QA Validation Expert (Pharma/GMP)

On behalf of our Pharmaceutical client in Neuchatel, we are looking for QA Validation Expert for a short term contract.

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.

Main Responsibilities:

• 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.

Required Skills and Qualifications:
* Education:

• Degree in a scientific field (pharmacy, biotechnology, chemistry, or equivalent).

* Experience:

• 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).

* Personal skills:

• 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

Job Benefits:

• Opportunity to work in a leading pharmaceutical company, ensuring the development of technical and regulatory expertise.
• Involvement in critical projects for product quality and adherence to international standards.

Contact: Elaine Kanwar

Tel: +41 61 282 22 23