4 Ooc Jobs

Responsible for maintaining GLP and GDP in QC department. Review of SOPs, Specifications and STPs. Identifying training needs of the staff in the QC department. Ensuring that all Analytical Instruments are in good working condition Ensure and maintain AMC / Calibration / Qualification schedule and status of QC Instruments / Standard Weight and other measuring instrument and timely completion of the same as per the schedule. Up keeping the laboratory all the time ready for regulatory and customer audits. Responsible for QC QMS Activity i.e Lab Incident, Deviation, OOS, OOC, CAPA for their timely initiation, investigation and closer. Compliance for maintaining Working Standard and Reference Standard in the lab. Ensure and verification of Log Books / Analytical Documents and online documentation in the lab. Compliance for Columns / Chemical / Volumetric Solution / Reagent Solution management Compliance for Instrument Tags / Labels/ QC Status Board / NABL analysis Responsible for maintaining and continuous improvement as per ICH Q7 A and relevant regulatory guidelines. Ensuring a safe environment is maintained in the laboratory. Regularly provide the training to the QC Colleagues on SOP, GMP and GLP. Ensure the Analytical Method validations as well method transfers are conducted with an approved protocol and duly documented and approved. Present GLP and GMP related activities in the weekly review meeting and monthly review meeting to the Senior management. Regularly supporting and providing the data as per the requirement from customer and regulatory. Develop & prepare work procedures to minimize OHS risks and Adverse Environmental Impact. Involve the regulatory and customer audits to provide the answers for queries Ensure the data integrity checks are conducted regularly to evaluate the health of the Quality system and implement actions as required. Control and issuance of loose formats and hard books. Preparation and review of Standard Operation Procedures, Specification, Test method and Quality control procedures. Responsible for review and release of batches-QC analytical Documents. Responsible for approval and release of products for Dispatch. As and when additional responsibilities arise, same shall be taken based on the requirement. Qualifications BSC / MSC / B Pharmacy / M Pharmacy

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA / Production / PPIC / Warehouse / TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Qualifications Bachler degree

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelor's degree