Role DescriptionIn this role you are responsible for leading and directing Quality staff supporting production in the shift. You are the Subject Matter Expert in the assigned area of responsibility and also required to understand and grasp a broad range of quality related competencies. In this role you will be reporting directly to the Plant QA Senior Manager. Next to you will be fulfilling duties of Qualified Person as laid out in EU Directive 2001/83/EC.
Responsibilities- Responsible for leading and directing Quality staff including managing their performance and supporting their development. - Responsible for achieving Plant QA Key Performance Indicators. - Provide real-time QA oversight and support for production operations. - Collaborate with operations to resolve quality and compliance issues, including but not limited to Change Controls, NCs and CAPAs. - Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation. - Support and represent Quality during audits and inspections. - Support Lean Transformation and Operational Excellence initiatives, drives continuous improvement initiatives within plant QA, and drive together with production management reduction of repeating events within plant QA and production. - Execute batch disposition.
Requirements- Master’s degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology or equivalent.Thorough knowledge of the processes involved in clinical and commercial manufacturing. - Typically 5+ years of related professional experience preferable in a pharmaceutical environment (GMP). - Sound knowledge of Good Manufacturing Practice and Good Distribution Practice. - Relevant experience in dealing with Non Conformances and Change Control records. - Minumum of 1 year managerial experience. - Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 68/01 chapter 2.2 (Responsible Person).
Other informationOur client is a Fortune 500 company and invests in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.