Our Client is an independently owned and operated company that works exclusively with clinical trial materials. The UK site provides secondary packaging (labeling and kitting) of any dosage form into plain packaging to ensure blinding of supplies for clinical trials, and storage and distribution of clinical materials for use in clinical trials. Their facility near Reading serves as the distribution hub for the packaged clinical trial materials to Europe and the rest of world.
They are now seeking a QA Manager & Responsible Person to join their dynamic team. This position is a full-time permanent role reporting to the Managing Director and will be based near Reading, Berkshire.
Job Purpose
This position is responsible for managing the Quality Assurance department and ensuring the overall EU GMP/GDP compliance of the organisation.
Key Areas of Responsibility

• Named as the primary Responsible Person in the WDA(H) Licence and as the Quality Controller in the MIA IMP and MS Licences
• Responsible for the generation, revision and review of Standard Operating Procedures, Quality Master Plan, Site Master File, policy documents and other GMP/GDP documents
• Responsible for the internal SOP training of all employees, keeping track of their training and maintaining their training records
• Responsible for ensuring that GMP/GDP documentation are properly controlled and that appropriate systems exist for the scanning, filing and archiving (manually & electronically) of all pertinent documents
• Responsible for providing QA support to all GMP/GDP activities including receiving, storing, distributing, returns processing and disposition of products.
• Responsible for providing QA release for products
• Oversees the investigation and resolution of operational discrepancies and client complaints having final approval of outcome, including the writing of reports, driving change and implementing improvement in the assigned areas.
• Oversees and initiates the Corrective Action & Preventive Action (CAPA) programme
• Ensures there is a proper change control procedure in place for documentation, processes and systems
• Performs quality improvement assessments and changes
• Performs and/or participates in internal, supplier, client and MHRA audits as the lead contact
• Approves validation policies and procedures and oversee the proper and full implementation of validation activities
• Oversees GMP/GDP risk assessment programme and ensures that the mitigation strategies are identified and implemented
• Responsible for overseeing the approval of material specifications and other related documents
• Oversees the tracking and updating of product expiration dates

Qualifications and Experience

• Bachelor's Degree or equivalent
• Managerial experience
• Strong understanding of GMP and GDP in the Pharmaceutical industry
• Familiarity with GCP in the Clinical Trials industry
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Experience in examining and re-engineering operations and procedures, formulating policy and developing and implementing new strategies and procedures
• Excellent reading and writing skills
• Excellent problem solving / investigational skills
• Excellent mathematical skills
• Effective time management skills
• Strong attention to detail
• Strong computer literacy skills
• Ability to make administrative and procedural decisions and judgments

In return our client is offering a competitive package for the successful Candidate including a basic salary of GBP50,000 - GBP60,000 per annum plus benefits. (Salary is negotiable dependent on experience)

Please send your C.V and covering letter to Lorraine Roger, Director at Atom Recruitment Ltd.