Job Description:
Sr. Executive (Tablet/Cap) 6-8 years w Preparation of Validation Master plan, Site Master File, Quality Manual.
* Preparation and Approval of Standard operating Procedures.
* Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data.
* To co-ordinate the Qualification / Validation of the Equipment, Systems and Process.
* To ensure the issuance of required documents and samples for Drug and Regulatory Affairs.
* To ensure the preparation, Issuance, Revision/Review and Retrieval of the documents.
* To investigate the cause of any non conformance and its corrective / preventive action.
* To ensure the Analytical method validation of cleaning process before conducting Cleaning validation.
* Preparation of Cleaning Validation Master plan.
* Preparation and Execution of Cleaning validation protocols.
* Cleaning Validation Analytical Data collection and Summary report preparation cleaning validation.
* To conduct or organise revalidation activity at the defined frequency.
* To control the inventory of control samples.
Officer/ Sr. Officer
(IPQA Tab/Cap) 2-5 years Over all IPQA activity (Tab/Cap) + Validation + Licensing work (FDA)
Officer/ Sr. Officer
(Liquid IPQA + Validation) 2-4 years Over all IPQA activity (Liquid) + Validation
Sr. Executive (Tablet/Cap) 6-8 years w Preparation of Validation Master plan, Site Master File, Quality Manual.
* Preparation and Approval of Standard operating Procedures.
* Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data.
* To co-ordinate the Qualification / Validation of the Equipment, Systems and Process.
* To ensure the issuance of required documents and samples for Drug and Regulatory Affairs.
* To ensure the preparation, Issuance, Revision/Review and Retrieval of the documents.
* To investigate the cause of any non conformance and its corrective / preventive action.
* To ensure the Analytical method validation of cleaning process before conducting Cleaning validation.
* Preparation of Cleaning Validation Master plan.
* Preparation and Execution of Cleaning validation protocols.
* Cleaning Validation Analytical Data collection and Summary report preparation cleaning validation.
* To conduct or organise revalidation activity at the defined frequency.
* To control the inventory of control samples.
Officer/ Sr. Officer
(IPQA Tab/Cap) 2-5 years Over all IPQA activity (Tab/Cap) + Validation + Licensing work (FDA)
Officer/ Sr. Officer
(Liquid IPQA + Validation) 2-4 years Over all IPQA activity (Liquid) + Validation
Additional Information:
Experience: 4-8 yrs
Location: Baddi
Education: B.Pharm, M.Sc, any
Industry Type: Pharma/ Biotech/Clinical Research
Compensation: 2 - 6.5 lakhs/anum
Experience: 4-8 yrs
Location: Baddi
Education: B.Pharm, M.Sc, any
Industry Type: Pharma/ Biotech/Clinical Research
Compensation: 2 - 6.5 lakhs/anum
To Apply/Send your resume, rajneeshb@wockhardtin.com, rmalhari@wockhardtin.com
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