Quality Assurance Specialist

2 months ago

Tredegar, Blaenau Gwent, United Kingdom PCI Pharma Services Full time

About PCI Pharma Services

PCI Pharma Services is a leading global contract development and manufacturing organization (CDMO) that provides a comprehensive range of services to support the development and commercialization of pharmaceutical products.

The Role

This is a key position in our organization, responsible for ensuring excellence and regulatory compliance in our quality management systems. The successful candidate will provide technical quality support to our operational departments, ensuring that all products are manufactured in accordance with license requirements, clinical trial applications, and current Good Manufacturing Practices (cGMP).

Main Responsibilities

  • Provide technical quality support to operational departments for new and ongoing projects, ensuring compliance with regulatory guidelines and company policies.

  • Lead the interpretation of business and regulatory guidelines, including EU, US, and Japan regulations, to ensure regulatory compliance.

  • Promote a culture of quality throughout the organization, identifying and addressing non-compliance issues, and implementing quality improvements.

  • Conduct performance audits and follow up on actions within site business units to ensure compliance with quality standards.

  • Review and approve Master Batch Records (MBR), master dispatch job cards, Technical Specifications, and other quality-related documents.

  • Write and review Drug Product Files (DPFs) and Product Specification Files (PSFs) to ensure compliance with regulatory requirements.

  • QA approval of Item Masters and batch record compilation and regulatory checks.

  • Interpret PQR data and review non-compliance identified by audit, deviations, and complaints.

  • Review and approve deviations and change controls as needed, and initiate quality improvements to prevent re-occurrence.

  • Ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application, and cGMP.

  • Assist with GMP training within the department and cross-site to ensure compliance with quality standards.

Benefits

At PCI Pharma Services, we believe that our employees are our most valuable asset. That's why we offer a comprehensive benefits package designed to support your well-being and enhance your overall quality of life.

  • Employer Pension: Secure your future with our employer pension scheme (above statutory pension).

  • Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.

  • Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.

  • Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.

  • Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you

  • Staff Engagement: We value your dedication with recognition schemes and long-service awards.

  • Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.

  • On-Site Subsidized Canteen.

  • Cycle to Work Scheme.

  • Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.

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