Arcadis Heist-op-den-Berg, Flemish Region, Belgium
Expert in Validation Analytical Lab
Arcadis Heist-op-den-Berg, Flemish Region, Belgium
2 days ago Be among the first 25 applicants
* 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
* Response 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
Experience:
* Master's or bachelor degree in chemistry/sciences/pharmaceutics or equivalent by experience.
* A minimum of 5 years’ experience in an Analytical Lab / METHODE TRANSFER.
* Experience in the creation of validation protocols, SOP’s, and preparation of validation reports.
* Experience with HPLC (experience on Waters system is a plus)
* 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.
* Good knowledge of Dutch and English language
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Science, and Production
Industries
Pharmaceutical Manufacturing
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