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Validation Team Leader

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Scientific
  • Date posted: 15/11/2017
  • Job reference: J377408A

Validation Team Leader

Minimum Qualifications & Experience

  • Qualified to a minimum of Degree level in engineering or related discipline.
  • Minimum 5 year's Validation Engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
  • Proven track record in the industry in process validation and the development of procedures and processes to support best practice.

Responsibilities include, but are not limited to:

Health, Safety and the Environment

  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.

Quality Compliance

  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.

Engineering

  • Ensuring approaches are aligned with current guidelines (ICH/ASTM etc).
  • Integrating as far as possible Engineering activity and validation activity.
  • Developing procedures and processes which ensure Validation activity is integrated into process design and Engineering execution in new projects and processes.
  • Develop the site validation schedule and ensure it is scalable in the event of future additions.
  • Develop validation protocols as required ensuring at all times that acceptance criteria is clear and related to process capability.
  • Ensure the site change control procedure is integrated into documentation and procedures.
  • Manage internal and if necessary external outsourced routine requalification of process equipment.