QA Specialist II
CK Group is recruiting for a QA Specialist II to join a biopharmaceutical company at their site based in Carrigtwohill, near Cork on a 12 month contract basis and has an hourly rate of up to €26.70.
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.
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.
This is a contract role and this position requires experience and expertise in the support of multiple Packaging and Packaging Engineering projects including review and sign off of associated validation documentation from a quality perspective. The successful candidate will be required to work on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. The candidate will be required to exercise judgment to determine appropriate action with minimal supervision. The candidate will need to have demonstrated proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on packaging, engineering and validation requirements.
- Perform a wide variety of activities to ensure compliance with applicable regulatory requirements through support of Packaging and Engineering functions.
- Work directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Review routine Packaging and Engineering documents including tech trial protocols and reports.
- Develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
- Review and evaluate proposed changes, qualification and validation documentation as related to engineering and manufacturing.
- May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
- May assist with compliance audits as required.
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Demonstrate proficiency in Good Manufacturing Practices (GMPs).
- Demonstrate proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and engineering requirements.
- Previous experience with Change Management, Validation and Commissioning Documentation requirements is highly desirable.
- Demonstrate thorough knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like packaging and engineering.
- Demonstrate strong knowledge of Six Sigma, Lean and root cause analysis tools used for identifying and correcting deviations.
- Demonstrate audit and investigation skills, and report writing skills.
- Demonstrate strong verbal, technical writing and interpersonal skills.
- Demonstrate proficiency in Microsoft Office applications.
- Knowledge and experience of Serialisation a significant advantage.
- Ideally 6+ years of relevant experience in a GMP environment related field and a BS or BA.
- Ideally 4+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
For more information or to apply for this position, please contact Natasha on 44 1246 457739 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 47312 in all correspondence.