LSC have a great contract opportunity for a Quality Specialist to join a top pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution.
About the role
As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.
If you have a degree in Science or Quality and are ready for your next challenge, this could be the perfect project for you!
Overview of the role & Key Responsibilities:
- Documentation, ensuring full compliance with GMP and site-specific requirements.
- Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
- Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
- Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
Qualifications & Education:
- Degree in Science, Quality, or a related Technical field.
- 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
- Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa.
We regret that we are unable to provide visa sponsorship at this time.
Thank you for your understanding.
Apply via this advert or contact Siobhan Cummins on 0214777329 if you have any more questions about this opportunity!
