Beschreibung
Validation Expert vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- Practical knowledge in manufacturing science and technology or technical development coupled with strong understanding of manufacturing processes and related process equipment
- Profound background in process validation including know-how in reviewing and writing technical reports with Work experience in cross-functional project management
- Familiarity with standard pharmaceutical analytical testing as well as competency of quality systems and regulatory requirements
- University degree in pharmacy, chemistry or related field
- Languages: fluent English both written and spoken
Your tasks:
- Elaborating risk assessments for validation, ensuring validation activities adhere to current requirements and cGMP along with handling deviations including monitoring pre-validation and validation
- Reviewing and editing process, packaging or cleaning validation protocols or related reports, suggesting MBRs and associated change controls as well as providing support for the execution at the shop floor
- Translating critical process parameters and the process control strategy into a focused validation plan for process validation as well as contributing, reviewing and revising any SOPs related to validation activities
- Providing technical expertise, training and support to new associates, improving and adjusting the product improvement portfolio and ensuring documents are in line with requirements and industry standards by offering input to Quality Manuals, Quality Directives, global Standard Operating Procedures and Guidance Documents
- Writing and maintaining Validation Master Plan for process, cleaning and packaging validation as well as defining local procedures and templates for respective validation processes, documentation and validation master plan
- Supporting the strategy for continued process verification and monitoring batches that ensure all critical process parameters as well as quality attributes are defined after validation activities
Start:
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH14407
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