Description:
Areas of responsibilities are :
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 :
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.
Compendial review: Assess compendial changes, perform method verification, training of analysts
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 Specific requirements (skills) or experience for the assignment?
Education + experience :
Master''s (preferably) or bachelor degree in chemistry/sciences/pharmaceutics or equivalent by experience.
Experience in the creation of validation protocols, SOPs, and preparation of validation reports
Knowledge of Pharmacopeias (USP, Ph. Eur., JP)
Working knowledge of cGMP requirements.
Must haves :
A minimum of 2 years experience in an Analytical Lab.
Experience with HPLC (experience on Waters system)
Experience in method validation
Knowledge Empower Software
Personal skills :
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