QC Scientist

1 day ago


London, Greater London, United Kingdom Life Science People Full time
Job Title: QC Analytical Scientist

We are seeking a highly skilled QC Analytical Scientist to join our team at Life Science People. As a key member of our Quality Control team, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities:

  • Conduct gene therapy product testing according to product specifications, ensuring completion within the required timelines and in alignment with the production schedule.
  • Operate and maintain laboratory equipment, ensuring all equipment is calibrated and ready for use according to the test schedule.
  • Document and manage out-of-specifications, non-conformances, investigations, analysis, and implementation of corrective actions as needed.
  • Assist in the development and updating of SOPs and lab documentation.
  • Facilitate the flow of information by maintaining communication and ensuring information folders are up to date with the latest versions/communications.
  • Complete all required training in a timely manner and support the training activities of other employees as needed.
  • Maintain QC facilities to meet GMP standards, conduct necessary checks, and support health authority, customer, or stakeholder site visits.
  • Contribute to maintaining the Quality Management System, document control, and ensuring the data integrity of all produced data. Also provide support during external or internal audits as required.
  • Ensure work complies with GMP, Data Integrity, and Good Documentation Practice (GDP), and is conducted in accordance with applicable procedures.
  • Ensure timely closure of any assigned GMP documentation, such as issues, CAPAs, Change Controls, BMRs, and audit/inspection actions, ensuring it is completed in a Right First Time (RFT) manner.

Requirements:

  • Have knowledge in regulation such as, EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc...
  • Knowledge in a GMP environment and quality control within the pharmaceutical industry
  • ​Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical field.

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