Validation Specialist/ Manager

View more Jobs by
x4 Group
Job Type
Permanent/Full Time
Date Posted
15th November 2017

Job Description

Vacancy: Validation Specialist/ Manager

Location: North West

Salary: Dependent on experience

A Pharmaceutical client of mine based in the North West is currently looking for a Validation Specialist/ Manager to join their team on a permanent basis.

The client is seeking a Validation Specialist/ manager to lead and execute the complete delivery of all validation projects and activities for manufacturing at the site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities.

Validation Specialist/ Manager- Principal Responsibilities

  • To lead and execute Validation activities and Validation assignments supporting all manufacturing and packaging activities at the site involving the qualification of new and existing facilities, utilities, equipment (including sterilization) and computerized systems.
  • Generation of related project documentation including but not limited to validation plans, protocols, reports
  • Execution of validation testing for manufacturing and packaging equipment, utility systems equipment and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
  • Implement revised methods of validation in line with Regulatory requirements that ensure the company is at the forefront of current thinking and are applying best available technique.
  • Provide expertise in sterilisation validation and support external contractors providing sterilisation services.
  • Support the Engineering group with engineering activities related to Validation.
  • Represent the company at all Regulatory Inspections, acting as the principle point of contact for validation responses.
  • Ensure that all critical changes are impact assessed and that appropriate controls/actions are in place to secure ongoing manufacture.
  • Lead validation activities across major projects and will continuously be looking to support continuous validation improvement activities
  • Training of staff in Validation procedures and principles
  • Support other departmental activities as requested by department management or designate.
  • Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.

Validation Specialist/ Manager- Education and Experience

  • Degree in an appropriate scientific discipline.
  • Minimum of 5 years' experience in the validation and qualification of manufacturing/packaging equipment qualification, computer systems validation, utility systems qualification or process validation.
  • Extensive experience in pharmaceutical validation and manufacturing with strong experience of front line involvement with Regulatory Inspections.
  • Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material.
  • Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry, including exposure to the regulatory requirements affecting validation
  • Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.

If you believe you have the relevant skills and experience for this position, please send apply here or send Matthew Wisdom at X4 Group an updated version of your CV  to [You must Apply on line] or call him on [You must Apply on line] because interviews are being arranged from the end of November 22nd.

Key Words: Validation/ Validation Manager/ Validation Master Plan/ VMP/ Pharmaceuticals/ Pharma

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