218 Jobs in Gujrat - Page 2

Production : To check the labels of raw material, packing materials and solvents before usage. To maintain storage conditions of raw material/intermediates in plant. To maintain process conditions for batch as per BPRs. To take instruction from shift Incharge/managers for batch charging / monitoring & follow up. To report any deviation / discrepancy in plant / process to shift in charge. To complete given task within stipulated time. To maintain environment conditions in PP/Intermediate area as per SOP To maintain reconciliation of accessories used in PP/Intermediate area. To ensure that there is no any contamination in finished product To do packing & repacking activities as per requirement To follow proper entry & gowning procedure in PP/Intermediate area To perform safe operations of plant equipments and utilities. Documentation : To complete online BPR, equipment usage record & cleaning records with respect to his shift. To fill area differential pressure record, centrifuge bags records and any other records related to PP area. cGMP : To guide & train workmen in Finished Powder Processing Section. To ensure that yield & quality of finished product is as per predefined norms. Packing of finished product is as per SOP. Responsible for maintaining cleanliness of the equipments and area under his charge To do proper calibrations of weighing balance, pH meter etc. as per SOP. To update equipment status boards timely. To ensure on line completion of equipment usage log. To maintain proper labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. To fill online documentation/BPR. To participate in training to keep himself updated about cGMP, technical and safety standards and update his training records timely. To maintain intermediate product & cleaning material reconciliation. Safety : To keep himself aware about MSDS of related materials. To educate and supervise plant operators in safe handling of chemicals and equipment so as to prevent accidents To coordinate with EHS for various safety permits. To use scrubber wherever required to avoid air pollution. Wastage Avoidance / Reduction : To ensure no spillage of solvents & wastage of material. To close the valves of utilities supplies when not required. Inter departmental co-ordination : To coordinate with QC department for getting analysis report. To coordinate with Engg Service for maintenance related work in his shift.

To maintain and adherence of the GLP and safety procedures in laboratory. To raise the request for issuance of work data sheet / protocols. To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation. To maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis of In-process, finished products & returned goods / Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head. To ensure that every specification and method of analysis used of right product/material code. To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries and results are in line with current specifications and STPs. To ensure column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge. Joint analysis with R&D personnel during analytical method transfer on HPLC. To perform analysis of stability samples as per stability schedule Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. Inform and Investigate OOS results in Finish /stability study. Initiation of change control / deviations / NQI / QI/OOT related to QC.

Maintain employee life cycle data from starting to end in GEMS/HRIS and update the same as required time to time. To provide training Employee of CSBU employees and New Joiners. Providing ID card of New Joiners Updation/correction of attendance, leave of employees on daily basis as & when required. Preparation/issue of absenteeism letter to employee as & when required to keep control on regular attendance. Checking attendance and salary inputs of employee on monthly basis and handover to payroll for final processing of salary. Entry of overtime and canteen related deduction in HRIS monthly basis. Responsible for Upload and deposit of PF Challan before 15th of every month. Helping employee's in their Name, DOB, Father Name correction through portal /PF office. Responsible for addition of new join employees in company PF A/c. Helping employees in Withdrawal and transfer of their PF fund Compliance as per PF act.(KYC, Aadhar card, PAN card and Bank A/c update in PF) Maintaining good liaison with PF office. Intimation of Hospitalization for Reimbursement claim process and sending document to TPA for claim process. Helping Employee's in Medical claim related issues. Yearly/Monthly Correction, Edition and Deletion of employee details in GMI. To ensure smooth and speedy full and final settlement of employees and arrange exit interview with HR head for finding out areas of improvement. Registration of Apprentice through BOAT and State Government. Upload Quarterly Assessment of BOAT apprentice on BOAT portal. Apply for Apprentice reimbursement to BOAT and State Government. Conducting Practical Exam of Trade apprentice as per new government rule and submit the exam attendance sheet and practical numbers to trade apprentice advisor office. Maintain compliance as per apprentice act. Participating in CFTs meeting of the Plant and address HR related issue/concern as required. Carryout any other assignments given by Superior time to time.

