▷ (8/9/2025 A) Senior Quality Assurance Specialist

2 weeks ago

Cork, Ireland Morgan McKinley Full time

Senior Quality Assurance Specialist

Location: Cork

Industry: Pharmaceutical

Employment Type: Full-Time

Our client, a leading global pharmaceutical organization, is seeking a Senior Quality Assurance (QA) Specialist to join their dynamic team. This is a fantastic opportunity for an experienced QA professional to work in a high-impact, compliance-driven environment and play a pivotal role in ensuring product quality throughout the lifecycle.

Key Responsibilities:

- Ensure full cGMP compliance in all project- and product-related activities and systems.
- Develop and implement quality policies, procedures, and continuous improvement initiatives.
- Support supplier qualification processes and collaborate closely with Procurement and external partners to ensure quality standards are met.
- Lead and manage all quality aspects of assigned projects and products, ensuring compliance with regulatory and internal standards.
- Oversee a broad range of QA-related areas such as:

-Raw materials, supplier management, production processes

-Specifications, change control, deviations, CAPA

-Batch release, cleaning validation, audits, and customer complaints

-Quality documentation, stability programs, regulatory compliance

- Provide quality support for the introduction of new products, including document review and approval.
- Ensure that all activities comply with Health, Safety, and Environmental standards.
- Be present on the manufacturing floor to offer real-time support and oversight.

Qualifications & Experience:

- Bachelor's degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering
- 5 years of QA experience in a GMP-regulated pharmaceutical environment - mandatory
- Hands-on experience in a GMP operational setting
- Strong knowledge of GMP standards and regulatory requirements

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