Principal – QA Validation
Roslin CT US Holdings,LLC•Hopkinton, MA
•$130,000 - $160,000
About The Position
The Principal, QA - Validation is responsible for providing QA oversight of validation activities in support of facilities and equipment validation activities. This includes supporting review and approval of new validation deliverables, governing procedures and training content, as well as supporting maintenance and optimization of facilities and equipment. The ideal candidate has extensive Quality Assurance experience in a GMP environment and experience in Validation in accordance with GAMP.
Requirements
- 8+ years relevant Quality Assurance experience in a pharma/biotech company, working within a Quality System and regulated GMP environment. Cell therapy experience a plus
- 3+ years Validation QA experience.
- Prior experience with implementing quality systems and/or continuous improvement initiatives focused on quality systems
- Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
- Ability to work independently to meet objectives and timelines
- Ability to make decisions of moderate complexity independently and escalate complex decisions as needed.
- Understanding of cGMP and ICH regulations/guidelines
Nice To Haves
- Cell therapy experience
Responsibilities
- Review and approval of deliverables such as validation plans, user requirements, risk assessments, testing scripts, requirements tracing, and validation summary reports.
- Support review and approved of executed protocols
- Support investigation and remediation of protocol discrepancies
- Review/Approve Deviations, Change Controls and CAPA(s), and related records
- Support ongoing maintenance and upgrades to existing systems and utilities
- Support periodic review of equipment and utilities
- Support the evaluation of systems for compliance with 21 CFR Part 11 and Annex 11.
- Support site Data Integrity initiatives
- Support implementation and QA training for new systems (as applicable)
- Mentor personnel within QA and cross functionally to promote compliance and quality culture
- Support Health Authority Inspections and Client Audits including audit responses and CAPAs
Benefits
- flexible and empowering work environment
- attractive benefits package
- emphasis on work-life balance
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
No Education Listed
