Sitemap
A new opportunity as Senior QA Manager (QP, RP) at a rapidly growing pharmaceutical company in Skåne!
We are seeking a structured, self-motivated, and collaborative Senior QA Manager. This role involves both local and international collaboration. Ideally, you live in Skåne as you are expected to be in the office three days a week. You have strong organizational skills, are self-driven, and possess excellent collaboration abilities. You have specialist competence - QA, QP and RP (see more below). Proficiency in Swedish is essential. If you have team leader ambitions, this fast-growing company offers a great opportunity to advance your career.
Senior QA Manager
• Continuously maintain and improve the QMS
• Perform Risk Assessments of Suppliers and ensuring that there is an updated Audit programme in place.
• Established and maintenance of Technical Agreements with all relevant Suppliers
• Work as a RP
• Documentation and investigation of deviations
• Implementation and follow up of CAPAs and Change Control cases.
• Ensuring that Annual Product Quality Reviews are received for all Company Products and that the CMO´s parts are evaluated from the MAHs perspective
• QA-support in internal and external QA-projects
• Build and maintain relationships with existing and new suppliers/manufacturers/distributors
• Back-up complaints handling
• Coordinate/participate in GMP/GDP inspections and audits of the Company
• Ensuring that of the Company QMS is updated with cGMP and cGDP
QP
• Release or reject batches of finished products.
• Participate in Authority inspections.
• Participate in external audits, remotely or on site
• Provide QP-support and ensure the appropriate documents have been approved.
• Issue QP Declarations for sites/API that are certified to meet GMP requirements.
• Ensure that each GMP batch is produced and analysed in accordance with cGMP, the Quality Assurance Agreements and the Marketing Authorisation and national law
• Ensure all sites involved in manufacture and testing have been audited and that audit reports available
• Ensure all sites of manufacture are compliant with the terms of the MA
• Ensure all manufacture are compliant with the terms of the MA
• Ensure the source and specifications of materials used are compliant with the MA
• Ensure APIs have been manufactured & distributed in accordance with GMP
• Ensure finished product test data complies with the specification in the MA
• Ensure all investigation related to the batch being certified have been completed to a sufficient level to support certification
• Ensure the required TA are in place
RP
• ensuring that a quality management system is implemented and maintained
• focusing on the management of authorised activities and the accuracy and quality of records
• ensuring that initial and continuous training programmes are implemented and maintained
• coordinating and promptly performing any recall operations for medicinal products
• ensuring that relevant customer complaints are dealt with effectively
• ensuring that suppliers and customers are approved
• approving any subcontracted activities which may impact on GDP
• ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
• keeping appropriate records of any delegated duties;
• deciding on the final disposition of returned, rejected, recalled or falsified products
• approving any returns to saleable stock; ensuring that any additional requirements imposed on certain products by national law are adhered to
Contact me for a discussion regarding this possibilty and for more information about the company!