Validation Specialist - BPL Recruitment


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Jobs: Production

Validation Specialist

Department
Validation
Job Type
Permanent
Posted
05/05/2016
Closing
30/10/2017
Salary Grade
£35,000 - £40,000 per annum
Job Band
B

Details

An exciting opportunity has arisen to for a Validation Specialist to join Bio Products Laboratory LTD, a niche pharmaceutical business based near to Watford at a time where it is embarking on a programme of investment in all parts of the business. 

The main job purpose of the Validation Specialist is:

  • Responsible for key aspects of the day-to-day validation planning and qualification testing within Validation Compliance Unit as outlined in the duties below.
  • Co-ordination and execution of process / equipment / system verification/qualification.
  • Result reporting associated with plans, protocols and regulatory requirements defined by validation management, BPL stakeholders, and regulatory inspections.
  • Co-ordination of validation test equipment, resources and support staff / contractors to ensure validation / verification / qualification is correctly controlled in respect to secure storage, annual service and renewals, accuracy checks.

Key duties and responsibilities:

  • Ensure routine requalification for critical items of manufacturing equipment and services are planned and carried out to meet production schedule requirements.
  • Ensure validation plans, protocols and testing are created and performed in accordance with BPL Site Validation Master Plan and associated validation procedures.
  • Ensure validation plans, protocols and testing are created and performed to agreed schedules and work patterns to minimise interruption to production operations.
  • Ensure validation testing is performed at necessary times with agreed stakeholders including peak and off peak operating periods (which may include shift cover and weekend testing).
  • Determine and write procedures associated with validation exercises and projects according to cGMP and Regulatory (MHRA and FDA) requirements.
  • Investigate, develop and implement new and improved validation procedures to support validation deliverables and execution.
  • Liaise and co-operate with other departments to carry out Validation activities, training and changes as necessary to meet cGMP and regulatory requirements.
  • Advise on validation requirements necessary in area of expertise to maintain compliance with current GMP and regulatory requirements, within the post holder's area of technical specialty.
  • Use of validation equipment and computer software for data collection, collation and analysis of validation / qualification processes and equipment.

The successful candidate will have a strong background within a GMP validation environment. You will either have a relevant degree or significant relevant experience.  You will have previous man management and/ or project management experience. Knowledge of Autoclaves, Sterilisers, freeze dryers and washing machines would be advantageous.


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