Senior Quality Assurance Specialist
5 days ago
RT Lane Recruitment is seeking a highly skilled Senior Quality Assurance Specialist to join their Pharmaceutical Company in Carlow.
This is a 9-month contract with strong potential for extension.
Candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland.
A high volume of applicants may result in only suitable candidates being contacted.
Brief overview of Role:
- Perform quality assurance assignments for Carlow quality systems, processes, and controls.
- The role includes visual and measurement inspections of glass and rubber components.
Key Responsibilities:
- Comply with and execute CGMP/GDP standards in day-to-day business activities.
- Evaluate potential violations of CGMP and other concerns that affect safety, efficacy, quality, or purity of MMD human health products.
- Collaborate to ensure a safe and compliant culture in Carlow.
- Maintain adequate processes and procedures for all Quality activities.
- When required, work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery, and oversight) as per business needs.
- Develop effective cross-functional relationships with other departments to ensure manufacturing, testing, and release of vaccine and biologic products follow cGMP and regulatory requirements.
- Provide quality support for controls and procedures across the material and product lifecycle where applicable.
- Support team members with qualification/validation, technical transfers, and commercial operations at the facility when needed.
- Support team members with tasks related to SOPs, deviations, cleaning verification/validation data, and other documents necessary for the Quality and Manufacturing departments.
Qualifications & Education:
- Third Level qualification in science or a related discipline.
- GMP experience is essential.
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