Assistant General ManagerJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBAssistant General Manager
Cadila Pharmaceuticals Ltd
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Posted: 09 Jul 26
Job Description
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.
Job Particulars
Role head quality
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2921242
Job Category Quality Control
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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