Manager Qualified Person, QP required by our client, a large pharmaceutical company based in the South East. As Manager QP, you will be responsible for ensuring that all products being released for commercial or for clinical trial purposes comply with the requirements of the Marketing Authorisation, or Clinical Trial Authorisation, have been manufactured according to the principles of GMP as per Directive 2003/94/EC.
Responsibilities Include :-
A day in the life of our Manager Qualified Person (QP)
- To ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the cGMP/cGLP/Regulatory and licence requirements
- To ensure all batch related documentation is completed and endorsed by relevant trained personnel.
- To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements.
- To identify and make recommendations for improvements to the process within the overall Continuous Improvement process of the Company.
- Outlining batch investigation requirements and responsibilities.
- Releasing batches as per scheduled shipment date (where possible).
- Ensure the principal manufacturing and testing processes have been validated.
- All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records.
- Any planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to and approval by the HPRA..
- Any additional sampling, inspection, tests and checks have been carried out or initiated as
Role will suit:
- Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status as defined by E.C. Directive 2001/83
- Proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance role.
- Excellent knowledge of regulations and sources of regulatory information.
- Knowledge of Report Writing
- Experience of Accomplishing tasks through concern for all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; maintaining watchfulness over a period of time.
- Experience of Securing relevant information and identifying key issues and relationships from a base of information; relating and comparing data from different sources; cause-effect relationships.
- Knowledge of company procedures, policy and standards (SAP)
- Authority to approve/reject product batches
- Experience of Review / approval of investigations into incidents before releasing a batch
- Review / approval of Out-of-Specification investigations before releasing a batch
- Experience as QP for release only of product types for which they possess the relevant experience or knowledge
- Experience of Co-ordinating / being involved in recall decision