Senior Quality Assurance Manager

5 days ago


Sunderland, Sunderland, United Kingdom CY Partners Full time

Job Title: Senior Quality Assurance Officer

Job Summary:

CY Partners is seeking a highly experienced Senior Quality Assurance Officer to join our team. As a Senior Quality Assurance Officer, you will play a key role in ensuring the quality and compliance of products manufactured on site.

Key Responsibilities:

  • Batch Documentation and Record Review: Review and approve batch documentation and associated records to ensure compliance with Good Manufacturing Practice (GMP) regulations.
  • Audit and Inspection Coordination: Conduct and coordinate GMP audits and self-inspections to identify areas for improvement and ensure compliance.
  • Customer QA Package Preparation: Assist in the preparation and dispatch of customer QA packages to ensure timely and accurate delivery.
  • Investigation and Deviation Support: Participate in investigations, deviations, and change controls to ensure prompt and effective resolution.
  • Quality Management System Maintenance: Support the maintenance of quality management systems to ensure ongoing compliance and improvement.
  • GMP Training and Guidance: Provide GMP training and guidance to staff to ensure a culture of quality and compliance.

Requirements:

  • GMP Regulations: Strong understanding and experience working with GMP regulations.
  • Pharmaceutical Quality Assurance: Proven background in pharmaceutical quality assurance (QA/QC).
  • Attention to Detail: Excellent attention to detail and documentation skills.
  • Teamwork and Communication: Ability to work effectively both independently and as part of a team, with strong communication and interpersonal skills.


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