CK Group is recruiting for a QA Manager to join a biopharmaceutical company at their site based in Carrigtwohill, near Cork on a 12 month contract basis.
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.
The Role: The QA Manager will work closely with the rest of the Quality-Distribution team to ensure Good Distribution Practices compliance as it relates to the supply of drug products from the company's Ireland site to their end customers via Affiliates, commercial distributors and Access Operations & Emerging Markets (AOEM) distributors.Key Responsibilities include:
- Support initial due diligence checks of potential new AOEM distributors
- Provide routine support to company partners
- Generate and maintain Quality Agreements between Irish entity and company Affiliates/ 3rd party Distributors
- Documentation review & approval for in-market GMP/GDP activities performed by 3rd parties
- Generate and update controlled documents as needed, to ensure compliance with applicable quality objectives and regulatory requirements.
- Perform & Support gap analysis and risk assessments on processes within Cork and Dublin, Affiliates and Distributors or wherever they may be required, to evaluate compliance to relevant GDP regulations/guidelines & implement/support the implementation of corrective actions
- Lead and/or participate in small cross-functional working groups to deliver processes & procedures under the Corporate Support Model initiative for the EU and ROW Affiliates
- Maintains programs and processes to ensure high quality products delivered to customers and compliance with current Good Distribution Practices.
- Collaborate cross-functionally with local and global colleagues to identify and implement process improvements in distribution of raw materials and finished products
- Participate in developing & delivering training as it pertains to GDP
- Participate in internal and external compliance audits as required, including audits of potential new distributors and on-site visits.
- Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain
- Participate in inter-site global projects in the area of distribution of APIs and Finished Products
Your background: To be considered for this role you should have the following key skills, knowledge and experience
- Demonstrates proficiency in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP)
- Familiar with the concepts of supply chain dynamics between freight forwarders, carriers and handlers related to the supply and delivery of pharmaceutical materials.
- Understands the time & temperature sensitivity of pharmaceutical material and concepts related to product stability, product labelling and risk management.
- Demonstrates excellent knowledge of regulations and guidelines associated with distribution supply chain of medicinal products and APIs
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
- Demonstrates working knowledge with good proficiency in Microsoft Office applications.
- Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is beneficial.
- Knowledge of Six Sigma, Define-Measure-Analyse-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46069 in all correspondence.