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Regulatory Compliance Expert

2 weeks ago

Kilkenny, Kilkenny, Ireland Life Science Recruitment Full time
Compliance Specialist

An exciting opportunity has arisen with a leading pharmaceutical organization in the Life Science Recruitment sector.

Key Responsibilities:
  • Ensure compliance with corporate and regulatory requirements by providing support for SCM/Warehouse/Weigh and Dispense processes, Standard Operating Procedures, Receipt documents, Shipping documents, protocols/reports.
Main Duties:
  1. Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP.
  2. Implement compliance with policies, procedures, and guidelines, and regulatory requirements, and execute Good Manufacturing Practices (cGMP) in daily activities and job functions.

The successful candidate will be responsible for:

  • SUPPORTING THE UPDATING OF STANDARD OPERATING PROCEDURES, SHIPPING & RECEIPT DOCUMENTS, PROTOCOLS AND ASSOCIATED REPORTS.
  • Reviewing electronic logs.
  • ARCHIVING AND RETRIEVAL OF SCM/WAREHOUSE/WEIGH AND DISPENSE DOCUMENTATION.
  • Maintaining and controlling SCM/Warehouse/Weigh and Dispense documentation areas.
  • ACTING AS A COMPLIANCE POINT OF CONTACT FOR ALL SCM/WAREHOUSE/WEIGH AND DISPENSE DOCUMENTATION TOPICS.
  • Assisting in reviewing SCM/Warehouse/Weigh and Dispense operational procedures, training materials, and procedures for various systems.
  • Providing support with audit/inspection requirements to ensure department compliance/readiness.
  • Liaising with site QA Document Control group.
Requirements:
  • Bachelor's Degree with 3+ years' experience in Pharma and Compliance.
  • 3-5 years' experience in a quality role (QC/QA), ideally in a pharmaceutical manufacturing environment.
  • Experience with Warehousing Documentation practices.