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QC Validation Specialist

Job title: QC Validation Specialist
Contract Type: Contract
Location: England
Industry:
Salary: £40 - £55 per hour
Reference: BH-127693
Contact Name: Daniel Leach
Phone Number: 01
Job Published: 2 months ago

Job Description

I have an exciting opportunity for a QC Validation Specialist to work a 2 year contract for a global pharmaceutical company in the North West UK.

Role Responsibilities.
  • To co-ordinate the validation activities within the production facilities at site to ensure that the appropriate site and regulatory standards are applied and work is completed in a timely manner
  • To operate within the required standards of HSE, company Quality Systems and policies in accordance with Orange Guide, EU and CFR regulations. 
  • To perform accurate and reliable laboratory tests and generate, report and approve results to cGMP standard, in accordance with current company requirements and SOPs.
  • The role holder is required to write and execute validation protocols following ICH guidelines and other organisational standards; to promptly write reports on completion of execution of the validation/verification studies.
  • The role holder will be required to participate in planning and execution of projects including monitoring ongoing validation exercises and providing regular updates on progress, communicating possible issues that may affect timelines and milestones.
  • To ensure that the maintenance, qualification and calibration of laboratory equipment used is up to date and at the required GMP standards and to participate in method/instrument troubleshooting.
  • Effective communication both written and oral on a daily basis with colleagues at all levels, to include liaison with QA and Operational/Team managers.
  • To co-ordinate the validation activities within the production facilities at site to ensure that the appropriate site and regulatory standards are applied and work is completed in a timely manner
  • To operate within the required standards of HSE, company Quality Systems and policies in accordance with Orange Guide, EU and CFR regulations. 
  • To perform accurate and reliable laboratory tests and generate, report and approve results to cGMP standard, in accordance with current company requirements and SOPs.
  • The role holder is required to write and execute validation protocols following ICH guidelines and other organisational standards; to promptly write reports on completion of execution of the validation/verification studies.
  • The role holder will be required to participate in planning and execution of projects including monitoring ongoing validation exercises and providing regular updates on progress, communicating possible issues that may affect timelines and milestones.
  • To ensure that the maintenance, qualification and calibration of laboratory equipment used is up to date and at the required GMP standards and to participate in method/instrument troubleshooting.
  • Effective communication both written and oral on a daily basis with colleagues at all levels, to include liaison with QA and Operational/Team managers.
For futher details on this exciting opportunity please submit your cv or reach out to me directly. 

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