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Quality Assurance Specialist

2 months ago

London, Greater London, United Kingdom Fagron GmbH & CO. KG Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Fagron GmbH & CO. KG. As an Apprenticeship Quality Assurance Officer, you will play a critical role in ensuring the quality and safety of our medicinal products.

Key Responsibilities
  1. Equipment Management: Ensure that all calibrated equipment is properly managed, identified, and tested according to a suitable schedule.
  2. Safety and Compliance: Ensure the safe operation of all equipment used, including pH meters, balances, and fume cupboards, and maintain a clean and efficient pharmacy environment to meet health, safety, and GPhC compliance standards.
  3. Collaboration and Documentation: Collaborate with the R&D team to ensure new products meet quality standards, and create and review documentation such as SOPs, Risk Assessments, and other Quality documents in accordance with ALCOA/data integrity requirements.
  4. Quality Control and Assurance: Work with the Quality Technician to sample and test raw materials upon receipt, and finished products to assess BUD, and support the complaints resolution process.
  5. Deviation and Change Control: Support in raising deviations, CAPAs, and change controls to assess the impact on quality, safety, and efficacy, and ensure compliance with all relevant pharmacy processes and safety instructions.
  6. Reporting and Communication: Timely and accurate reporting of data, including KPIs, metrics, SLAs, and tasks, and support additional tasks as requested by the Production Manager.
  7. Continuous Improvement: Positively respond to changes in priority while maintaining quality and meeting defined timeframes, and perform self-inspections and write reports on the results.
  8. Teamwork and Collaboration: Attend and participate in relevant meetings and support regular inspection meetings with representatives from appropriate departments to establish an action plan for improving build quality.
About Us

Fagron GmbH & CO. KG is a company that values passion, accountability, growth, and success. We are driven to do our best every day by creating an imaginative and fun place to work. We believe in taking responsibility for our actions and operating in an open and straightforward manner. We are committed to growth and success through learning, teamwork, creativity, and curiosity. We value honesty and respect, and we work with transparency, integrity, and compassion for others. We believe in communication, being open, sharing feedback, and asking questions. We are considerate and put others first.