ETeam was formed in 1999 with the goal of becoming the company of choice for clients, talent, and staffing professionals. Today, we’re one of the fastest-growing global employment agencies and ranked as one of the best companies to work for by Staffing Industry Analysts. We aspire every day to do quality work for our clients and help our talent work at some of the most amazing companies.
ABOUT THE PROJECT
* Position: Quality Specialist
* Location: Clonmel, Ireland
* Type of contract: Fixed Term Contract for 11 months with hourly pay rate
* Our client: A global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines to improve human and animal health. With a strong commitment to research and development, the company focuses on addressing some of the world's most pressing health challenges.
SUMMARY
The Quality Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the site.
ROLE FUNCTIONS:
1. Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
2. Perform and review complaints and deviation investigations, change controls and CAPA’s.
3. Create and maintain assigned SOPs.
4. Compile data for reports and presentations, provide data interpretation and draw conclusions.
5. Complete audits to ensure compliance to SOPs, GMPs and applicable regulations.
6. Support product recalls and stock recoveries as appropriate.
7. Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
8. Identify compliance gaps and make recommendations for continuous improvement.
9. Assist in the induction process for new starters and training of other staff.
10. Generally, follow standard procedures and consult with manager/supervisor on exceptions.
11. Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
12. Keep abreast of cGMP requirements as described in applicable worldwide regulations.
13. Represent department on cross functional teams.
14. Additional activities as assigned by the manager/supervisor.
EXPERIENCE, SKILLS AND QUALIFICATIONS
1. A degree in a Science or Engineering discipline plus some industrial experience.
2. Excellent communication and organizational skills.
3. Knowledge of quality procedures and legal regulations related to the release of products and processes.
4. Experience in applying Good Documentation Practices (GDP).
5. Knowledge of GMP (Good Manufacturing Practice) regulations and regulatory requirements related to the release of pharmaceutical products.
6. Attention to detail, accuracy, and a strong focus on workplace safety.
7. Ability to work independently with moderate supervision.
8. Appropriate level of knowledge and skills for the position.
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