Job Description Summary Responsible for Customs clearance of all Import & Export cargo under EOU/IGCR scheme. Job Description Job Description : Coordination within cross functional team, Customs broker, Freight forwarder, Customs authorities, Port authorities, Transporter to arrange international & domestic shipment delivery Preparing and filing of EOU statutory documents /returns with Customs and SEEPZ authorities Practical experience on preparing and filing of Monthly, Quarterly returns online in IGCR portal, Preparing and filing of APR returns with SEEPZ and E-way bill Good communication and negotiation skills with awareness of MS Excel and Pivot table Education & Experience : Graduate, with practical 4 to 5 years working experience in Logistics/Exim in EOU unit, especially in Pharma Industry.
Job Description Summary The Associate Director - HR Business Partner (HRBP) to support our R&D and Corporate Office functions. This role will play a critical part in partnering with business leaders to shape and execute the people strategy, drive organizational change, and support talent development initiatives that align with our overall business objectives. Job Description Key Responsibilities: Strategic HR Partnership: Partner with R&D and corporate leadership to align HR strategies with business objectives. Provide insights and solutions on organizational design, workforce planning, and talent management. Talent Management & Development: Lead talent reviews, succession planning, and leadership development initiatives. Identify skill gaps and collaborate with L&D to implement targeted development programs. Performance Management: Guide the performance management process, ensuring alignment with business goals. Coach managers on feedback, goal setting, and performance improvement. Change Management: Lead HR aspects of organizational change, including restructures, integrations, and process improvements. Act as a change agent to support transformation initiatives. HR Operations & Compliance: Ensure HR policies and practices are compliant with local laws and aligned with company values. Employee Engagement & Culture: Drive employee engagement strategies tailored to R&D and corporate functions. Champion a culture of innovation, collaboration, and continuous improvement. Projects / Initiatives & Strategy: Partner with team in the implementation of the strategic HR Plan, projects and initiatives that add value to both our business and employees. Acts as the performance improvement driver and provokes positive changes in the people management Manages HR Projects cross-functionally. Education & Qualification: - MBA HR with 14+yrs of experience as a HRBP / HR Generalist
Job Description Summary This role requires 1 to 2 years experience. with post-graduation in Chemistry. This job will involve in Analytical support for impurity and nitrosamines synthesis and qualification. Job Description Analytical Method Development, Routine Analytical Support for allotted project Responsible for qualification standards and control for allotted projects To support externals and internal (PD Lab work) queries To support Nitrosamine and impurity qualification. Responsible for daily calibration, document control and compliance . To support the queries for allotted project (API) timely To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab. To ensure cleanness of analytical instruments and working area and update all tag. To analyze RM, in process, Intermediate and API in time. To develop the suitable analytical method and make STP in time. To perform Partial validation, Holding study, DMF queries and physiochemical studies. To support stability sample analysis as per schedule. To ensure completion of documents & data integrity and regulatory environment.
Job Description Summary The Regulatory Affairs Senior Associate is responsible for the preparation, compilation, evaluation and submission of ANDAs & Amendments to USFDA and handling deficiencies with timely submission of responses to agency. Job Description Coordinate with cross functional team/stakeholders (R&D, Quality, manufacturing, SCM, IP, PM) and vendors as required and evaluation of documents in-line with the current regulatory requirements Review of Product Development Report, Executed and Intended Batch Records, Specifications, Analytical Procedures, Method Validation Protocols and Reports & Certificate of Analysis of API / Excipients / In-Process / Finished products/Packaging materials, stability protocols and reports. Review of vendor documents of API, Excipients and Packing materials Review of documents for adequacy (w.r.t content, requirements, legibility, PDF requirements, etc.) Preparation, review and compilation of ANDAs, Amendments and Supplements in eCTD format. Coordinate with Regulatory Operation team member for uploading the submission in e CTD software Review of exported submission shared by Regulatory Operation team for submission . Monitor the FDA website for any updation. Education & Experience :- Master of Pharmacy in Dept. of Pharmaceutics Total experience of 3-5 Years in Regulatory Affairs
Job Description Summary This analyst role is responsible to perform analysis of stability samples, Raw materials, analytical method validation/verification and method transfer studies Job Description To perform Nitrosamine & extractable and leachable analysis of analytical method development / validation / verification and method transfer. Handling of LCMS, ICPMS instruments. Knowledge on nitrosamine method development / validation / verification. Experience: 7 to 9 years with M.Sc./ M. Pharm
The Industrial Relations & Investigation Manager will be responsible for fostering positive labor-management relations, ensuring compliance with labor laws, and leading internal investigations related to employee grievances, misconduct, and policy violations. This role plays a critical part in maintaining a harmonious workplace and mitigating legal risks Job Description Industrial Relations: Develop and implement industrial relations strategies aligned with organizational goals. Manage relationships with trade unions and employee representatives. Lead collective bargaining negotiations and manage labor contracts. Ensure compliance with local, state, and national labor laws. Advise management on labor law implications and best practices. Monitor labor relations trends and recommend proactive measures. Investigations: Conduct thorough and impartial investigations into employee complaints, misconduct, and policy violations. Document findings and recommend appropriate disciplinary actions. Collaborate with legal and compliance teams to ensure investigations meet as per code of conduct . Maintain confidentiality and integrity throughout the investigation process. Master s degree in human resources , Industrial Relations, Law. 12 + years of experience in industrial relations and employee investigations. Strong knowledge of Indian labor laws and employment regulations. Proven experience in conflict resolution, negotiation, and mediation. Excellent communication, analytical, and interpersonal skills.
