Complaints Quality Assurance Specialist

13 hours ago

Tredegar, Blaenau Gwent, United Kingdom PCI Pharma Services Full time
Job Title: Complaints Quality Assurance Specialist

At PCI Pharma Services, we are committed to delivering life-changing therapies to patients worldwide. As a Complaints Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.

Main Responsibilities:
  • Assist the QMS team in ensuring QMS-related tasks are completed within the required timescales and in compliance with regulatory requirements.
  • Produce compliance-related metrics for the site and assist in the provision of data for Quality Management Reviews.
  • Manage and administer Customer Complaints, track corrective and preventative actions from Internal and External audits, and maintain and update the Approved Supplier List.
  • Perform vendor re-assessments, coordinate external audits, and ensure Quality Agreements and TSE Statements are periodically updated within the required timeframes.
  • Assist in the generation of Nitrosamines Statements and author Product Quality Reviews.
  • Provide assistance during inspection readiness preparations, including completing SIPOC.
Requirements:
  • Experience of working within a pharmaceutical environment under GMP.
  • GMP Skill Level 1 is essential for this role.
  • Proficiency in: Word, Excel, and Powerpoint.
  • Previous experience within a Quality department is desirable, ideally within a cGMP/pharma environment.
  • Minimum 5 GCSE's including English, Maths, and preferably a science subject or equivalent pharma industry experience.
  • Self-motivated, good communication skills, and a team player.
Benefits:
  • 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.

At PCI Pharma Services, we are committed to creating a diverse, inclusive, and equitable workplace where everyone can belong and grow. We strive to bring this vision to reality by continuously assessing our people practices, policies, and programs, marketing approach, and workplace culture.

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