DGM - Quality Control - Pharma

Exposure to regulatory audit is a must

Experience : 15-20 years

Experience in Pharma - Formulation Industry.

- Audit management, Team management, coordination and tasking and delegation.

- Handle various wings of Quality control departments like Formulation, Active Pharmaceutical Ingredient, Stability and Process development Quality Control.

- Handled the Documentation activity for preparation of Standard Operating Procedure, preparation of specification, Method of analysis, Protocol preparation, control of protocol and distribution of protocols.

- Documentation and Exposure of Change Control, Deviation and Internal training.

- To Investigate of LIR and maintain of OOS and OOT Records.

- Investigation of Market Complain and prepared its compliance Reports.

- Wide Knowledge of Method development of API, intermediate stage, solid and liquid doges form on different instrument like HPLC, GC, UV etc.

- Knowledge of Method transfer and Method Verification from ADL to Plant and other Countries.

- Knowledge of different formulation product in form of solid and liquid Dosage, Coated and ER/PR tablets, Hard and soft Gelatin capsule, Syrup, Injection and dry powder.

- Audit preparation like WHO, TGA, MCA, USFDA, ANVISA, ISO etc.

- Exposure in Internal Audit and external and preparation of audit report

- To control data management and Maintain audit trail of different instruments.

- Exposure in Stability sample study analysis as per ICH guidelines and maintain its records.

- Investigation of OOS, OOT, and Deviations.