Posted By
Sweta
Account Manager HR - Pharma, Life Sciences & Chemical at Spectrum Talent Management
Last Login: 14 September 2017
Posted in
SCM & Operations
Job Code
245210
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.
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Posted By
Sweta
Account Manager HR - Pharma, Life Sciences & Chemical at Spectrum Talent Management
Last Login: 14 September 2017
Posted in
SCM & Operations
Job Code
245210