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QA Validation Expert (M/F/D)
Tasks:
Review of validation protocols:
Assess validation protocols related to equipment, processes, CIP, SIP, computerized systems, and HVAC/Utilities.
Ensure compliance with GMP requirements, internal company standards, and international regulatory guidelines (FDA, EMA, etc.).
Validation report review:
Evaluate validation results to confirm that all requirements defined in the protocols are fully met.
Identify discrepancies and propose corrective actions when necessary.
Quality support:
Collaborate closely with technical departments (Production, Engineering, Validation, etc.) to foster an integrated quality approach.
Participate in project meetings and provide expertise on quality aspects related to validations.
Qualification:
Degree in a scientific field (pharmacy, biotechnology, chemistry, or equivalent).
Significant experience (2 years or more) in a similar role within the pharmaceutical industry, in a GMP environment.
Expertise in process, equipment, CIP, SIP, computerized systems validation
Experience in filling line, freeze-dryer validation is a plus
Technical skills:
Strong knowledge of GMP standards and international regulations (FDA, EMA, ICH).
Familiarity with risk management methodologies (Risk Assessment) and validation protocols (IQ, OQ, PQ).
Oral and written skills in English and French, fluency is an asset
Requirements:
Start: asap
Duration: 2 months
Capacity: 5 days per week
Location: Greater Neuchatel Area
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