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Validation Consultant

3 months ago

Cambridge, Cambridgeshire, United Kingdom PM Group Full time

Validation Consultant:

  • Contract
  • Onsite
  • Cambridgeshire, United Kingdom
  • CQV
  • 7343
**Overview

  • PM Group is looking for an Equipment Validation Consultant to support an API site in East Anglia to join them at the end of September.
**Responsibilities

Responsibilities:

  • Equipment biased
  • Dissolution of vessels, list reactor, spray drier and secondary drier
  • Generation and execution of validation protocols and reports (including IQs, OQs, PQs, etc.) for XYZ.
  • To coordinate validation efforts on site, as directed and as appropriate.
  • To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan.
  • Leading and supporting FATs and SATs.
  • Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
  • Ensuring manufacturing equipment is qualified in line with production schedule requirements.
  • Developing and writing validation procedures according to cGMP and regulatory requirements.
  • Generating and executing validation documentation.
  • Providing continuous improvement for existing validation procedures.
  • Data collation and analysis via sophisticated computer software.
**Qualifications

Qualifications:


Applicants will have experience of equipment validation on multiple projects in the pharmaceutical, API or biopharmaceutical sectors, with an number of years industry experience preferred.

Excellent coordination skills and communication skills are essential.

Outside IR35.