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Validation Systems Officer - Pharmaceutical Processing and Manufacturing

  • Job Type: Permanent


Our Client is a well-established expert in the pharmaceutical, nutraceutical, biopharmaceutical and biotechnology processing and manufacturing industries.

They are now seeking a Validation Systems Officer. This position will be based near Southampton, Hampshire. The position is a full-time permanent role.

Job Purpose

  • To administer the production of all qualification documentation packages for both in-house and external site related testing and qualification activities in accordance with the Company’s Quality Management Procedures

Key Responsibilities

  • To be familiar with, and act in accordance with, all relevant health and safety management legislation
  • To be familiar with, act in accordance with, and help develop the company quality systems rules, regulations and policies
  • To follow GAMP (Good Automated Manufacturing Practice) principles as appropriate, ensuring validation methods are consistent with the approach and that quality is built into each stage of the processes
  • Verification of certification for project qualification
  • To administer and control qualification related documents required for each project
  • Will collate and present required technical documents, test, inspection, and material certification required by the project
  • To determine requirements for material certification on each project and liaise with appropriate departments (including Engineering and Procurement) to ensure specifications are correct
  • When required, resolve certification issues with suppliers
  • To create and manage the standard templates for production documentation including; Assembly Protocols, Logbooks and Machine Labels
  • To ensure all qualification documents including reference documents are completed, signed off and archived as appropriate before release of originals to customers, both at FAT (Factory Acceptance Tests) and at the SAT (Site Acceptance Test) (IQ / OQ) phase
  • To conduct and assist the Project Team in the execution of Factory Acceptance Testing with or without customer attendance
  • Review and verification of completed FAT documents
  • To represent the Validation Team when required
  • To assist in all related test and qualification activities where appropriate to provide assistance and to aid the on-going improvement of documentation systems
  • To provide administrative support for all documents in the qualification scope
  • To maintain the Validation procedures and any required improvements
  • To ensure the project documentation is completed in line with the company procedures, project schedules, and customer requirements

Qualifications and Experience

  • Degree in Engineering or any related technological science, preferably in the field of process engineering
  • GAMP qualification
  • Lean Six Sigma Training is preferable
  • Experience in Validation Systems
  • Experience of Change Control procedures
  • Experience in developing & managing documentation processes
  • Knowledge of Pharmaceutical qualification procedures
  • Ability to work across all departments to affect positive change
  • Ability to lead on documentation matters as necessary

In return, our Client is offering a basic salary of £35,000- £40,000 per annum plus benefits (Salary is negotiable and dependent on experience).

To apply for the above position, please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.

  • Job Type: Permanent

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Southampton, England, Southampton, SO14, United Kingdom

  • Ad ID:  15287014
  • Ad Type:  Offered
  • Posted on:  16/08/2020, 02:52
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