establish system as per requirements of cGMP / Statutory / Regulatory . review the stability reports ensuring the retest / expiry dates of the API'S and Intermediates. review of analytical data for reliability / compliance w.r.t. CFR part-11 in QC
Qualification :- B.Sc or M.Sc Place of Posting :- Sotonala, Behror, Rajasthan. No of Open Position :- 10 3. Production :- API Plant Exp :- 5 to 10 Years Qualification :- B.Sc, M.Sc, B.Tech Place of Posting :- Sotonala, Behror, Rajasthan. No of Open Position :- 10
Responsible for handling Change controls. (Evaluation, Impact review, Implementation and Verification of closure of change control). Responsible for handling of Deviations Responsible for handling Out of Specification in Raw materials, Intermediates and Finished products results. To coordinate in the execution of Scale-up, process validation Activity. (Preparation and review of Scale-up study and Process ...
* Issuance & retrieval of the BMR, BCR, BPR & all control documents * Preparation of APQR * Exposure to Handling of Validation / Qualification / Change control / Deviation / OOS and Market complaints * Records as per cGMP / Regulatory requirements * Preparation of records/documents as assigned by the senior in QA departments * Preparation of QA SOP and any other documents work relevant to department. * Sampling/sealing of ...
8Roles: Gravimetry, Volumetry,AA, GC, HPLC, FTIR, PH-meter, K.F, IR, UV-VIS, Calibrationinstruments, TLC.3) QA documentation 3 to 6 yrs. Sal 1.8 to 3 lacs. positions-2Roles: Planning internal Audits, SOP'S, calibration's, APR reviews, preparing/ reviewing validating protocal and reports, checking and approving. BPCR's, checking
* Issuance & retrieval of the BMR, BCR, BPR & all control documents * Preparation of APQR * Exposure to Handling of Validation / Qualification / Change control / Deviation / OOS and Market complaints * records as per cGMP / Regulatory requirements
Strong PERL programming skills; C++& JAVA Must possess 'Quality mindset'; knowledge of testing and test automation methodology Experience on cloud technology, cloud based platform & services is plus (AWS, Azure, Google, OpenStack etc.) Experience with REST APIs Knowledge of Agile Practices, CICD