Analytical Method Validation Specialist

SmartRecruiters, Inc.; Sint-Katelijne-Waver; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

40 hours / week

Permanent contract with flexible hours

Wavre, Belgium

Eco-Cheques 250€ / year

12 ADV days

Well-being program

Payflip access

Team lunches and teambuilding

Professional development

Résumé du poste

Eurofins PSS Insourcing Solutions® seeks an experienced Analytical Method Validation Specialist to support QC Operations in a pharmaceutical manufacturing setting. You will coordinate validation activities, author validation documentation, and ensure GMP compliance while driving improvement projects.

You'll collaborate with laboratory teams, statisticians, and project stakeholders, providing quality systems support and ensuring ongoing validated state of analytical methods in a dynamic,

Qualifications

• Master’s degree in chemistry, biochemistry, pharmaceutical sciences, biotechnology or related field.
• Minimum 1.5 years of experience in pharmaceutical Quality Control, Analytical Development, Validation, or Quality Assurance.
• Strong experience with analytical method validation in a GMP-regulated environment.
• Experience authoring technical and validation documentation.
• Experience with Change control, Deviation Management and CAPA management.
• Fluent English; French is a plus.

Responsabilités

• Author and maintain validation-related documentation (protocols, reports, amendments, risk assessments, etc.).
• Coordinate validation activities across multiple stakeholders.
• Support quality events linked to validation activities (deviations, CC, CAPA).
• Participate in peer review and quality review of validation documentation.
• Contribute to maintaining validated state of analytical methods and support continuous improvement.

Connaissances

English fluency

Formation

Master’s degree in chemistry / Biochemistry / Pharmaceutical Sciences / Biotechnology (or related)

Description du poste

Eurofins PSS Insourcing Solutions®is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client' site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!

Job Description

We are seeking an experiencedAnalytical Method Validation Specialistto support Quality Control (QC) Operations within a leading pharmaceutical manufacturing environment. The successful candidate will be responsible for coordinating and authoring analytical method validation activities, ensuring compliance with GMP requirements and supporting continuous improvement initiatives.

This role offers the opportunity to work closely with laboratory teams, statisticians, quality representatives, and project stakeholders while contributing to critical validation projects and quality excellence programs.

Key Responsibilities

Analytical Method Validation Documentation

• Author and maintain validation-related documentation including:
  • Validation protocols
  • Validation reports
  • Amendments
  • Risk assessments
  • Scientific rationale reports
  • Technical instructions
  • Periodic review documentation
  • Raw data review documentation
  • Comparability protocols and reports
  • QC material qualification documentation

Validation Project Coordination

• Coordinate validation activities across multiple stakeholders.
• Collaborate with laboratories, project teams, quality representatives, and statisticians.
• Monitor validation studies and experimental progress.
• Coordinate pre-tests, validation studies, data collection, and reporting activities.
• Analyze validation results and ensure appropriate documentation of outcomes.

Quality Systems Support

• Support and coordinate quality events linked to validation activities, including:
  • Deviations
  • Change Controls (CC)
  • Corrective and Preventive Actions (CAPA)
• Participate in investigations and associated meetings.
• Ensure compliance with internal quality systems and GMP expectations.

Review & Compliance Activities

• Participate in peer review and quality review of validation documentation.
• Contribute to maintaining the validated state of analytical methods.
• Support risk-based decision making for method lifecycle management.
• Participate in operational excellence and continuous improvement projects within QC Operations.
• Identify opportunities to enhance validation processes, documentation quality, and operational efficiency.

Qualifications

• Master’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related scientific discipline.
• Minimum 1.5years of experience in pharmaceutical Quality Control, Analytical Development, Validation, or Quality Assurance.
• Strong experience with analytical method validation in a GMP-regulated environment.
• Experience authoring technical and validation documentation.
• Experience with Change control, Deviation Management and CAPA management.
• Fluent communication skills in English. French is a plus.

Additional Information

• A full-time (40hours/week) Monday - Friday job.
• A Permanent contract with flexible working hours. (Can start between 7am and 9:30am)
• Place of work: Wavre, Belgium.
• Eco-Cheques +/- 250 Euro/Year.
• Additional 12 ADV days.
• A company well-being program targeting both mental and physical well-being.
• Access to Payflip,an innovative app that helps you take control and optimize your paycheck.
• A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment
• Personal development through learning on the job and additional trainings.
• And more.