Senior Quality Assurance Compliance Officer

Location
Berkshire
Salary
Compettive
Posted
10 Feb 2017
Closes
10 Mar 2017
Ref
J3543
Contact
Chris Sowden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Senior Quality Assurance Compliance Officer to join a leading Biologic's manufacturing company based in the Berkshire area. As the Senior Quality Assurance Compliance Officer you will be responsible for activities relating to supporting manufacturing operations on Quality and cGMP issues.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Quality Assurance Compliance Officer will be varied however the key duties and responsibilities are as follows:

1. Ensuring all batch related records are reviewed and approved in a timely manner, you will communicate with all departments regarding documentation status.

2. As the Senior Quality Compliance Officer you will conduct the final review of seed folders communicating seed status to relevant departments, as well as conducting periodic Product Quality Reviews.

3. You will take ownership of the deviation management system, maintain the change control system and conduct any internal investigations. It will be your task to raise robust CAPA's or change controls to rectify the problem and prevent reoccurrence.

4. Delivering cGMP training, updating the existing QMS system and participating in regulatory inspections.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior Quality Assurance Compliance Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in a life science discipline, with experience of working in a cGMP environment, within a Quality Management System.

2. Proven industry experience in Quality Assurance within the Pharmaceutical industry, experience with production of a Pharmaceutical product would be desirable.

3. A working knowledge and practical experience with the regulatory requirements for manufacture of licensed medicinal products.

Key Words: Quality Assurance | Pharmaceutical | QA | GMP | Quality | Compliance | CAPA | Change control | Deviations | Audits | Regulations | Quality Management System | Non-conformance | Trackwise | Root Cause | SOP's | Seed Manufacture | Product Quality Review |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.