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Pharmaceutical Quality Manager

3 weeks ago

Dublin, Dublin City, Ireland Next Generation Full time

The Pharmaceutical Quality Manager will be responsible for ensuring the quality and compliance of manufactured products at Next Generation Recruitment. The successful candidate will review process documentation and data for accuracy, completeness, and compliance with data integrity standards.

The Pharmaceutical Quality Manager will support batch disposition activities, assist in deviation investigations, and spend significant time on the shop floor, providing quality coaching and guidance to ensure documentation is completed correctly the first time and meets regulatory requirements.

Responsibilities:
  • Review and approve new and updated Master Batch Records / Electronic Batch Records.
  • Ensure accuracy and compliance by reviewing and approving production documentation such as executed electronic batch records and logbooks.
  • Provide quality presence on the shop floor to support compliance and data integrity.
  • Review and approve new and updated SOPs, Work Instructions, and Controlled Job Aides.
  • Actively participate in Tier processes to surface and resolve quality issues.
  • Provide QA support for commissioning and qualification lifecycle documents for capital projects and new equipment.
  • Serve as the Quality SME for Performance Qualification (PQ) activities, including but not limited to Equipment, Facility, and Utility PQ studies, Cleaning Validation, SIP, and Process Validation.
  • Represent the Quality function in cross-functional projects.
  • Support sustaining activities, including Change Management, Deviations, CAPAs, Equipment Requalification, and Periodic Review.
  • Provide support for internal audits and regulatory inspections.
  • Collaborate with cross-functional teams to drive continuous improvement initiatives.
Requirements:
  • Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance, or Laboratory environments within the pharmaceutical or biotech industry.
  • Expertise in Quality Assurance operations and Regulatory agency engagement.
  • Strong leadership, oral, and written communication skills.
  • Deep understanding of cGMPs and regulatory requirements.
  • Excellent interpersonal skills, with the ability to collaborate in a team environment.
  • Bachelor's degree in a scientific or engineering field.

This position requires a high level of expertise in Quality Assurance operations and Regulatory agency engagement. If you have the necessary skills and qualifications, we encourage you to apply.