QA Validation Expert

Job description:

Location: Neuchâtel

Contract Type: Contract

Duration: Until 31/05/2025 (extension possible)

Start Date: ASAP

Workload: 100% (Onsite)

Requirements:

• Review validation protocols for equipment, processes, CIP, SIP, computerized systems, and HVAC/utilities.
• Ensure validation activities comply with GMP, internal standards, and international regulatory guidelines (FDA, EMA, ICH).
• Review validation reports, assess results, and propose corrective actions when required.
• Collaborate with technical departments (Production, Engineering, Validation) to ensure an integrated quality approach.
• Participate in project meetings, providing quality and compliance expertise.

Competences:

Education:

• Degree in pharmacy, biotechnology, chemistry, or a related scientific field.

Experience:

• Minimum 2 years of experience in a similar role within the pharmaceutical industry under GMP regulations.
• Expertise in process, equipment, CIP, SIP, and computerized systems validation.
• Experience with filling line and freeze-dryer validation is a plus.

Skills:

• Solid knowledge of GMP standards and international regulations (FDA, EMA, ICH).
• Proficient in risk management methodologies and validation protocols (IQ, OQ, PQ).
• Analytical and detail-oriented, with strong documentation and reporting skills.
• Solution-oriented and able to manage multiple projects under tight deadlines.
• Fluent in English and French (both oral and written).

Compensation benefits:

• A key role supporting quality assurance and regulatory compliance in a leading pharmaceutical company.
• Involvement in high-impact validation projects.
• Opportunity to further develop technical and regulatory expertise in a dynamic environment.