Description
A fantastic opportunity has arisen within one of Europe's leading generics organisations for a Quality Assurance Manager to join their wholesale & Commercial Affairs Division based in Surrey. The organisation has a rich generic and OTC product portfolio and are going through a significant period of growth and as a result are in the process of strengthening their Quality Department.Reporting directly to the Head of Quality the Quality Compliance Officer would be required to manage and resolve day to day quality issues with the supplier base.
Key Skills
- Ensures the compliant operation of the Quality Management System and the companies Quality Standards, in those European Markets in which the company is marketed. Administers the QMS.
- Conduct audits of contract manufacturing facilities, to ensure compliance with current European Good Manufacturing Practices and with the requirements of the Marketing Authorizations, to an agreed schedule.
- Manages the follow up of the audits, to ensure effective resolution of inspection observations. Maintains the audit programme database.
- Ensures all relevant Technical agreements are in place and maintained, with the manufacturers, to the agreed schedule. Maintains the TA database
- Manages the agreed schedule for Annual Product Quality Reviews, ensuring the reviews are available for approval to the required birth-dates. Maintains the PQR database.
- Provides support to the business units of any quality investigations relating to the companies products and where applicable liaises with the manufacturing facilities to ensure continuity of supply.
- Provides appropriate GMP training to the local European business units and liaise with the responsible person to ensure compliance.
- Assists in the conduct of internal audits across the business units.
- Provides QA expertise in the assessment of potential future manufacturing partners.
- Contributes to the quarterly European Technical Operations Team Meetings and provide monthly updates to the Head of Quality in support of the Monthly Quality and Regulatory Report.
Experience Required
- Degree in Chemistry or a relevant Life Science.
- Minimum of 5-10 years experience, working within the Pharmaceutical Industry.
- Experience in both Quality Assurance and Production facilities.
- Qualified auditor
- Extensive knowledge of appropriate European regulations and guidelines within the Pharmaceutical Industry
- Additional language skill in addition to fluent English
On offer is a salary of £40,000 - £50,000 plus benefits, for further information and a detailed job specification please do not hesitate to contact Immanuel Ross on
To find out more about Real please visit www.realstaffing.com