Regulatory Compliance Specialist

5 days ago

Bray, Wicklow, Ireland beBeeCompliance Full time €90,000 - €150,000

Job Title: Quality Assurance Specialist

Job Summary:

This role ensures compliance and execution of site operational activities to make sure the site is permanently inspection ready.

The Quality Assurance Specialist-Operations will ensure that the process for the manufacture of Active Pharmaceutical Ingredients is in compliance with cGMP and associated regulatory requirements.

Main Responsibilities:
  • Quality Oversight: Provide quality oversight and support for Operations in manufacturing, testing, packaging, and material management.
  • GMP Compliance: Ensure GMP activities are in compliance with regulatory, corporate, and site procedures.
  • Process Support: Provide in-plant/on-the-shop-floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations, and Warehousing activities.
  • Documentation: Issue batch records and cleaning records and review executed batch records and cleaning records as per site procedures.
  • Review and Approval: Review SOPs, EOPs, Change Requests, Protocols, Reports, etc.
  • Collaboration: Partner with GMT, Laboratories, Operations, and Regulatory to ensure successful transfer and validation of processes.
  • System Development: Support in ensuring compliant systems and processes are in place, validated, and executed as intended.
Organizational Relationships:

Interact with colleagues with a direct reporting relationship as well as indirectly, as part of the site recommissioning core project team through to commercialization.

Adhere and comply with cGMP requirements, including Quality Manuals, Policies, and Procedures.

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