Manufacturing Compliance Specialist

2 days ago

Galway, Galway, Ireland beBeeCompliance Full time €60,000 - €80,000

Job Title: Manufacturing Compliance Specialist

This position plays a key role in ensuring the quality and compliance of products manufactured by our company.

Key Responsibilities:

  • Review and approve Master Batch Records, Electronic Batch Records, and production documentation for compliance with Good Manufacturing Practices (GMPs).

  • Provide direct support on the shop floor to ensure accurate documentation and adherence to compliance standards.

  • Review and approve Standard Operating Procedures (SOPs), Work Instructions, and Controlled Job Aides.

  • Support commissioning, qualification, and validation activities for new equipment and facilities.

  • Participate in cross-functional projects and continuous improvement initiatives.

  • Assist during internal audits and regulatory inspections.

  • Drive quality initiatives to improve operational efficiency.

Requirements:

  • Bachelor's degree in a scientific or engineering field (preferred).

  • Minimum 5 years of experience in GMP Manufacturing, Quality Assurance, or a similar role in the biotech or pharmaceutical industry.

  • Strong understanding of cGMPs, regulatory requirements, and QA operations.

  • Proven leadership, communication, and interpersonal skills, with the ability to work in a team environment.

  • Experience in GMP documentation review, process validation, and supporting regulatory inspections is preferred.

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