Responsible for all activities related to Stability, Validation samples, PM & QC at Dholka plant. • To ensure current good laboratory compliances and ensuring all SOPs related to quality control laboratory are prepared and reviewed / implemented properly. • To manage an accurate, reliable, efficient and timely testing function of stability samples. • To ensure that the persons are working in the laboratory with proper compliance and follow the GMP & ALCOA+ Principle norms. • To ensure timely withdrawal of stability sample and plan accordingly. • To ensure timely release of Stability, Validation sample, Packing Material & Penicillin Lab in order to avoid delay in delivery of goods. • To ensure timely regulatory & audit compliance related to Stability sample along with effectiveness. • To ensure that only trained & Qualified and authorized personnel are in working on respective working area. To carry out review and suggest periodic training, wherever required. • To investigate and file change control, deviation, out of Specification (OOS), out of trend (OOT) report and Laboratory events whenever observed. • To ensure timely closer of QMS related to Stability, Validation sample, Packing Material & Penicillin Lab along with root cause and CAPA. • To review the Specification/STP and to update them from time to time if required. • To communicate the regulatory, technical and quality information to all the concerned. • To ensure the Instrument Breakdown/Qualification/Calibration/Preventive maintenance timely rectification of instrument problems. • To ensure the training about the changes in the standard operating procedure (SOP) if required. • To ensure accurate document preparation / review procedures being carried out relating to stability samples as per the regulatory norms, checking / monitoring them and issue of certificate of analysis to various departments. • To initiate, review and implement the change control wherever necessary after getting it approved from HOD. • To monitor the activities for stability study protocol / reports to provide the support to regulatory for stability data and document submission. • To ensure proper functioning of all instruments / reducing instrument idle time / preventive maintenance, annual maintenance / calibration of instruments (In-house) or (outside) and monitoring from time to time. • To review and update the specifications as per pharmacopoeia and other regulatory requirements. • Participation in quality review team. • Any other work assigned by HOD. • Follow cGMP and GLP practices in Microbiology lab- Main pharma QC laboratory. • To analyze the Sample of RM, Validation, FP, in process, Stability for Microbiological analysis by respective specification and SOP. • To follow safety Procedure in Microbiology laboratory (Main Pharma-QC) • To attend the training as per schedule. • To receive the samples for analysis and making entry in Inward register. • To maintain the Instruments log books related to sample analysis. • To analyze the sample and compilation of documents. • Preparation and sterilization of media for analysis. • Used media destruction as per respective SOP. • Responsible for cleaning & monitoring of laboratory. • Responsible for online documentation. • Sampling and Microbiological/ chemical testing of Purified water, Water for injection, Potable water samples and pure steam condensate samples. • Plate / Tube verification and release and on-line data recording • Work allocation and distribution • To ensure the training about the changes in standard operating procedures (SOP), if required. • Review of analytical data • Change control, master document preparation and review • Regulatory Audits and Periodic self-inspection • Do any other Work assign by HOD. • Follow cGMP and GLP practices in Microbiology lab-Penicillin QC • To analyze the Sample of RM, Validation, FP, in process, Stability for Microbiological analysis by respective specification and SOP. • To follow safety Procedure in Microbiology laboratory (Penicillin QC) • To attend the training as per schedule. • To receive the samples for analysis and making entry in Inward register. • To maintain the Instruments log books related to sample analysis. • To analyze the sample and compilation of documents. • Preparation and sterilization of media for analysis. • Used media destruction as per respective SOP. • Responsible for cleaning & monitoring of laboratory. • Responsible for online documentation. • Sampling and Microbiological/ chemical testing of Purified water, Water for injection, Potable water samples and pure steam condensate samples. • Plate / Tube verification and release and on-line data recording • Work allocation and distribution • To ensure the training about the changes in standard operating procedures (SOP), if required. • Review of analytical data • Change control, master document preparation and review • Regulatory Audits and Periodic self-inspection • Do any other Work assign by HOD.
