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???? Role Summary
The QA Specialist will act as the prime quality contact at-site and liaise with external stakeholders. You’ll manage key quality processes—including URS development, change control, protocols, and pre- & post‑approval activities—while collaborating in cross-functional teams.
???? Key Responsibilities
- Serve as the main QA contact at the site and within external quality working groups.
- Oversee QA deliverables: URS, protocols, reports, change controls, and approval sign-offs.
- Participate in cross-functional initiatives as a QA subject-matter expert.
- Coordinate and attend Quality Working Group meetings, ensuring alignment with cGMP standards.
???? Qualifications & Requirements
- Proven QA experience in a biopharmaceutical or similar regulated environment.
- Strong, demonstrable knowledge of cGMP regulations.
- Excellent organization, planning, and time-management skills.
- Self-starter with flexibility to thrive in a fast-paced, dynamic setting.
- Exceptional attention to detail.
- Proactive communication style and effective cross-functional collaboration.
- Motivated team player with stakeholder-focused attitude.
???? Benefits & Contract Details
- 12‑month contract with a biopharma leader in the Connaught region.
- Opportunity to contribute to a growing site and quality infrastructure.
- Collaborative and supportive working environment.
- Fully remote support not guaranteed—site-based presence expected.
✅ Application Details
- Salary Range: Not disclosed
- Application Deadline: July 31, 2025
- How to Apply: Submit your CV and cover letter via this link: Apply Now
