Process Validation Expert
7 days ago
This is an exciting opportunity to work in a state-of-the-art facility.
- Perform process validation activities related to drug substance and drug products, through defined clinical and commercial stages.
- Execute process validation activities related to the implementation of process changes and new processes while exercising supervised judgement within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet Health Authority requirements.
Responsibilities:
- Develop, execute and finalise process validation protocols for Client's drug substance and drug products.
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
Requirements:
- Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectors.
- Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations.
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Validation Expert
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