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Senior Quality Assurance Specialist

1 month ago

Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time
Job Title: Senior Quality Assurance Specialist

PCI Pharma Services is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.

Main Responsibilities:
  • Review and certify manufacturing processes and activities to ensure compliance with UK and EU GMP regulations.
  • Conduct audits and inspections to ensure that our manufacturing sites and those of our customers meet regulatory requirements.
  • Provide guidance and support to our staff and customers on QP requirements and regulatory compliance.
  • Stay up-to-date with the latest regulatory requirements and industry developments.
  • Collaborate with our quality team to implement and maintain our quality management system.
Requirements:
  • Eligibility to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products.
  • Experience working as a QP in the certification of sterile medicinal products, particularly biopharmaceuticals manufactured aseptically.
  • Strong knowledge of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills.

At PCI Pharma Services, we are committed to providing a safe and inclusive work environment. We are an equal opportunity employer and welcome applications from diverse candidates.