Review of analytical data of scale up and validation batches, commercial batches of finished products and also of raw materials, packing material, in process, intermediate, hold time study, stability study and working standard. Review of system audit trail and review of electronic data (Comparison of hard copy and soft copy) To ensure the every analysis is to be performed as per predefined approved / current version of specification and method of analysis. To ensure that all the analysis as per customer specification is done (for dispatch) as per the planning (planning to be taken as per delivery instruction) and ensure all dispatches in time with all documentation. Monitor and Maintain records of Training, analyst validation and competency. To ensure all records / documents are maintained in compliance to regulatory requirements. To ensure all the entries, records and results are in line with current specifications and STPs and review and approval of reviewed certificate of analysis for raw, packing material / intermediate and APIs. Ensure daily on-line entry in SAP and LIMS modules. Review of outside laboratory certificate of analysis. Ensure CFR 21 part -11 compliance and good chromatography practices followed during analysis, & review for proper of chromatographic analysis to maintain proper data integrity Ensure that all documents / records required for Regulatory Compliance are maintained properly. Review SOP's for regulatory compliance and actual practice. Ensure timey report and completion of NQI, OOS, OOT, deviation, customer / market investigation and change control. Ensure all issues related to completed batches are resolved and documents are transferred to QA. To revise the SOP/STP as per schedule To maintain instruments logbooks properly as per analysis. To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively. To review the Standard Operating procedures, work sheets/protocols of Hold time / stability / validation / qualification and other relevant documents of Quality control department. To co-ordinate with QA department for cGLP system To co-ordinate with production department for on line analysis To co-ordinate with production department for planning/clubbing of analysis. To co-ordinate with store department to prior information of urgent analysis of raw material. Prepare and submit reports as required. To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents.

Production : To check the labels of raw material, packing materials and solvents before usage. To maintain storage conditions of raw material/intermediates in plant. To maintain process conditions for batch as per BPRs. To take instruction from shift Incharge/managers for batch charging / monitoring & follow up. To report any deviation / discrepancy in plant / process to shift in charge. To complete given task within stipulated time. To maintain environment conditions in PP/Intermediate area as per SOP To maintain reconciliation of accessories used in PP/Intermediate area. To ensure that there is no any contamination in finished product To do packing & repacking activities as per requirement To follow proper entry & gowning procedure in PP/Intermediate area To perform safe operations of plant equipments and utilities. Documentation : To complete online BPR, equipment usage record & cleaning records with respect to his shift. To fill area differential pressure record, centrifuge bags records and any other records related to PP area. cGMP : To guide & train workmen in Finished Powder Processing Section. To ensure that yield & quality of finished product is as per predefined norms. Packing of finished product is as per SOP. Responsible for maintaining cleanliness of the equipments and area under his charge To do proper calibrations of weighing balance, pH meter etc. as per SOP. To update equipment status boards timely. To ensure on line completion of equipment usage log. To maintain proper labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing.

To maintain and adherence of the GLP and safety procedures in laboratory. To raise the request for issuance of work data sheet / protocols. To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation. To maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis of In-process, finished products & returned goods / Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head. To ensure that every specification and method of analysis used of right product/material code. To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries and results are in line with current specifications and STPs. To ensure column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge.

Production : Supervision of production & maintenance activities of respective shift. To ensure that every raw material used is of right quality (approved from QC, having reference Number) and quantity (verifying the weights, if required by re weighing) in every batch To ensure 100% implementation of process conditions for batch as per BPRs. To take instruction from managers for batch charging / monitoring & to execute. To ensure maximum utilization of plant equipment & manpower in respective shift To report any deviation / discrepancy in plant / process to his to reporting manager. To ensure completion of batches as per plan. To do SAP transaction related to production module. Documentation : To ensure to have online completion documents with respect to his shift. To check critical operation with respect to BPR and to verify the related document. Quality : To ensure that instructions in BPRs are followed judiciously To ensure Intermediates / FP produced is as per quality specification To guide / train workmen / trainees / contract workmen in Finished Powder Processing Section. To ensure very high standards of housekeeping in plants and FP areas. cGMP : To ensure proper calibrations of pH meters & weighing balance as per SOP. To ensure timely updation of equipment status board Ensure BPRs of ongoing batches are available at specified places near equipment and are online with production To ensure on line completion of equipment usage log & documentation. To ensure labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. Safety : To ensure awareness to MSDS To educate / train / supervise workmen / Trainees / contract workmen in safe handling of chemicals and equipment so as to prevent accidents To ensure the operators are aware / trained in usage of PPE To coordinate with EHS for various safety permits Wastage Avoidance / Reduction : To ensure no spillage of solvents & wastage of material. To ensure closing of valves for utilities supplies when not required (cross check when operation is complete) Switching of reactor and plant lamps when not required Training : To train operators & subordinate on Safety / Quality / wastage reduction To guide / train workmen / trainees in Finished Powder Processing Section. Inter departmental co-ordination : To coordinate with QA department for Good Document Practice. To coordinate with QC department for getting analysis report. To coordinate with Engg Service for maintenance related work. To coordinate with EHS for safety and environment related issues. To coordinate with HR for Manpower related issues.

