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Senior CQV Engineer
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Full-time
- Provide quality support and oversight (approval) of process and equipment validation and change control records and activities,
- Review documentation (e.g. validation records/reports, change control records, periodic reviews, etc.)
- Effectively engage with team members within the organization and third party manufacturer (TPM) teams, and
- Perform quality oversight & approval of equipment, process, and validation documentation and change control records (e.g. pFMEAs, URSes protocols, reports, SOPs, work instructions, process flow diagrams, ECs, etc.)
- Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g., work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities)
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