PSC Biotech is a leading Biotech Consultancy firm seeking a Sr QA Validation Associate to support quality oversight of validation activities in a GMP regulated environment.
Requirements
- Key Subject Matter Expert (SME) and Quality Oversight representative in specific validation discipline(s)
- Maintains current knowledge of industry standards and regulatory requirements for validation techniques / approaches utilized
- Supports the QA Validation group in maintaining regulatory compliance, in line with industry best-practices in specific validation discipline(s)
- Supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise
- Supports strategy development and ensures regulatory compliance for validation projects
- Provision of mentorship and SME support to more junior members of the QA Validation team and cross functional groups as applicable
- Lead and represent QA Validation in multi-departmental meetings & project teams
- Identifies and leads implementation of improvements to validation systems
- Quality Oversight for Validation execution activities related to the various validation disciplines
- Supports development of validation plans for specific system implementation projects
- Establishes site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures
- Provide Quality Oversight for any assigned change requests, deviations, quality events and associated CAPAs
Benefits
- Employee Value Proposition
- permanent contract of employment
- Learning & Development in-house training mentorship through constant guidance to facilitate career progression
