Job Title: Clinical Systems Validation Analyst (CSV Analyst)
Job Location: Trivandrum (Onsite)
Job Timing: Standard shift (9.30am – 6.30pm IST)
Company Name: Flex and Oncology Clinical Research Pvt Ltd, (Acquired by Worldwide Clinical Trials)
RESPONSIBILITIES:
Tasks may include but are not limited to:
Tasks may include but are not limited to:
- Author computer system validation documentation
- Author Change controls for computer systems including
- Perform Risk and Impact Analysis
- Identify impacted computing resources, processes, and documentation
- Plan with Subject Mater Experts the expected delivery dates for activities
- Approval and review of test plans, test cases, and test scripts to ensure completeness and traceability to requirements
- Manage change activities through to change closure
- Catalogue and track project-specific validation documentation
- Review of non-worldwide qualification and validation documentation to ensure completeness and traceability to Worldwide requirements
- Tracking periodic review activities, including but not limited to disaster recovery and access reviews
- Responsible for collating and reporting metrics
- Responsible for preparing materials for Worldwide audits
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- KNOWLEDGE OF GxP REGULATIONS
- FDA 21 CFR Part 11 for Electronic Records and Electronic Signatures
- FDA Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (Guidance for Industry)
- GAMP 5 Second Edition
- EMA Guideline on computerised systems and electronic data in clinical trials
- EMA Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
- Ability to communicate concisely and effectively in both written and spoken English
- Problem Solving and Relationship Management skills
- Proficient in the use of common office software Self-motivated individual who can positively contribute to a team environment
- Ability to prioritize and handle multiple projects simultaneously
- Ability to demonstrate attention to detail
REQUIREMENTS:
- College degree in a relevant discipline (Computing / Scientific) or able to demonstrate equivalent experience
- At least 2 years’ experience working in a role performing testing or compliance.
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Experience of document authorship and control
- Experience of working within organizations employing GAMP, GxP, ISO standards.
- Experience in pharmaceutical industry, CRO, Clinical or Lab experience, or other highly regulated industry preferred
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Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations preferred