QA Manager Process Validation

☞ Tradice

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Update day: 26-03-2024

Location: Visp Valais VS

Category: Sales Pharmaceutical / Chemical / Biotech Arts / Design Part-time

Industry:

Job type: Temps partiel

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Job content

Summary

The QA will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

Accountabilities

  • Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to company procedures, and in compliance with regulatory guidance
  • Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
  • Leading the process validation teams including communication with customers
  • Support R&D teams during the process design phase
  • Preparation of the validation protocols and reports for the studies performed at manufacturing scale
  • Assessment of changes and deviations during manufacturing for their impact on validation

Candidate profile

  • Education: Master Degree in Chemistry or Biotechnology (PhD preferred)
  • Experience:

Proficiency in writing scientific reports in English

Experience in GMP manufacture preferred

Languages: Fluency in English and German required

  • General skills:

Excellent communication skills

Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond o Managing internal and external customer relations professionally and effectively

Application open to any EU candidates, due to the competitive salaries, no relocation packages are included, the successful candidate will be required to relocate to the location.

Contract renewal and/or permanent contract is entirely dependent on the job performance.

Contract length: 12 months

Job Types: Part-time, Contract

Ability to Commute/Relocate:

  • 3930 Visp, VS: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Master’s (Required)

Experience:

  • writing scientific reports in English: 1 year (Required)
  • GMP manufacture: 1 year (Preferred)
  • APIs and Intermediates: 1 year (Preferred)
  • Validation Master Plans: 1 year (Preferred)
  • manufacturing process validation: 1 year (Required)
  • biopharmaceutical plants: 1 year (Preferred)

License/Certification:

  • EU Passport (Required)
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Deadline: 10-05-2024

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