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QC Analytical Specialist

2 months ago

London Area, United Kingdom Life Science People Full time

Join Life Science People as a QC Analytical Specialist

We are seeking a highly skilled QC Analytical Specialist to join our team in the Quality Control department. As a key member of our team, you will play a critical role in ensuring the quality of our products and services.

Key Responsibilities:

  • Conduct gene therapy product testing in accordance with product specifications, ensuring timely completion and alignment with production schedules.
  • Operate and maintain laboratory equipment, ensuring all equipment is calibrated and ready for use as per 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 Standard Operating Procedures (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 Good Manufacturing Practice (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:

  • 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.
  • Relevant degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical field.