Support of Lab Equipment Validation HPLC & UPLC
- Contract Type
Areas of responsibilities are :
- Qualification of lab equipment devices GC, HPLC & UPLC on waters
- Need to be able to set up and write a validation protocol, to analyze the validation results, provide a conclusion and write validation report.
- Develop and/or review departmental documentation including training, SOP's, change controls, deviations and CAPA’s (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines.
- Provide analytical and microbiological technical expertise in pharmacopeia tests, regulatory requirements, changes, investigations and root cause analysis.
- Share successes with other departments during report out sessions with management.
- Organize and lead project meetings. Attend daily communication.
- Work according to applicable safety guidelines.
- Response to internal & external enquiries
Specific requirements (skills) or experience for the assignment:
- Master degree in chemistry/sciences/pharmaceutics or equivalent by experience.
- A minimum of 1-year experience with equipment validation.
- Experience in the creation of validation protocols, SOP’s, and preparation of validation reports.
- Must: Experience with HPLC & UPLC on Waters systems
- Knowledge of Empower (navigation system of HPLC devices of water)
- 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 the ability to work independently and to work in global cross-functional project teams.
- Proactive attitude, taking the 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 creative 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 the Dutch and English language
Extra info achtergrond:
In departement 3 afdelingen:
Calibratie: onderhoud+ productietesten (analytisch =dossering, oplossnelheid tablet + microbio testings)+ondersteuning leveranciers, Q doc schrijven, wijzigingen Q doc aanbrengen;
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