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Date Added: Wed 14/07/2021

Quality And Validation Specialist

Merseyside, UK
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Job Type: Permanent, FullTime

Salary: £29/hour

Our client a Biotech company, based in Speke is looking for a Quality Validation Specialist to join their growing team.

Reporting to a Validation Manager, the role holder will consult with and receive guidance and direction from the Senior Validation Manager and Validation Managers in order to interpret strategy. They will write and execute validation studies and operate within the confines of industry standards, EC directives, cGMP, regulatory directives, product licenses and company policies and procedures

This is a temporary role for 3 months (possibly longer) to start on 26th July 2021.

Key Responsibilities:

* Delivery of validation activities adhering to production schedule and project requirements.

* Satisfying internal and external customer requirements.

* Co-ordinate the validation activities within the production facilities at Liverpool to ensure that the appropriate site and regulatory standards are applied, and work is completed in a timely manner.

* Delivery of performance measures and validation compliance in line with Quality and HSE regulatory standards (RFT >80%, HSE targets, DR/CAPA/CC on time closure).

* Maintaining training compliance >98%.

* Perform accurate and reliable laboratory tests and generate, report and approve results to cGMP standard, in accordance with current company requirements and SOPs.

* 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.

* 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.

Key Skills/Experience:

* Educated to graduate level in a scientific discipline or equivalent

* Strong cGMP background in the Biological or Pharmaceutical industry

* Experience of sterile manufacturing

* Experience in at least two of the key validation areas i.e., cleaning, sterilisation, process, temperature mapping, media simulations, automation, equipment, and facilities
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