activities including assisting in compliant resolution of issues.
• Participates in the review and approval of documentation to support site project needs.
• Ensures that activities related to project implementation meet cGMP requirements, performing self-inspection as required to ensure compliance of operations during project execution.
• Acts as the QA point person for systems/processes providing guidance/feedback on quality issues and performs timely reviews of documentation/investigations
• Works with all relevant departments to ensure timely closure of quality actions.
• Apply the principles of risk management in the execution of duties related to product quality, patient safety and efficacy.
• Actively contributes to continuous improvement initiatives by designing/implementing/improving quality systems and applying appropriate KPIs.
• Supports QA team in achieving team goals/targets

ESSENTIAL SKILLS/EXPERIENCE

• Degree in science or related discipline preferred plus demonstrable experience in a quality role within pharmaceutical industry, or equivalent.
• Excellent good knowledge of cGMP in a regulated environment
• Detailed knowledge of application of quality management systems.
• Competent knowledge of facility/utility/equipment/process/cleaning/computer systems qualification, new production introduction and commercial manufacture for pharmaceutical manufacturing facilities.
• Capable of troubleshooting/problem solving on issues associated with projects, process development etc.
• Good communication skills at organisation, team and individual levels.

I assure you that all applications will be treated in the strictest of confidence, and that your CV will not be sent to either this organisation or any other company without your express consent.

If you would like to apply for the above role, please forward your CV at your earliest convenience to Claire Jones at Experis