Laboratory Analyst

Role Summary

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

Responsibilities

• Conduct and supervise analytical method validation, verification and transfer activities in accordance with regulatory guidelines and company standards.
• Ensure compliance with pharmacopoeia (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 method transfer in a timely and successful manner.
• Identify and mitigate risks associated with method validation and transfer activities.
• Plan, organize and manage resources effectively to meet project deadlines.
• Communicate project status, issues and risks to stakeholders and management.
• Participate in internal and external audits and regulatory inspections.

Requirements

• The ideal candidate must have a master's degree in chemistry, biochemistry, pharmaceutical sciences or a similar field.
• At least 1 year of experience in validation/verification of analytical methods in the pharmaceutical industry.
• Experience with chromatographic techniques (HPLC, GC) and spectroscopic methods (UV, IR).
• Good knowledge of pharmacopoeia and ICH requirements.
• Knowledge of 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.
• Attention to detail and strong problem-solving skills.
• Proficiency in the Microsoft Office suite and relevant analysis software.
• Perfect command of French is essential. An intermediate level of English is required.

Benefits

• Full-time employment (40 hours/week) Monday to Friday.
• Permanent contract with flexible hours (start possible between 7:00 a.m. and 9:30 a.m.).
• Workplace: Bd René Branquart 80, 7860 Lessines.
• Meal vouchers 8 euros/working day.
• Eco-checks +/- 250 euros/year.
• DKV hospitalization insurance.
• 12 additional days of leave.
• Don't have enough legal days off? We have the solution.
• A corporate wellness program focused on mental and physical well-being.
• Access to Payflip, an innovative application that helps you control and optimize your salary.
• A platform to consult dermatologists for any skin-related questions.
• A fantastic team with monthly lunches, fun team building activities (laser tag, escape rooms, sports, etc.) and above all, a great collaborative international working environment.
• Personal development through on-the-job learning and additional training.

About the Company

Eurofins PSS Insourcing Solutions® is an award-winning global insourcing solution. We deploy our skilled team directly to the client's site, where they manage operations smoothly and eliminate complexities. We guarantee a strategic, long-term commitment that delivers added value directly at the client's site, using their facilities, equipment and methodologies, while maintaining the same level of service, expertise and cGMP compliance as that offered at Eurofins facilities. If you are an employee looking for an exceptional career path, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration and success come together. Join us in a world where excellence knows no limits!