Handling of Document Cell. Issuance & Control of Quality documents like BPR, Specification, Analytical method protocol, SOPs, Hard book, Product label and formats. Review of BPR & analytical documents. PQR Preparation. IPQA Monitoring and Line clearance. Handling of Change control, Deviation, OOS, OOT, CAPA, Failure investigations, NCR. Preparation & Review of Master documents. Handling of finished product release dispatch activity. Review of Validation /Qualification protocol and Report. Documentation support to RA and Marketing. Any work related to QA as and when required.

To maintain and adherence of the GLP and safety procedures in laboratory. To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis. To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head. To ensure that every specification and method of analysis used of right product/material code. To follow the instruction of Shift /Section In charge for analysis /planning. To report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries, and results are in line with current specifications and STPs. To ensure the all column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge. To maintain reference / working standard/impurity standard usage records. To maintain instrument history record. Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC. Preparation of stability protocols and stability reports. To perform analysis of stability samples as per stability schedule Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. Perform holding time study of intermediates and preparation of reports. Inform and Investigate OOS results in RM/Intermediates/APIs Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to Maintain proper data integrity. To ensure no spillage of lab. Chemicals / solvents To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents. To coordinate with store department to prior information of urgent analysis of raw material.

To maintain and adherence of the GLP and safety procedures in laboratory. To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis. To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head. To ensure that every specification and method of analysis used of right product/material code. To follow the instruction of Shift /Section In charge for analysis /planning. To report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries, and results are in line with current specifications and STPs. To ensure the all column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge. To maintain reference / working standard/impurity standard usage records. To maintain instrument history record. Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC. Preparation of stability protocols and stability reports. Toperformanalysis of stability samples as per stabilityschedule Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. Perform holding time study of intermediates and preparation of reports. Inform and Investigate OOS results inRM/Intermediates/APIs Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to Maintain proper data integrity. To ensure no spillage of lab. Chemicals / solvents To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents. To coordinate with store department to prior information of urgent analysis of raw material.

Production : To check the labels of raw material, packing materials and solvents before usage. To maintain storage conditions of raw material/intermediates in plant. To maintain process conditions for batch as per BPRs. To take instruction from shift Incharge/managers for batch charging / monitoring & follow up. To report any deviation / discrepancy in plant / process to shift in charge. To complete given task within stipulated time. To maintain environment conditions in PP/Intermediate area as per SOP To maintain reconciliation of accessories used in PP/Intermediate area. To ensure that there is no any contamination in finished product To do packing & repacking activities as per requirement To follow proper entry & gowning procedure in PP/Intermediate area To perform safe operations of plant equipments and utilities. Documentation : To complete online BPR, equipment usage record & cleaning records with respect to his shift. To fill area differential pressure record, centrifuge bags records and any other records related to PP area. cGMP : To guide & train workmen in Finished Powder Processing Section. To ensure that yield & quality of finished product is as per predefined norms. Packing of finished product is as per SOP. Responsible for maintaining cleanliness of the equipments and area under his charge. To do proper calibrations of weighing balance etc. as per SOP. To update equipment status boards timely. To ensure on line completion of equipment usage log. To maintain proper labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. To fill online documentation/BPR. To participate in training to keep himself updated about cGMP, technical and safety standards and update his training records timely. To maintain intermediate product & cleaning material reconciliation. Safety : To keep himself aware about MSDS of related materials. To educate and supervise plant operators in safe handling of chemicals and equipment so as to prevent accidents To coordinate with EHS for various safety permits. To use scrubber wherever required to avoid air pollution. Wastage Avoidance / Reduction : To ensure no spillage of solvents & wastage of material. To close the valves of utilities supplies when not required. Inter departmental co-ordination : To coordinate with QC department for getting analysis report. To coordinate with Engg Service for maintenance related work in his shift.

