Validation Manager, South Wales, £Negotiable, Consultancy / Perm

with No Comments

Validation Manager, South Wales, £Negotiable, Consultancy / Perm

 

Summary
An exciting opportunity has arisen for a Validation Manager to join a well-established, progressive pharmaceutical manufacturer based in Carmarthenshire, South Wales who are currently undergoing expansion. The role is a days’ based position working Monday-Friday office hours. This role would suit a Validation Manager, Compliance Manager, Quality Manger, Regulatory Affairs Manager,

 

The Role
Reporting into the Director of Quality, you will be responsible for the day to day validation activities, supporting all sectors including quality, manufacturing, development and logistics.

Day to day validation activities may include overseeing the design and qualification of manufacturing cleanrooms as well as the qualification of new manufacturing equipment including centrifugal, ultrafiltration and chromatography purification technologies in support of new manufacturing processes that will also undergo qualification in compliance with GMP. It may also include ensuring maintenance of existing equipment / process qualification status in compliance with GMP.

Duties will include:

  • Preparing and maintaining a Site Validation Master Plan for the validation and revalidation of equipment, processes assays and computerized system in accordance with regulatory requirements.
  • Assisting in the design and specification for the purchase of new equipment.
  • Being involved in factory acceptance testing of new equipment.
  • Writing protocols and reports for Design, Installation, Operational and Performance Qualifications of Equipment.
  • Ensuring the temperature monitoring of product distribution is appropriately validated and supported by protocols.
  • Determining acceptance criteria for validation studies.
  • Ensuring that Assay Development is performed in accordance with current ICH guidelines.
  • Ensuring appropriate process validation is carried out in accordance with ICH guidelines
  • Interacts with Managers at all levels throughout the Company.
  • You will have one direct report – a Validation Technician.

 

The Candidate

  • Educated to degree level in a Scientific discipline supported by a minimum of 3 years’ experience in a similar role within the pharmaceutical or allied industry.
  • Have a sound knowledge of, and promote the Company’s Quality System.

 

JK Recruitment
Please be aware that we receive a high volume of interest for each of our roles and we cannot guarantee we will be in touch if you are not shortlisted for the position. At JK Recruitment we aim to provide the best possible opportunity to take your career forward, we will be in touch within the next seven days if your application is successful. Please continue to visit www.jkrecruit.co.uk to keep up to date with further vacancies. We regret that this client is not prepared to sponsor work permit or work permit transfer applications. Candidates must be able to prove their eligibility to work in the UK