An exciting Pharmaceutical company is currently seeking to hire a QA Operations Lead to guide the department through a period of expansion over the next few years.
Key responsibilities of the QA Operations Lead include :
- Provide leadership to the team of QA officers and QP's
- Define resource needs related to the QA operations team. Ensure your team members are open to development and define training needs.
- Guarantee the compliance of the local quality system to the GMP requirements and corporate standards;
- Lead batch release activities and QP certification of the batches
- Review, define updates and, approve of all the site specific quality system procedures;
- Assure that people are trained on time and track additional training needs. Provide input to training needs and assure that the site associates have appropriate GMP training.
- Provide input to the site master plan and quality plan of the site
- Lead the review of maintenance, qualification, calibration and (re)validation programs at local level;
- Review and approval at site level of OOS/OOT, deviations and complaints
- Ensure the implementation of a supplier approval and review process and support auditing of suppliers and subcontractors
- Support inspections by Health authorities and internal audits. Assure that related CAPA's are implemented on time
- Draft the annual product review (APQR) and propose CAPA's. Assures that relevant quality topics are covered in periodic quality reviews.
- Coordinate the self-inspections as per approved annual plan
- Ensure that all the variations to the Marketing Authorization of a product are implemented at local level
Key requirements of the QA Operations Lead include:
- At least 3 years of experience in a pharmaceutical quality department (QA or QC). Approximately 3 year's of manufacturing experience in a pharmaceutical environment, preferably in aseptic processing is recommended.
- Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills
- Good knowledge of regulatory requirements and cGMP
- Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
- Fluent Dutch and English
- QP Certifications preferred
