Country Quality Lead - County Dublin
3 days ago
Job description
Job Overview
Our Client, a research based pharmaceutical company, who specialise in research, development, and distribution of novel therapies for rare diseases, are seeking to recruit an experienced and dynamic Country Quality Lead to join their team. The successful candidate will support the organisation in managing the Pharmaceutical Quality System. The successful candidate will work closely with Quality, Regulatory, Safety and Supply Chain Groups while maintaining high quality and client satisfaction.
Key Responsibilities
- Collaborate with the broader quality team to build and maintain a strong and compliant pharmaceutical quality system within the company and its affiliates.
- Support the company's pharmaceutical quality system for the scope of a wholesale distribution authorisation.
- Support the company's pharmaceutical quality system for quality assurance shared services for all products with marketing authorisations.
- Assist in creating and maintaining company quality documentation, including quality manuals, policies, and standard operating procedures.
- Assist in developing and maintaining the company's quality training system.
- Support the artwork approval process.
- Monitor quality incidents to ensure timely resolution of actions and maintain visibility of status.
- Provide support for recalls, complaints, corrective and preventive actions, change controls, and quality incidents.
- Support the audit program, including both internal and external audits.
- Provide data to support the quality management review.
- Collect data and maintain technical product files.
- Provide day-to-day support for the activities of the quality team.
- May be required to act as the quality point of contact in the event that the RP is temporarily unavailable.
- Interested in receiving training to become a RP.
Core Skills/ Attributes
- Ability to work under pressure in a fast-paced environment and remain flexible when needed.
- Highly motivated and self-directed, capable of multitasking and working with minimal supervision.
- Ability to work independently, self-driven, responsive, and results-oriented.
- Strong team player with a positive attitude and a collaborative approach to work.
- Highly collaborative, with regular interaction with teams across Quality, Regulatory, Safety, and Supply Chain departments.
- Knowledge and experience with Good Manufacturing Practice guidelines (EudraLex Volume 4) is a plus.
- GMP auditing knowledge and practical skills, including experience both hosting and performing audits.
- Thorough understanding of regulations related to Good Distribution Practice for medicinal products for human use.
- Good technical knowledge of HPRA guidelines associated with Good Distribution Practice of medicinal products for human use.
- Proficient in using Microsoft 365.
Qualifications
- A scientific degree with a strong preference for pharmacy graduates.
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