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QC Analytical Scientist
QC Analytical Scientist
QC Analytical Scientist
Posted 6 days ago
- London, Greater London
- Any
- External
Calling all QC Analysts, this is a unique opportunity to make real change within the Quality field.
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
.
Key Responsibilitie
s:
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) manne
r.
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.
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
.
Key Responsibilitie
s:
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) manne
r.
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.