CK Group are recruiting for a Qualified Person to join a biopharmaceutical company at their site based in Carrigtwohill, near Cork on a on a contract basis for 18 months and has an hourly rate of €70-€90.
The Company: Our client is a biopharmaceutical company that discovers, develops and commercialises innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Their Ireland operations are responsible for manufacturing, quality control, packaging, and the release and distribution of the company's products in the European Union and other international locations.
The Location: This role will be based at our clients manufacturing site in Carrigtwohill. Carrigtwohill, officially Carrigtohill, is a town in County Cork, Ireland with a population of 5,080. It is 12 kilometres east of Cork city and can be accessed via the N25.
- Complie with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
- Certify batches for sale or supply in compliance with regulations.
- Approve Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
- Attend and participate Event Review, Quality Systems Review and Site QP Meetings.
- Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Participate in writing or suggesting changes to controlled documents (e.g. SOPs, Methods, etc.) as needed to ensure defined quality objectives are met.
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Review manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Proficient in application of QA principles, concepts, industry practices, and standards.
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
- Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)) is beneficial.
- Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
- Some years of relevant experience in the pharmaceutical industry and a BS or BA or relevant experience and a MS.
Entitlement to work in the EEA is essential. For more information please contact Natasha on 44 1438 870011 or email firstname.lastname@example.org. Please quote reference 47783 in all correspondence.