Validation Expert Analytical Lab

Tasks:

• Validation of analytical methods & method transfer: need to be able to set up and write a validation protocol, to analyze the validation results, provide conclusion and write validation report

• Cleaning Validation: Sample preparation, HPLC analysis, processing of HPLC data with Empower software

• Compendial review: Assess compendial changes, perform method verification, training of analysts

• Annual review (reduced testing program): Data analysis + reporting

• Respond to internal & external enquiries

• Review data generated by other analysts of the team

• Develop and/or review departmental documentation including lab data sheets, training documentation, SOP's, change controls, deviations and CAPA (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines.

• Provide analytical technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis

• Share successes with other departments during report out session with management

• Organize and lead method transfer project meetings, attend conference calls

• Attend daily communication

• Work according to applicable safety guidelines

Skills:

• Master's or bachelor degree in chemistry/sciences/pharmaceutics or equivalent by experience.

• A minimum of 2 years’ experience in an Analytical Lab.

• Experience in the creation of validation protocols, SOP’s, and preparation of validation reports.

• Experience with HPLC (experience on Waters system is a plus) & Empower is a must

• Knowledge of Pharmacopeias (USP, Ph. Eur., JP)

• Working knowledge of cGMP requirements.

• Good verbal and written communication skills.

• Ability to work precisely and accurately.

• Team player with ability to work independently and to work in global cross-functional project teams.

• Proactive attitude, taking initiative to help drive the projects forward.

• Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.

• Strong demonstration of problem-solving skills. Open for innovation and proposal of new ideas. Have good creativity thinking skills.

• Ability to understand and extract necessary information from technical documents.

• Ability to effectively manage workload and prioritize activities. Ability to handle multiple tasks simultaneously and to meet critical milestones and goals.

• Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint.

• Good knowledge of Dutch and English language