Description :

- Responsible for all activities related to Stability, Validation samples, PM & QC at Dholka plant. - To ensure current positive 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

📌 Assistant General Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka