Method Validation and Method Transfer Specialist

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Company Description

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

The Method Validation and Method Transfer Specialistwill play a crucial role in the validation, verification, and transfer of analytical methods within the company. The ideal candidate will have substantial experience in analytical method validation/verification in the pharmaceutical industry and a strong understanding of Compendial and ICH requirements. This position requires basic knowledge of statistics and the ability to manage a diverse portfolio of activities including planning, resource estimation, risk identification, decision making, communication, and team leadership.

Key Responsibilities:

• Conduct and oversee analytical method validation, verification, and transfer activities in accordance with regulatory guidelines and company standards.
• Ensure compliance with Compendial (USP, EP, JP) and ICH requirements for analytical methods.
• Develop and execute method validation protocols and reports.
• Perform statistical analysis and interpretation of validation data.
• Coordinate cross-functional teams to ensure timely and successful method transfers.
• Identify and mitigate risks associated with method validation and transfer activities.
• Plan, organize, and manage resources effectively to meet project timelines.
• Communicate project status, issues, and risks to stakeholders and senior management.
• Participate in internal and external audits and regulatory inspections.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 1 year of experience in analytical method validation/verification within the pharmaceutical industry.
• Experience with chromatographic techniques (HPLC, GC) and spectroscopic methods (UV, IR).
• Good knowledge of Compendial and ICH requirements.
• Familiarity with regulatory submission processes.
• Experience with Laboratory Information Management Systems (LIMS).
• Strong project management skills, including planning, resource estimation, and risk management.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong problem-solving skills.
• Proficiency in Microsoft Office Suite and relevant analytical software.
• Ability to communicate in both English and French.

Additional Information

• A full-time (40hours/week) Monday – Friday job.
• Job location: Braine l’alleud 50% and Lessines 50%
• A Permanent contract with flexible working hours.
• Work in a fast-growing international organization.
• Meal Vouchers 8 Euro/Working Day.
• Eco-Cheques +/- 250 Euro/Year.
• Company car + Fuel tank card.
• DKV Hospitalization insurance.
• Additional 12 ADV days.
• A company well-being program targeting both mental and physical well-being.
• 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.