Assistant General Manager

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.