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QC Scientist

2 months ago

London, Greater London, United Kingdom Life Science People Full time
Unlock Your Potential in Quality Control

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

Key Responsibilities:

  • Conduct gene therapy product testing according to product specifications, ensuring timely completion and alignment with production schedules.
  • Operate and maintain laboratory equipment, ensuring calibration and readiness for use according to test schedules.
  • 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 regulations 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.