Cleaning Validation Expert

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View: 165

Update day: 21-03-2024

Location: Stein am Rhein Schaffhausen SH

Category: Executive management Production / Operation

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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Job content

Cleaning Validation Expert

Schaffhauserstrasse , Stein

Duration - 6 months

Job Purpose

Executing and managing cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.

Validation
  • Support site validation planning by writing and maintaining master plans for cleaning processes and ongoing cleaning (as applicable).
  • Author and review cleaning validation protocols & reports, ongoing cleaning verification protocols & reports.
  • Support execution of cleaning validation activities at the shop floor. Reviews Cleaning Master Batch Records and associated change controls.
  • Confirm revalidation need based on technical changes.
  • Maintain all activities and projects under own responsibility in an inspection ready status.
  • Work collaboratively and cross functionally to help ensure that process risks are analysed, appropriately controlled, and appropriately documented.
  • Ensure that all site validation activities are performed and are in line with the current
  • Organisation’s requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
  • Training:Own the Training Curriculum for own Job Profile.
Skills and Knowledge
  • BSc.in Pharmacy, Chemistry, Chemical / Pharma Engineering, or equivalent. Language:Fluent in English and proficient in German.
  • Preferably 2-3-year experience in manufacturing/ manufacturing science and technology/technical development/quality.
  • Thorough understanding of manufacturing processes and related process equipment.
  • Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
  • Experience in executing process validation.
  • Expert in reviewing and writing technical reports.
  • Fundamental understanding of standard pharmaceutical analytical testing
  • Cleaning Validation in pharma manufacturing field - at least 1 year experience in the relevant field.
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk
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Deadline: 05-05-2024

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