Senior Quality Assurance Specialist

Cork
Permanent
Full-time

27 days ago

Senior Quality Assurance SpecialistLocation: CorkIndustry: PharmaceuticalEmployment Type: Full-TimeOur 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

Morgan McKinley

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