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Company Info
Opus Recruitment Solutions Ltd

Company Profile

Senior Process Validation Specialist - Pharmaceuticals/Biotech

Posted by Opus Recruitment Solutions Ltd on 11.23.2017
Job ID: 1165928
Location: Not Specified, South West, United Kingdom
Job Category: Engineering
Salary: £58,500.00 per year
Job Views: 620
Post Code:
Employment Type: Full time
Posted: 11.23.2017

Job Description

A Pharmaceutical company in the South West of England are seeking a Senior Process Validation Specialist to join their team on a permanent basis.

This is an excellent organisation who manufacture unique products & retain staff well due to the fantastic working environment!

The site consists of around 300 staff who perform a range of activities within Quality Control & Quality Assurance, process & analytical development in line with the manufacture of biopharmaceuticals as well as a contract manufacturing offering.

You will report into the Validation Program manager and work in a team of 25 specialists who cover all types of Validation. You will be responsible for the coordination of Process Validation activities across the site.

You will lead the site and direct reports in the documentation & execution of Process validation activities in support of medicinal products, regulatory inspections & technical customer support.

The main duties & responsibilities of the role include:
  • Lead the site to ensure Process Validation activities are undertaken in accordance with the Validation Master Plan, Validation Policy and Process Validation procedure
  • Write, review & approve Process validation protocols prior to execution and report generation
  • Coordinate with stakeholders the completion of validation studies
  • Assess Change control documentation to determine change impact for validation status and report appropriately
  • To lead Process Validation discussions during audits
  • To support operational areas in the implementation of change
  • To ensure stakeholder expectations are managed and projects are delivered to current GMP standards
  • Completion of Deviations and the closure of CAPAs
Candidates must have the following skills and experience:
  • Degree in Science or Engineering or equivalent & ideally an academic achievement
  • Must have Hands on process validation experience
  • Must have an understanding of the validation life cycle
  • Project management experience
  • Biotechnology experience
  • Ideal to have experience with the evaluation of statistical data
  • Line management experience including coordinated cross functional teams
If you are interested in applying and learning more about the role, please send an updated CV with an overview of your experience & notice period or availability to start a new role.

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