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Principal Scientific Associate - PSA-IDO-2021-2766
看过: 183
更新日: 25-03-2024
位置: Pratteln Basel-Landschaft BL
类别: 教育/培训
水平: Director
工作类型: Full-time
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工作内容
- Salary: 0.1k
- REF Number: 00051564
- Consultant: Adrien Guimard
- Contact: 0041 (0) 800 106 106
- Date Published: 03.09.2021
- Sector: Basel Area
- Location: PRATTELN, Experienced
- Discipline: Science - Analytical Chemistry
Main Responsibilities
- Organization of laboratoryactivities. Follow the processes defined in Guidelines and SOP’s
- Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content
- Write-up of analyticalmethods for implementation
- Participation and collaboration in meetings at intra- and inter-departmental level(e.g., CMC)
- Conduct of release, retest, stability studies, transfer and validation analyses
- Proper documentation of all analytical activities according to Good Documentation Practices
- Review, interpretation and documentation of analytical data
- Write-up and review of analytical protocols, reports and specifications
- Assurance of adequate maintenance and operation of analytical equipment according to GMP
- Drafting and review of CoAs and Analytical results sheets, specs ,SOPs, GUIs, TPLs and FRMs
- Organization of GMP-(re)qualification and validation of analytical equipment with external companies
- Elaboration ofqualification plans and review of qualification documents
- Training of Laboratory personnel on advanced tasks and GMP regulations
- Independently designs and executes projects or experiments with hands on involvement
- Independently reviews scientific work in project related activities
- Ensures availability of adequate lab materials and justifies acquisition of new materials or equipment
- Ensuring of cleanliness of laboratory and workspace
- Contact for 3rd parties, e.g., CMOs and CROs for defined analytical tasks
- Independent evaluation and development of novel analytical techniques and instrumentation
- Leverages workload of respective project members to assure timelines and budget are met
- Review CMC sections for INDP/IMPD and NDA/MAA filings
- Design and perform laboratory work to support product or process troubleshooting, special investigations, CAPA and product complaints with minimal supervision
- Set and accomplishproduct development timelines working closely with formulation scientist
- Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemicalengineering
- Apprenticeship 11+ years, BS 9+ years or MS 6+ years or PHD 0-2 years ‘experience
- Ability to efficiently plan and effectively execute and document analytical experiments in a GMP-compliant pharmaceutical environment
- Good knowledge of analytical chemistry with advanced knowledge of sample preparation, HPLC and spectroscopic instrumentation
- Good trouble-shooting skills for analytical analyses
- Good knowledge of GMP
- Ability to work independently and to take initiative
- Should actively seek for technical solutions to improve quality and productivity
- Proficient in English
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最后期限: 09-05-2024
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