Quality Assurance Validation
Quality Assurance Validation
Posted on :
16-07-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.
- Provide QA oversight for periodic review and requalification program.
- Perform review of CMMS records related to asset management including asset release database requests and work orders.
- Author and perform review of SOPs in Veeva.
- Review and approve validation protocols and reports (IQ OQ PQ CSV process validation cleaning validationEnsure compliance of validation activities with applicable GMP regulations industry guidance and internal SOPs.
- Collaborate with cross-functional teams (Validation QA Engineering Manufacturing QC) to support timely execution of validation projects.
- Participate in change control assessments risk assessments and deviation investigations related to validation.
- Provide QA input during validation planning and execution phases.
- Support audits and regulatory inspections by providing validation documentation and addressing QA-related inquiries.
- Ensure data integrity and documentation accuracy in all validation records.
- Requirements :
- Bachelors degree in a technical discipline with 5 years validation and/or quality assurance experience. In lieu of degree 7 years of equivalent work experience is required.
- Knowledge of 21 CFR ICH EU Regulations GAMP 5 risk-based validation.
- Prior experience working in cell and gene therapy manufacturing preferred.
- Prior experience working with contract manufacturing preferred.
- Experience with Kneat strongly preferred.
- Applies collaborative approach to problem solving and is experienced with risk-based decision making.
- Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.
Employment Type
Full-time
Key Skills
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