CSV Validation Engineer (Pune)

CSV Validation Engineer (Pune)

13 Aug
|
Cleanstep Pharma And Engineering Solutions
|
Pune

13 Aug

Cleanstep Pharma And Engineering Solutions

Pune

Roles and Responsibilities

- Conduct CSV activities such as Risk assessment, Gap analysis, and validation planning.

- Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11.

- Ensure compliance with EU Annexure 11 requirements for software validation.

- Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems.

- Develop test scripts and execute tests using V-model approach.

- Preparation, Execution, Compilation and approval of below documents (Not limited to)
- 1) User requirement specifications
- 2) Validation Plan
- 3) GxP Assessment
- 4) System Design Specification
- 5) Risk Assessment
- 6) Network (Infra) Qualification
- 7) Installation Qualification protocol
- 8) Operational Qualification
- 9) Performance Qualification
- 10) Traceability matrix
- 11) Validation summary report

📌 CSV Validation Engineer (Pune)
🏢 Cleanstep Pharma And Engineering Solutions
📍 Pune

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