Qa Qc Engineer

Education :B.TECH/B.E.;Chemical

Experience :1-10 Years

Industry :Chemical

Work Time

Salary : -1 /- Per Month

Incentive

Language Known :

Phone : +9198********

Email : ****@*****.com

Website : www.******.com

Job Description :GREETINGS FROM SHRI KRISHNA PLACEMENT!!! We are looking for a senior QC profile who shall be based at Khambhat, Dist Anand. Experience : minimum 2.5 Yrs Salary : Not a constraint for right candidate JOB DESCRIPTION ROLES & RESPONSIBLITIES: Ensuring sampling and complete analysis of Raw material, Finished product, In process samples etc. IQ,OR, PR investigation preparation, review of BMR, BPR, SOP, STP, Specification, Method Validation and Transfer Protocols Ensuring stocks of primary standards, working standards etc & records the same. familiar with cGMP, ISO requirements, Data Integrity, Document Cell, Batch release process, Trending APR shop floor Operation in API / Bulk Drug Checking and review of QC SOPs., Specifications, Protocols. Attending various external suppliers / vendors. Manufacturing. Implementation of new changes incorporate. Data Integrity - Responsible to review of HPLC and GC , QC Sop Compliances, Investigation activities , OOS and OOT and quality control instruments. Must have experience of handling team. Document Cell -Review of documents before submissions, distribution / Issuance of BMRs, Master Formulae, SOPs and Formats to the respective departments and controlling all master documents. Calibration of instruments like HPLC, GC, LCMS. Responsible for Raw Material Sampling, analysis of in process samples, FP, Stability Samples Batch Release - Knowledge of ICH guidelines and should review of BMRs and Validation documents and to give usage decision and dispatch Method Development for testing 1) New Products 2) RM 3) WIP Technology transfer documents - Review R&D process & TTD, evaluation of CPP & CQA and comparison with batch record , review of master batch record also review of specification and STP of API, Intermediate, RM, In-process. Identify Impurities or Impurity profiling Trending and APR - Knowledge of Market complaint, Deviation, Incident, Change control for trending of Systems, Review of Master SOPs, BMRs, PCRs, validation Protocols and reports and Annual Review reports. NOTE : WE ARE NOT CHARGING TO THE CANDIDATES INTRESTED CANDIDATE CAN SEND CV ON [email protected] And can also call on 8488855343