I'm working with a client in London UK who is a leading Biotech company. You will be closely working with a wider team to make real change within organisations within the biotech field. All while representing company standards like innovation, quality and excellence.

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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.

• As part of the Quality Control team, 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.