To maintain and adherence of the GLP and safety procedures in laboratory. To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis. To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head. To ensure that every specification and method of analysis used of right product/material code. To follow the instruction of Shift /Section In charge for analysis /planning. To report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries, and results are in line with current specifications and STPs. To ensure the all column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge. To maintain reference / working standard/impurity standard usage records. To maintain instrument history record. Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC. Preparation of stability protocols and stability reports. To perform analysis of stability samples as per stability schedule Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. Perform holding time study of intermediates and preparation of reports. Inform and Investigate OOS results in RM/Intermediates/APIs Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to Maintain proper data integrity. To ensure no spillage of lab. Chemicals / solvents To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents. To coordinate with store department to prior information of urgent analysis of raw material.

Preventive Maintenance : Preventive maintenance of the equipment's is as per checklist and instruction / Feedback from SectionIncharge. Prepare preventive Maintenance Checklist for all the plant. Check the I.M.T.E (Instrument Measuring Testing Equipment's) as per direction of Head... Breakdown Maintenance Minimize the breakdown time of equipment or system by, Attending the breakdown as early as possible after receiving the job card. (Intimation of breakdown). Evaluate the reasons behind the breakdown and find out he appropriate remedies. Take instructions from Executives and execute them. Fulfill the safety requirement permission from plant. After completion of job, ensure that the place is neat and clean. Energy Conservation Continues co-ordination with Plant people for minimizing the energy losses by creating awareness of the losses. Safety Check the interlocks of systems. Ensure that all jobs are done by issuing right safety permit and after completions of job it shall properly closed. Inter departmental co ordination Any modification in existing system shall co-ordinate with Production & QA department. Coordination for availability of spares and inform to superior. Documentation To prepare USFDA, all regulatory audits, ISO, system documentation with proper record. To prepare of cGMP documentation & proper record of the same. To ensure compliance regulatory documents & proper record of the same.

Budgeting & Manpower Planning Preparing and reviewing the Head Count & Labour Cost budget for the year considering business need, after discussion with various stakeholders with an objective of optimum utilization of resources. Finalize the organization structure to support the business for current and future requirements. Responsible for headcount forecast . Selecting Talent to the business To ensure all open positions are filled up as per Manpower planning, for each department and approved by the management. Prepare organization chart by end of every month & submit it to Corporate HR. Review & verify JD's for new & existing employees in line with business requirement. Policy & Process implementation Provide inputs to Systems Group in designing relevant HR Policies, and also help in evolving location specific policies. Train the employees on SOP compliance & review, work on Audit findings. Single point of contact to Business Be the single reference point for all HR areas of the Business. Work in an integrated role of an HR Manager, spanning across all areas of HR for business. Participate in various meetings of CSBU and ensure the HR issues are properly addressed for the business. Responsible for implementation of all HR programs & initiatives in the Location department/division. Talent Management and Development Induct employees though appropriate induction mechanism as per organization SOP, and strive for constantly improving the quality of induction Play a key role in Talent identification, development and retention Uundertake employee engagement in identifying interventions that motivate employees, make Cadila a Great Place to work. Address employee grievances on time. Initiate Individual development Plan for employees and identify relevant programs viz. Job rotation, Training and on the job training in discussion with business heads. Review training needs of all category employees, through feedback form employees, HOD's and performance appraisals. Review Training calendar for next year. Ensure to impart training to various categories of employees with proper evaluation. Organizational Development Initiatives. Leading change initiatives in own area and supporting continuous improvement in the plant. Ensuring Organizational Health surveys are conducted in the plant. Analyzing results of survey and areas of improvement highlighted by the results of the survey. Putting them forth for discussion with the team and developing action plans. Communicating results to all members in the plant. Allocating responsibilities and resources, if required for meeting business need. Building and maintaining a culture of continuous improvement to make Cadila, a better place to work. Employee Relation Interact Union committee regularly for smooth employee relationship & resolve union issues and employee grievances amicably Take disciplinary actions in order to maintain discipline in plant Review court cases, minimize it and ensure effective strategy, resolve/settle in proactive manner in company favour for smooth employee relationship. To interact with advocates on regular basis for effective handling court cases. To carry out productivity based settlements on the site /group of company. Budgeting & Controlling To prepare HR & Admin. Budget pertaining to Revenue & Capex on yearly basis. To ensure that all expenses strictly remain in budget through maintaining effectivity of the department functions. Statutory Compliances /Legal Ensuring full complaince with statutory laws for Unit-I & Unit-2 & review the status in Legatrix System (CATS) Clearly communicating impact on operations in case of non-compliances to all departments Liaisoning with government officials and local authorities Ensuring timely and accurate updation and maintenance of all statutory records Coordinating inspections at plant Performance Management System: For new calendar year, based on Business Goals & Goals & Action plan of Unit Head, to set Goals & Action Plan for all employees in the month of December. Ensure to get complete mid-year review of goals for all category employees by given time line. Prepare performance sheet and send consolidated sheet with ratings of individual employees for Increment Exercise. Based on performance ratings to counsel employees for higher performance. Initiate performance management activities annual, Midterm and ensure to timely completion. Initiate PIP in the respective Location/department/division.

