2.0 - 3.0 years

2 - 3 Lacs

tarapur

Work from Office

Role & responsibilities 1. Responsible for issuance and retrieval of batch production & control record (BPCR) through EDMS 2. Review of batch production & control record (BPCR) 3. To perform incubation, withdrawal and reconciliation activity of stability 4. To ensure & execute retention samples are handled as per the SOP 5. To maintain records of daily monitoring temperature & humidity of stability chamber. 6. To perform annual product quality review. 7. To perform CSV validation as per SOP 8. Applying approved labels to all approved finished products. Preferred candidate profile Bulk drug & API Industry candidate preferred.

Posted 3 weeks ago

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CSV Validation Engineer Cleanstep Pharma And Engineering Solutions

2.0 - 7.0 years

3 - 8 Lacs

Hyderabad, Pune, Mumbai (All Areas)

Work from Office

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 (I...

Posted 3 months ago

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