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15.09.2020

Quality Manager, Helvic Laboratories

We are currently seeking a Quality Manager to run the quality department in our GMP pharmaceutical laboratory, Helvic in Stoke-on-Trent. Helvic Ltd is owned by Tentamus UK.

 

Tentamus UK comprises a group of five companies specialising in laboratory testing at five different locations in the UK. Helvic Limited is a Microbiology Contract Laboratory providing a range of microbiological testing for the Pharmaceutical industry. Our core expertise is sterility testing and our facility includes a state-of-the art clean room equipped with two grade A sterility test isolators, incorporating hydrogen peroxide gassed technology. Our facilities and capabilities also extend to other pharmaceutical microbiological tests.

 

Reporting to the General Manager this full-time position is responsible for undertaking general QA activities to support the QC function, ensuring excellence in quality and efficient turnaround of results to our customers.

 

Your Primary Responsibilities:

 

  • Maintain a GMP compliant quality system – ensure compliance with current practices and procedures
  • Documentation – coordinate the document management system
  • Quality Assurance – provide process overview and technical input for OOS, deviation, CAPA’s & Quality Incidents
  • Ensure procedures, methods, protocols and reports are implemented as required
  • Highlight potential quality issues quickly and take steps to resolve in a timely manner.
  • Involvement with internal and external audit teams
  • Equipment Qualification – coordinate and provide technical input to ensure GMP equipment is qualified and operational
  • Ensure test reports are checked and released in a timely manner

 

To succeed in this role, you will have the following capabilities: You will have experience working in both a laboratory and cGMP environment. You will be an enthusiastic team member. You will have experience working in Quality Assurance at responsible and supervisory levels. You will have good attention to detail and be proficient in organization while maintaining a supportive and professional working environment. You will be able to inform and direct interested parties on all matters relating to quality systems. In addition, you will have:

 

  • First Degree in microbiology or biological science subject
  • Good documentation skills
  • Effective communication skills
  • Strong analytical and problem-solving abilities
  • Highly computer literate, e.g. Microsoft Office.
  • Well-developed understanding of cGMP systems and processes
  • Candidates must be eligible to reside and work in the UK and will be primarily based at our Stoke-on-Trent office. Must be willing to travel to legal entities within the UK and within Europe as may be required.

 

 

Company benefits include:

25 days holiday

Flexible working hours

Performance bonus scheme

Company pension scheme

 

If you would like to apply for this position, please forward your CV and covering letter to the General Manager – Karen Nash (knash@helvic.co.uk).

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