Delivery & Financial Achievement : Responsible to deliver the allocated annual budget and achieving the PBT target of CSBU. To propose FG supply plan & ensure supplies as per agreed demand on Daily/weekly/monthly/yearly basis. Ensuring availability of right first time quality material month by month to achieve the planned & agreed monthly targets /Sales. Compliance Management : To ensure EHS compliance round the clock in order to achieve zero accident target for manufacturing sites. cGMP compliance by 24X7 of Unit-I & Unit-2 to meet regulatory agencies requirements. Ensuring to comply statutory task of manufacturing units as per CATS tracker to achieve 100% compliance under various laws. Ensure for developing safety culture through trainings and various initiatives in plants. Operational Excellence & Cost Reduction : To be in line with the yearly budgeted norms and target and achieve the Top Line & Bottom Line month on month basis. To ensure proper utilizations of plant capacities, debottleneck to improve on capacities & workout collaborative manufacturing options. Introduction of New Products : To support B&PE for implementation of Cost Reduction Plans & new products scale ups, validations. Quality Management : Ensure quality product manufacturing Right First Time at site to meet customers specifications and market demand. Cost Management & Lowest Cost Productions : To advise/guide to all functions in a cost effective manner and to ensure cost reduction wherever possible. Capex Implementation within Budget & Timeline : Propose the CAPEX plan for approval & ensure the CAPEX expert & project within budget & Timeline. Implementation of approved proposal capacity enhancement, facilities creation plans for upcoming growing business requirement. Timely upgrdation of the facility to ensure cGMP compliance.

Production : To receive crude solvents from plants and issue recovered solvents to plants. To check the labels of raw material, packing materials and solvents before usage. Perform column distillation as per SDR. To maintain process conditions for batch as per SDRs. To maintain storage conditions of raw material/solvents in plant. To take instruction from superior for batch charging / monitoring & follow up. To report any deviation / discrepancy in plant / process to seniors. To complete given task within stipulated time. To maintain environment conditions in Plant as per SOP. To perform safe operations of plant equipments and utilities. To store solvents in proper condition in drums and tanks whatever is applicable. Documentation : To complete online SDR, equipment usage record & cleaning records with respect to his shift. cGMP : To ensure that yield & quality of solvents is as per predefined norms. Packing of solvents as per SOP. Responsible for maintaining cleanliness of the equipments and area under his charge To update equipment status boards timely. To ensure on line completion of equipment usage log. To maintain proper labeling of HDPE / GI drums, hose pipes etc. used in respective batch processing. To participate in training to keep himself updated about cGMP, technical and safety standards and update his training records timely. To maintain reconciliation of solvents.

