Quality Systems Specialist – 2 year Fixed Term Contract

We are currently looking to recruit a quality systems specialist with experience in pharmaceutical manufacturing to come and join us on a fixed term contract. You will be working in our finished dose business unit supporting a major project. Ideally we are looking for candidates that have at least 2 years’ experience working in pharmaceutical quality systems, however if you have worked in a manufacturing environment or have an interest in this area we would still like to hear from you to see how we can help.

Main Purpose of the Job
Provide expertise and guidance to the project in the development of validation strategies and efficient and effective execution of validation and revalidation activities in compliance with Validation policies and procedures. Plan validation aspects for the project and ensuring validation Inspection readiness.
Ensure that all Quality System activities of the project comply with the current Corrective and Preventive Action (CAPA) exception and Product Quality Review reporting processes. Track effectiveness of CAPA process through metric reporting and elevates significant issues to Quality Systems Team Leader.

Skills / Competencies required
• Preferred honours degree in scientific discipline, other degrees in other disciplines may be acceptable depending upon prior experience or alternatively a person with significant pharmaceutical and GMP experience.
• A comprehensive understanding of Regulatory requirements e.g. FDA, MHRA, ICH is essential. Thorough knowledge of the Validation Lifecycle.
• Wide ranging validation experience in production, lab or QA. Including hosting regulatory Inspections.

Aesica Pharmaceuticals – part of the Consort Medical Group
Aesica is renowned for developing and manufacturing both APIs and finished dose forms to the pharmaceutical industry. We are constantly developing the technical and analytical skills of our people to ensure that we are capable of meeting the ever-changing demands of our customers. Aesica operates across several stages of the pharmaceutical services supply chain:-
• Drug discovery
• Process development
• API manufacture (Active Pharmaceutical Ingredients)
• Formulation development
• Formulated product manufacture
• Packaging (Fill and finish)

We are Head Quartered in Hemel Hempstead and have 6 facilities across Europe.

We have over 1,250 staff we are well established and growing on a daily basis.

Benefits
• Competitive Salary
• Working 37.5 hours per week
• Individual performance bonus
• Salary sacrifice company contribution pension scheme
• Cycle to work scheme
• Childcare vouchers
• Company sickness, maternity, paternity payments
• Long service awards