Executive /Sr. Executive – CQA – Loan Licencing Shalina Healthcare

7.0 - 10.0 years

5 - 9 Lacs

palghar, vadodara

Work from Office

Monitoring of Loan Licence Site located in Palghar & Vadodara region. IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred Tablets, Capsules, Oral Powder formulations) Quality Oversight at Loan Licence Sites and tracking for closure of actions. FG Inspection, Review of batch records and Batch releases. Site pre-assessment for regulatory inspections as per GMP requirement. Investigation of any non-compliance in co-ordination with LLU Site and tracking closure of CAPA. Review and COA and analytical data before release of finished product from LLU Site. Review of Finished product related data to support new product Launch. Pr...

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Executive /Sr. Executive – CQA – Loan Licencing Shalina Healthcare

7.0 - 10.0 years

5 - 9 Lacs

navi mumbai, turbhe pawane

Work from Office

Monitoring of Loan Licence Site located in Navi Mumbai. IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred External preparations and Oral Liquid formulations) Quality Oversight at Loan Licence Sites and tracking for closure of actions. FG Inspection, Review of batch records and Batch releases. Site pre-assessment for regulatory inspections as per GMP requirement. Investigation of any non-compliance in co-ordination with LLU Site and tracking closure of CAPA. Review and COA and analytical data before release of finished product from LLU Site. Review of Finished product related data to support new product Launch. Process V...

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Executive/ Sr. Executive – CQA- Loan Licencing Shalina Healthcare

7.0 - 10.0 years

5 - 9 Lacs

navi mumbai, turbhe pawane

Work from Office

Monitoring of Contract manufacturers, Process Validation, Stability Study, Quality Agreement, APQR, FG Inspection and batch release. Responsible of co-ordination with regional representative to harmonize Quality systems across all LLU Sites. Quality Oversight at Contract manufacturing sites on periodic basis. Protocol preparation and execution of process validation for all dosage forms-Pharma. Stability Study and review of Stability Data as per stability interval. APQR preparation, Witness manufacturing and analysis of finished product. Execution of Quality agreements with all Contract manufacturing Sites. FG Inspection, Review of batch records and Batch releases Review of Finished product r...

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