Responsibilities Coordinating with Engineering department for preventive and break down maintenance, modifications etc. Purchase for procuring and controlling auxiliaries. Quality operations for all quality related matters. Performing the function related to SAP activities. Coordination with packaging department for bulk availability.   Qualification & Experience B. Pharm / M. Pharm from reputed university 2 to 3 years in pharmaceutical manufacturing (Preferably in Granulation , compression & Coating section)  

Responsibilities In the Preparation and review of ANDA for US Submission for oral solid dosage form (Tablet & Capsule) /Parenteral formulation. Should have knowledge of eCTD format for US/Europe and other regulatory agencies. Responding to the ANDA deficiency. Review of CMC section of drug substance for ANDA submission. Submission of Post-approval changes (viz. PAS, CBE-0, CBE-30). Review of Bioequivalence study protocol and report. Submission of Annual report/PADER to FDA. Knowledge in eCTD software & also have knowledge of DMF.  

Responsibilities Line Clearance and shop floor complianc Assisting in Complaint Investigation system at site Assisting in Qualification and validation system, change control system, deviations Preparing & review the Annual Product Quality Review Review of Batch Manufacturing & Packing Records Coordination of cGMP Training activity. Compliance Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes Review of protocols for qualification and validation of facility/ equipment / product / process Review of validation reports after execution of validation of facility /equipment / product / process   Qualification & Experience B. Pharm / M. Pharm from reputed university 3 to 5 years similar experience in regulatory approved OSD manufacturing large unit.  

Responsibilities Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples. Performing analysis of Stability, process validation samples, Cleaning Validation. Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Preparing SOPs and Formats and Analytical Test Record. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data related to testing activity. Preparing protocol for Analytical Method validation, cleaning validation and performing the validation exercise as per the protocol. Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material. Coordinating with production, and warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.   Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.   Qualification & Experience M.sc (Organic / Analytical Chemistry) with 1-4 years of Experience as an analyst in similar industry GMP & GLP knowledge Good coordination & communication skills.  

Responsibilities Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples. Performing analysis of Stability, process validation samples, Cleaning Validation. Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Preparing SOPs and Formats and Analytical Test Record. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data related to testing activity. Preparing protocol for Analytical Method validation, cleaning validation and performing the validation exercise as per the protocol. Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material. Coordinating with production, and warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.   Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.   Qualification & Experience M.sc (Organic / Analytical Chemistry) with 1-4 years of Experience as an analyst in similar industry GMP & GLP knowledge Good coordination & communication skills.  

Responsibilities Analysis Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples. Performing analysis of Stability, process validation samples, Cleaning Validation. Good Laboratory Practice Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Preparing SOPs and Formats and Analytical Test Record. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data related to testing activity. Validation Preparing protocol for Analytical Method validation, cleaning validation and performing the validation exercise as per the protocol. Management of laboratory Consumables Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material. Coordinating with production, and warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.   Qualification & Experience M.sc (Organic / Analytical Chemistry) with 1-4 years of Experience as an analyst in similar industry GMP & GLP knowledge Good coordination & communication skills.  

Responsibilities Management of Export and Import for Zentiva India limited. Responsible for Management of Export of goods from Site to Customers and importation of Raw material from vendors. Management of licensing for pertaining to movement of goods and regulatory compliance. Management of logistic activities and manage the distribution cost at optimal level. Handling and managing and developing team for management of EXIM activity from Ankleshwar Site. Support customer service role by ensuring dispatch of domestic and Export finished goods including management of priorities set by the market supply chain. Responsible to manage warehouse activities at Pharmaceuticals and Chemical Warehouse Ankleshwar, related to packing, raw and finished goods material ensuring optimum stock level Effective utilization of resources, adhering to global warehousing standard and HSE requirement, to fulfil the customer’s requirement. Review and maintain process for material requiring special storage requirement as per law. Receipt, Issue and dispatch To ensure receipts of RM and PM from the vendors and to ensure issuance of RM and PM to production and managing the material flow as per the SOP. Timely management of obsolete materials and the rejected materials. Perform blind count of stocks as per the SOP, on monthly basis. To ensure updating the products with new MRP as per the notification from Finance.   Qualification & Experience M. Pharm / B. Pharma with Minimum 8-10 years of similar profile experience in any big Pharmaceuticals or Chemicals industries.