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QA Reviewer - CSV Consultant
Job Summary:
We are seeking a meticulous and knowledgeable QA Reviewer with expertise in Computer System Validation (CSV) to join our Quality Assurance team of experts. The ideal candidate will have a strong background in reviewing and ensuring the compliance of computer systems used in pharmaceutical operations. This role is critical in maintaining the integrity and reliability of our systems in accordance with regulatory requirements.
Key Responsibilities:
- Review and approve CSV documentation, including validation plans, protocols, reports, and test scripts.
- Ensure all computer systems comply with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards.
- Conduct thorough reviews of user requirements, functional specifications, and design documents to ensure completeness and accuracy.
- Collaborate with cross-functional teams, including IT, Quality, Manufacturing, and R&D, to ensure validation activities meet quality standards.
- Perform risk assessments and impact analyses to determine the validation approach for new and existing systems.
- Provide expert guidance on CSV best practices and regulatory expectations to project teams.
- Participate in internal and external audits and inspections, providing expertise on CSV-related matters.
- Stay updated with industry trends, regulatory changes, and advancements in computer system validation.
- Assist in the development and maintenance of CSV policies and procedures.
Qualifications:
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in computer system validation within the pharmaceutical or biotech industry.
- Strong understanding of regulatory requirements and guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
- In-depth knowledge of GxP principles and their application to computer systems.
- Excellent attention to detail and analytical skills.
- Strong communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in project management and organizational skills.
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