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Validation Manager


Contact info

Type Permanent
Salary Negotiable
Contact Name Joanna Houston
Contact Telephone +353 (0)1 8724665
Reference BPJH4196
Category Quality - Validation
Location Mainland Europe

Job info

Description

Berkley Pharma & Life Science are currently seeking a Validation Manager for our biologics client based in Belgium.

Role/Opportunity:

  • Manage the Sterile Drugs and Plastic equipment qualification and process validation activities in compliance to cGMP requirements and maintain the processes in an accurate validated state.
  • Manage the validation activities of computerized systems and Electronics Records and Electronics Signature in compliance with Corporate and legal requirements.
  • Develop and deploy the Sterile Drugs and Plastics validation strategy and approach and assure compliance of internal validation procedures with corporate and regulatory standards.
  • Manage the Sterile Drugs and Plastics equipment qualification, process validation and computerized system validation activities and assure compliance with internal procedures.
  • Provide validation expertise, support and quality assurance guidance for the implementation and maintenance of the validated state of production processes
  • Provide support for the implementation of new raw materials and pharmaceutical formulations in terms of validation
  • Provide support to the regulatory affairs group for file submissions.


Skills/Experience:

  • BSc in Engineering, Pharmacy or Science
  • 8+ years experience in equipment qualification and process validation with a number of years at management level.


Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia

For more information go to http://www.berkley.ie/

To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Joanna Houston on +353 (0)1 8724665 or send your CV to pharma@berkley.ie



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