Cadila Pharma

•	Follow cGMP and GLP PRACTICES.
•	To ensure current good laboratory compliance and ensuring all SOPs related to Quality Control laboratory are prepared and reviewed / implemented properly.
•	To follow safety Procedure in QC department.
•	To manage an accurate, reliable, efficient and timely review of finished products, in process/ validation, raw material, stability, GLP, Non-routine samples.
•	To ensure timely review of batch audit trail, system audit trail, message center.
•	To ensure review of Logbooks of instrument, equipment’s, columns, standards, impurities etc.
•	To review the COA of finished product in LIMS after the completion of analysis. 
•	To ensure the status label updated for the instruments, equipment, glassware and workplace.
•	To conduct the training program to analyst as per the training calendar. 
•	To ensure the training about the changes in standard operating procedures (SOP), if required.
•	To ensure the Sequence of HPLC/GC/IC are reviewed prior to start of the sample set.
•	 To ensure methods are prepared accordingly STP/SOP.
•	To ensure proper integration and reviewed prior to E- signature of data by reviewer
•	To ensure that the persons are working in the laboratory with proper compliance and follow the GMP & ALCOA+ Principle norms.
•	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 ensure timely closer of QMS related to Stability, Validation sample, Packing Material  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 Qualification of instrument problems.
•	To ensure the training about the changes in the standard operating procedure (SOP) if required.
•	To review and update the specifications as per pharmacopoeia and other regulatory requirements.
•	Responsible for all activities related to testing, approval and rejection of raw materials.
•	To perform  these activities in time bound manner as per regulatory requirements of different countries and bodies like ICH Guidelines, WHO and etc.
•       To receive raw material samples and checking of details of labels against sampling record.
•	 To receive vendor qualification samples and checking of details of labels.
•	 Distribution of work to the analyst as per production priority through LIMS.
•.	 To review and check raw data for completeness and correctness.
•.	 Review the result data in LIMS.
•	 To check & take print of the certificate of analysis from LIMS.
•	 To enter the result data of raw materials in LIMS.
•	 To performed timely released or reject of raw material in SAP.
•.	 To check master specification of raw material in LIMS and SAP.
•.	To prepare and check the SOP’s.
•.	Tracking of sending samples to outside testing laboratory.
•.	To issue continuation sheet to analyst if required.
•.	Provide COA to other department based on requirement.
•.	To review and approved QMS documents.

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