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Validation Specialist (Projects)

Zoek Pin Hertford, Hertfordshire, England

Permanent (Full time)

Validation Specialist (Projects) - Permanent - Biopharmaceutical - Hertfordshire

Our client is a leading Biopharmaceutical manufacturer that are currently seeking a Validation Specialist on a permanent basis.

Key responsibilities:

  • Experienced in the qualification lifecycle for manufacturing systems.

  • Familiar with VMP, FAT, SAT, DQ, IQ, OQ, PQ

  • Experienced in writing and executing DQ, IQ, OQ, PQ for manufacturing systems

  • Experienced in the qualification lifecycle for manufacturing systems.

  • Familiar with VMP, FAT, SAT, DQ, IQ, OQ, PQ

  • Experienced in writing and executing DQ, IQ, OQ, PQ for manufacturing systems

  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.

  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.

  • Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.

Ideal:

  • Good understanding of ISPE requirements, including integrated C&Q

  • Familiar with sterile manufacturing

Posted 1 days ago

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