Production : To check the labels of raw material, packing materials and solvents before usage. To maintain storage conditions of raw material/intermediates in plant. To maintain process conditions for batch as per BPRs. To take instruction from shift Incharge/managers for batch charging / monitoring & follow up. To report any deviation / discrepancy in plant / process to shift in charge. To complete given task within stipulated time. To maintain environment conditions in PP/Intermediate area as per SOP To maintain reconciliation of accessories used in PP/Intermediate area. To ensure that there is no any contamination in finished product To do packing & repacking activities as per requirement To follow proper entry & gowning procedure in PP/Intermediate area To perform safe operations of plant equipments and utilities. Documentation : To complete online BPR, equipment usage record & cleaning records with respect to his shift. To fill area differential pressure record, centrifuge bags records and any other records related to PP area. cGMP : To guide & train workmen in Finished Powder Processing Section. To ensure that yield & quality of finished product is as per predefined norms. Packing of finished product is as per SOP. Responsible for maintaining cleanliness of the equipments and area under his charge To do proper calibrations of weighing balance, pH meter etc. as per SOP. To update equipment status boards timely. To ensure on line completion of equipment usage log. To maintain proper labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. To fill online documentation/BPR.

Security : Implementing stringent security measures for protecting man, material, information and high-value assets of the organization and conducting timely security audits. Deployment of security personnel Promoting physical security and safety awareness for managers, employees and contractors through the development and delivery of presentations and information, addressing physical security issues, Crisis Management and Business Continuity. Implementing security SOP and policies. Ensure preparedness to meet any emergency situation. Review emergency response plan time to time. Vigilance & Investigation of theft / fraud cases. Manage the administration of security personnel & security overhead expenses. To ensure all statutory records are kept and updated properly. Training, Development, welfare and motivation of security personnel. Regular visits and night checking of locations. Monitoring of returnable Goods gate passes. Regular liaison with local law enforcement agencies. Admin: Responsible for strategic utilization and deployment of available resources to achieve the organizational objectives. Formulation, review and effective implementation of Admin policies. Upkeep & Maintenance of premises with proper Housekeeping, pest control etc. Responsible for managing Fax, post & courier, telephones and pool cars. Management of Garden, landscaping of the campus and Horticulture staff. Foreign delegates and Visitors management. Manage and plan office space / work station / seating arrangement. Supervision of Reception & Tele operators, canteen facility and KAKABA Hospital. Facility, vendor / services providers management, Planning and implementation of policies vis- -vis administrative issues. Conceptualization and successful execution of day-to-day operational & administrative tasks. Providing efficient and effective support in administrative functions. Ensure contractual, legal and statutory compliances in respect of Admin. MIS and controlling Admin budget. Organize customized training programme based on the training need analysis to enhance the manpower skills & efficiency of Admin and utility personnel. Explore / Implement various options for controlling overhead admin expenses. Responsible for contract Management Budget & MIS : On annual basis support HR Head for preparing HR Expenses Budget. MIS and controlling Admin budget. Liaison with Police Department and other authorities : To maintain good relationship with Police Department and other authorities for ensuring smooth administration functioning.

Prepare Daily MIS (Sales, Production, Order & Expenses). To support MPP-2, MPP-3 & MPP-4 plant for finance related matters. To prepare Plant wise expenses. Booking of Import Material Bills & CHA Expenses and prepare Import Register. To assist Plant Finance & Corporate Finance for Statutory Audit & Cost Audit. To prepare Stock Valuation for Raw Material, Packing Material, Work in progress, Finished Goods & Engineering Items. Stock statement with details of Finish Goods, Work in progress, Raw materials, Packing Material and other purchase of materials for the month. To ensure timely delivery of goods to all (domestic & export) Customers within the defined credit limit & giving information to concern person for the same. Support to HOD for calculation of Product Cost on monthly & YTD basis. Any other work assigned by Corporate Finance.

Supervision of production & maintenance activities of respective shift. To ensure that every raw material used is of right quality (approved from QC, having reference Number) and quantity (verifying the weights, if required by re weighing) in every batch. To ensure 100% implementation of process conditions for batch as per BPRs. To take instruction from managers for batch charging / monitoring & to execute. To ensure maximum utilization of plant equipment & manpower in respective shift. To report any deviation / discrepancy in plant / process to his to reporting manager. To ensure completion of batches as per plan. To do SAP transaction related to production module. Documentation : To ensure to have online completion documents with respect to his shift. To check critical operation with respect to BPR and to verify the related document. cGMP : To perform verification of pH meters & weighing balance as per SOP. To ensure timely updation of equipment status board Ensure BPRs of ongoing batches are available at specified places near equipment and are online with production. To ensure on line completion of equipment usage log & documentation. To ensure labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. cGMP : To perform verification of pH meters & weighing balance as per SOP. To ensure timely updation of equipment status board