Job Description Summary Technician required for Compression operation Job Description Safety: 1. To follow and ensure 100% safe operation in manufacturing area. 2. Ensure all the necessary PPEs are available in production facility and were the proper PPEs during manufacturing. 3. Reporting the near miss and ensure their compliances. 4. Follow ISO 14001 & 45001 practices. 5. To follow and maintain 5s in workplace. Quality and Compliance: 1. cGMP Compliance in entire manufacturing area and SOP compliance on all aspects. 2. To ensure zero overdue on trainings. 3. Follow ALCOA++ and ready for any time inspection. 4. Responsible to face regulatory and customer audits. 5. Ensure to follow quality culture in organization. Delivery: 1. To achieve the weekly plan schedule NLT 90%. 2. Responsible to perform the Operation, machine setting, cleaning, in process checks, challenge test and Trouble shooting. 3. To ensure no machine functioning parameters/facility by passed. 4. Proper operation and setting of machines to minimize the spillage and rejection. 5. To maintain the machine, accessories, documents, area, materials, and all other things are in place. Ensure things are in their designed place and vice versa. 6. To maintain machine, area and accessories with minimum breakdown. PMP and spares management. 7. Involved in the dispensing of raw materials. Storage and material movement of dispensed materials. 8. Verification of dispensed materials and in process storage materials against the batch record. 9. Ensure and discuss with supervisor and above if any special precaution (Like staggering during breaks, sensitive product, new product, new PM, new market, offline activity, special/critical product, new manpower, machine issues etc.). 10. Preparation and storage of disinfectant solution and cleaning agents. 11. Issuance and integrity checking of sieves, screen, filter bags, hose pipes, silicon tubes etc... 12. Cleaning and checking of tools before and after completion of batch. 13. Cleaning and storage of Utensils and Production accessories. 14. Indenting, storage, issuance, usage, and destruction of silica gel. 15. Responsible to prevent the cross contamination during manufacturing. 16. Execution of necessary document during cleaning, line clearance and BMR. 17. Performance of in process check and challenge test as per BMR and if any abnormalities observed inform to the superior and QA. 18. Responsible to Monitoring of Environmental condition and reporting maintenance team if any abnormalities noticed. 19. Involved in the Equipment PMP activities along with engineering person. 20. Ensure the calibration of weighing balance & instruments as per the calibration schedule. 21. To give Training to junior level operators and newly joined persons. 22. Identification and initiation of improvement projects in manufacturing. 23. Based on requirements to carry out the activity whenever assigned by management
With HOD and reliever discuss: - Special requirement/ instruction/target, last 2 shift issues, another 3 shifts schedule and additional task if any. Take quick round with the reliever in the entire area: - During round try to touch each and every people and have some specific question may be which are most critical to last 2 shifts issues/area etc. Charge will be taken during round physically area: - Any abnormality observed need to be objected; also, information should go to HOD. Abnormality should be cleared by the doer before leaving the workplace. Come to planning board well advanced (before shift start) and see the schedule status on the board updated and people reporting in the shift on time. Stand at the entry point and ensure: - Everybody reports on time at workplace and charge handover happening at workplace only. Operator handover running machine to the reliever. Proper allocation of part time and full-time employee considering absenteeism if any. Ensure each and every individual should know the shift plan and what to deliver in the shift before going to workplace. It should be predefined, and changes can be only re-communicated. Again, discuss in depth with all concerns (reliever, HOD, department planner, miscellaneous responsible persons) for schedule, investigation and CAPA to incident if any, productivity, quality issues, documents and department works to perform in the shift, this is the understanding for pre and post 3 shifts. Report to the concern workplace: - Instruct offline/ concern people to make arrangement of blend /SFG and any other materials for coming two shift operations. Make responsible offline/concern people to close quality issues, perform quality activity and other miscellaneous activities (like BMR, Training & other arrangements). Batch Manufacturing: - During area round ensure: - People, quality systems, machine, accessories, documents, materials and all other things are in place. Ensure things are in their designed place and vice versa. Interact with Supervisor and understand that they know shift target for output and quality. Ask few casuals that they should know what they are doing and our requirement. Ensure training record of casual if any. Perform critical challenge test and in process checks. Ensure no machine functioning parameters/facility by passed. Talk the same with line people simultaneously. Check the line documents entries (BMR, Logbooks and any formats). Cross verifies with vigilance that correct document, product and manpower used. Ensure and discuss with people that if any special precaution (like staggering during breaks, sensitive product, new product, new market, offline activity, special/critical product, new manpower, machine issues etc. Get pending work from previous shift; get it done from them only. Go through the BMR, blend and machine and ensure correct dose and material used. Evaluate and challenge the working of manpower for correctness and if required retrain them. Ensure no human intervention at any places and correct procedure being followed. Check people should know the batch completion time, SFG quantity, batch yield will give etc. Must be consider for the following: - After completion of round in department report finding to the HOD. No documentation noncompliance and manipulation on dose and process. Keep required manpower on the line. Focus the improvements project like Yield, Quality, Safety, Cost saving and Man hour reduction. All report must be completed like Shift report, DPR etc. Safety, hygiene, discipline and ISO requirements shall be followed in the department. Ensure everybody in shift follow their responsibility. Spend some time for innovation and initiatives in the department. Spend time to train the people. Spend time on other department activities like procurement, change parts, other department issues, meeting and discussion. Ensure people should report and taking permission for each non routine jobs. Spend some time to interact with people. Ensure activities are on- line. Face abnormality and talk to supervisor immediately. Ensure and pass communication in such way that nobody should get of any partial communications; also, it shall not be transferred to other shift people. Ensure special precaution in night shift so that people should not be sleepy. Ensure manpower allocation for each and every activity (like operational lines, wash area, change parts, HK etc.). Be ready to give time to next shift reliever and to take round with him.
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