Reference Number: JO-2002-446862
Senior Quality Officer
Job Type: Permanent
SENIOR QA OFFICER
Location: Swindon, Wiltshire
Salary: Up to 45,000 and Excellent benefits package
Our client, a globally recognised specialist healthcare and pharmaceuticals business with an extensive product portfolio is currently looking to expand their Quality Assurance function with the addition of a talented, ambitious and responsible Life Sciences Quality Assurance specialist. Reporting to the Quality Manager, and deputising in their absence, this role has been sanctioned in view of the imminent expansion of the business.
As the Senior QA Officer, responsibilities will include (but not be limited to):
Ensuring the supply of products and business operates in compliance with the Quality Management System (QMS) and relevant legislation
Maintaining, supporting and improving the QMS
Promoting the awareness of the QMS and applicable regulatory requirements
Reviewing and approving relevant controlled records
Generating reports on the performance of the QMS
Managing suppliers to investigate product quality complaints and assessing final reports
Supporting / Leading internal audits & external supplier audits
Supporting the Risk Management Process
Approval of local SOPs associated with processes employed by the company
Ensuring the Quality Manager is informed of major / critical issues that may have an adverse effect on product quality, safety or efficacy or compliance.
Maintaining Quality SOPs, ensuring processes support the business, are compliant with current expectations and regulatory requirements.
Providing advice and training on all quality related matters including but not limited to GMP, ISO standards and validation.
The successful candidate will possess:
A degree or equivalent in a scientific discipline is preferred with experience in a Quality environment in the pharmaceutical industry.
An understanding and knowledge of GMP, the legal and routine duties of the QP and RP and the role of the manufacturing and marketing authorisations.
An understanding of manufacturing and packing processes and ability to make sound judgement and recommendations relating to the manufacture of pharmaceutical products.
The ability to introduce, co-ordinate, complete and report on projects.
Familiar with Microsoft Office
At least 5 years experience in a Quality Assurance role at a medicinal product manufacturer
Ability to perform internal audits
Experience and understanding of computer systems validation and associate standards.
Experienced in the use of Electronic QMS systems
Experience in external auditing of contract manufacturers and / or suppliers
Experienced with ISO 13485 QMS and quality assurance of medical devices is advantageous (Not essential)
Experienced with quality assurance of cosmetics and food supplements is advantageous (Not essential)
This opportunity represents an excellent opening for an experienced, self-motivated Quality Assurance specialist to take on a responsible and rewarding role in an exciting, growing Life Sciences business.
If you are interested in this opportunity please call Jim Maddison at Scientific Professionals on +44 (0) 207 822 1710 or send an updated version of your CV via email to firstname.lastname@example.org
Not quite the right role for you? We do operate a generous bonus referral scheme should we go on to place anyone that you recommend to us so please feel free to pass these details forward.