Documentation: To prepare SOP's/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice. Ensure that all documents / records required for Regulatory Compliance are maintained properly. Ensure old records are archived properly and are retrievable. To check online filling of document & online submission to QA department. Raise change control/ Deviation/ CAPA in OASIS LIMS. To support SAP transaction in production module as & when required. Raise indents for Consumables, parts, Stationary and Spares required for the plant. To ensure for high standards of housekeeping in plants. To maintain all records and documents as per GDP/SOPs. To take lead in audit preparedness and report to factory manager in case of any deviation. To maintain training records of employees in respect of training SOP. Production : To perform the role of production officer/executive as and when required. Cross Functional Department: To coordinate with QA, department for compliance. To coordinate with QC, PD Lab, Engineering and HR etc. for GMP Compliance. To coordinate with EHS for safety and environment related audits.

To maintain and adherence of the GLP and safety procedures in laboratory. To raise the request for issuance of work data sheet / protocols. To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation. To maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis of In-process, finished products & returned goods / Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head. To ensure that every specification and method of analysis used of right product/material code. To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries and results are in line with current specifications and STPs. To ensure column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge.

To maintain and adherence of the GLP and safety procedures in laboratory. To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis. To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head. To ensure that every specification and method of analysis used of right product/material code. To follow the instruction of Shift /Section In charge for analysis /planning. To report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation. Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. To record and ensure all the entries, and results are in line with current specifications and STPs. To ensure the all column performance and column entry are maintain in column logbooks. To maintain instruments log books properly as per analysis. To acquire training from concerned person to update the cGMP system update technical knowledge. To maintain reference / working standard/impurity standard usage records. To maintain instrument history record. Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC. Preparation of stability protocols and stability reports. Toperformanalysis of stability samples as per stabilityschedule Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. Perform holding time study of intermediates and preparation of reports. Inform and Investigate OOS results inRM/Intermediates/APIs Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to Maintain proper data integrity. To ensure no spillage of lab. Chemicals / solvents To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents. To coordinate with store department to prior information of urgent analysis of raw material.

To coordinates of project documentation such as Engineering drawings, Equipment specifications. To monitor status of project to ensure documentation is submitted according to schedule. To review and verifies project documents for completeness, format and compliance with URS. To submit project documentation to management for approval and transmits approved documents to QA. To confer with Engineers, Managers, User and others to discuss project, prepare documents. To execute the report of DQ/IQ/OQ/PQ as per site condition. To ensure and perform Qualification of Equipments as per cGMP norms and as per time schedule. To perform and ensure online documentation. To coordinate with vendors for certificates, drawings and other equipments related documents. To ensure and verification of Utility validation and its documentation online. To prepare MOM during installation and commissioning of equipments at site by vendors. To invite, conduct Equipments operational training of user, Engineering, Project team after successfully commissioned of Equipments. To physically check the Equipment which is installed at site for preparation of Qualification document.

Maintenance Services : To distribute the daily work to maintenance officer of respective plant & ensure timely compliance. To co-ordinate with electrical, instrument and Utility sectional head for routine/critical maintenance activities. To communicate and maintain check list of mechanical activities & preventive maintenance as per schedule. To proper communication with project department for plant modification and building maintenance work. To prepare daily / monthly/equipment uptime maintenance report. To review & ensure timely compliance of plant maintenance & Utility services to plant operation. To evaluate the breakdown of the equipment's by failure analysis & implementation of corrective & preventive measures For Technical Problem & Supporting for engineering activities supposed to visit on Unit-II. To maintain the housekeeping work and scrap removal from plant to scrap yard as per process. Coordination with Sectional head Electrical & Instrument on daily basis for maintenance related activities. Energy Conservation To inspect the functioning of equipments regularly to avoid malfunctioning & energy loss. To ensure the optimization usage of resources for reduction of waste. To ensure & timely rectification of leakages / spillages to save energy. Safety To comply & maintain the safety guidelines & procedures in the maintenance function. To ensure & maintain the safety interlocks & guarding of mechanical system. To comply and maintain the statutory inspection with records.