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Purpose - To perform Computer System Validation activities for the projects.

Position / Job Title - Assistant Manager

Department CQA – CSV

Reporting To CSV Head

Location Navi Mumbai

Years of Experience 8+ Year Experience

Job Responsibilities/ Deliverables

- Act as a CSV team for all validation projects for standalone, network instrument / Equipment’s and enterprise application
- Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met.
- Coach the implementation teams in the proper execution of validation documents.
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required.
- Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
- Develop / review CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, deliverables within the scope of the validation plan.
- Develop / review test plans, test scripts and user acceptance tests and manage the execution of test plans
- Execute or oversee the execution of validation plans and validation documents
- Perform project management activities for CSV process within the scope of the projects.
- Ensure initiation/preparation and closeout of all CSV related deviations,



discrepancies and change control documents.
- Work closely with stakeholders to ensure appropriate validation of cGMP computer systems.
- Conduct or facilitate CSV and 21 CFR Part 11 trainings
- Ensuring that all appropriate quality procedures are in place to support computer system validation
- Ensure that all computer system validation activities are carried out in accordance with approved procedure and protocols
- Monitoring compliance in accordance with regulations and established standards
- Approval of gap / risk assessment plan, assessment checklist, for GxP computerized system in accordance with regulatory guideline
- Review of all validation documents for accuracy, consistency and completeness.
- Co-ordinate with external vendors / service providers.
- Managing multiple site teams.
- Regulatory surveillance w.r.t CSV
- Update the CSV policies / procedures as per current regulation / regulatory update

Qualifications & Pre-Requisites

B.Sc., M.Sc., B. Pharm, Graduate in Computer Science

Additional notes • Will have to handle any other responsibilities if allocated.

- Having knowledge on Pharma process.
- Should have implementation/qualification/Validation knowledge and experience on QC and Manufacturing – Instrument / Equipment’s and enterprise applications.

📌 Assistant Manager (India)
🏢 Rubicon Research
📍 India