Emcure Pharmaceuticals Limited hiring Officer – QA (R&D)/ QA Analytical R&D at Pune, Maharashtra location
We Emcure Pharmaceuticals Limited hiring Officer – QA (R&D)/ QA Analytical R&D, Location of job will be Pune, Maharashtra, Minimm experince required to perform this job will be 2 to 5 years, interested can share cv @manojt.kumar@emcure.co.in
Job Description:
· Revision in Method of analysis (MOA) and specification due to Pharmacopoeia updates requiring method development / method changes, if any.
· Receipt of Technical Report, Inter office note, SOP’s, Drug substance specification, Drug product specification, Raw material specification, In-process specification and Method of Analysis.
· Initiation and Handling of change controls related to preparation / revision in specification, Method of Analysis, Standard test procedure, Standard operating procedure and related documents.
· Updation, revision and loading of specification in SAP system.
· Review of SAP generated specification.
· Preparation / revision and review of Drug substance specification, Drug product specification, Raw material specification, In-process specification, Method of Analysis, Standard test procedure and Standard operating procedure as per the requirement.
· Initiation of change control for change in SAP specification.
· Concurrence/ review of change implementation of change control forms as a designee of Department Head/Site QA.
· Issuance of documents to relevant sites (i.e. Specifications, MOA’s, STP’s and SOP’s).
· Initiation and review of Deviation, Discrepancy and Risk assessment reports.
· To ensure compliance to Ethical conduct and data integrity policy.
· Perform additional tasks as assigned by Team leader and Head of department to enhance quality system management, cGMP & compliance.
Interested can share cv @manojt.kumar@emcure.co.in
