Overview
QA Validation Expert Jobs in Neuchâtel, Switzerland at Aristo Group
Title: QA Validation Expert
Company: Aristo Group
Location: Neuchâtel, Switzerland
The QA Validation Expert plays a key role in regulatory compliance and quality assurance for processes and equipment within a pharmaceutical industry operating under GMP (Good Manufacturing Practices). Working closely with technical teams, they ensure the review and approval of validation protocols to guarantee the safety, efficiency, and reliability of pharmaceutical products.
Job title: QA Validation Expert
Industry: Biotech
Skills: QA,Validation
Start of project: asap
Duration of the project : 12 months
Location: Neuenburg, Schweiz
Main Responsibilities:
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.).
Evaluate validation results to confirm that all requirements defined in the protocols are fully met.
Identify discrepancies and propose corrective actions when necessary.
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.
Required Skills and Qualifications:
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
Strong knowledge of GMP standards and international regulations (FDA, EMA, ICH).
Familiarity with risk management methodologies (Risk Assessment) and validation protocols (IQ, OQ, PQ).
Analytical mindset and attention to detail in document reviews.
Excellent communication skills to effectively collaborate with multidisciplinary teams.
Solution-oriented approach and ability to manage multiple projects under tight deadlines.
Oral and written skills in English and French, fluency is an asset
