Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Micro Lead - API Date: May 16, 2025 Location: Ahmednagar - Quality Control Company: Sun Pharmaceutical Industries Ltd Job Description Title: Micro Lead API Location: Ahmednagar Grade: G9B- Sr. Manager 2 JOB RESPONSIBILITIES To plan, review and monitor overall activities in Microbiology and lead the department. Co-ordination with other departments for priorities and provide the timely support/testing to avoid delay due to analysis. Review of all departmental related documents and review results in LIMS system in microbiology section. Ensure all documents are complete in time. To review the lysate sensitivity test, Bacterial endotoxin test of WFI and API products. To check method validation of bacterial endotoxin test and microbial quality of products. To procure, receipt, storage, maintenance, its use and reconciliation of biological indicator, media, reagents standard cultures and bioball etc. To ensure and check calibration and Operation of TOC analyzer Execute breakdown (If any) in consultation with vender. To ensure environmental monitoring activities performed as per schedule and to check the environmental monitoring reports. To review qualification, Calibration of all instruments in microbiology laboratory as per SOP/Schedule. To participate in investigation and to review of deviations/OOS/OOT/OOC/Lab Event / & review of SOPs as per revision date in micro section online in track wise system. To highlight observations, rejection / failure, quality related concern in time and contribute in troubleshooting To ensure and review all logbooks and registers are maintained on line and available at designated place. Preparation and review of GMP documents related to activities. To review and ensure fumigation activity and its verification as per SOP/Guidelines. To prepare / review trends for water and environment monitoring, Summary report of water and environment monitoring. Responsible to follow online good documentation practices for data recording and monitoring. To ensure and review validation of autoclave, Dry heat sterilizer (DHS), Incubators, Laminar Air flow, HVAC. To ensure and review preparation of reagents and volumetric solution and its standardization as per specification / SOP. To ensure and review inventory and stock record of media/reagents/culture/lysate/CSE/LRW. To ensure to follow the GLP as per current practice in the laboratory. To ensure safety and use of personnel protective equipments during day to day activities Responsible for carrying out any other responsibilities assign from time to time orally or in writing by Quality head, however related training imparted to concerns. To support for review and compliance activity in quality function and to support for any time readiness as well as enhancement of system and practices. To Coordinate with corporate functions with respect to microbiology activity. Education : Graduates - Microbiology/ Equivalent ( experience In Micro testing / leading ) Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Engineering Head - API Date: May 22, 2025 Location: Panoli - Engineering Company: Sun Pharmaceutical Industries Ltd Engineering Head – API Grade : DGM / GM Location : Panoli (Vadodara) Job Purpose Lead, plan and directs all aspects of engineering activities within the API plant Organization. Conduct effective reviews of the team and portfolio, provide direction and guidance to the team, and develop team competence with the object of ensuring all engineering projects, initiatives, and processes are in conformance with organization's established policies and goals Duties And Responsibilities Conduct effective reviews of the team and portfolio, provide direction and guidance to the team, and develop team competence Monitor operation and maintenance of Utility and services including water, air ,steam, nitrogen refrigeration , HVAC system in the plant to achieve the desired targets Monitor the maintenance of equipment Modify the equipment as per process requirement / mandates /new projects Monitor the Civil and building management activities Ensure 100% availability of electrical system including DG power and transformers Ensure sterile plant process equipment maintenance Adhere to compliances related to boiler ,factory ,electrical and any other compliance related to Engg Adhere to CGMP compliance for audits participation etc. Ensure plants Energy conservation and cost reductions as per required mandates Ensure adherence to safety compliances are followed in the Engg team Prepare annual budgets ( CAPEX /OPEX) Overall Engineering including Mechanical Maint. of plant, Utility operation, Electrical, Instrumentation, Quality Engineering and execution of capex and Plant modification. Total No. of reactors is 400 with a combined capacity of 1000 KL spread over 14 Production modules. Experience- 20 years. Qualifications Include: Requires a bachelor's degree in engineering preferably Mechanical Knowledge of SAP/ERP systems will be an added advantage. Minimum experience of 20 years with 10 years’ experience in the API industry Having exposure to Energy conservation Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager Corporate Quality Projects Date: May 19, 2025 Location: Ahmednagar - Plant Company: Sun Pharmaceutical Industries Ltd Position: Manager-1 - Corporate Quality Projects Grade: G10 Education: M.Sc / B.Pharma / M.Pharma Job Location: Vadodara Job Profile: LIMS Lead is responsible for To have good experience & exposure of LIMS System implementations (Project developments support, validation, enhancements & implementations) across various site To ensure the dynamics of computerized systems w.r.t regulatory standards (21 CFR part 11, EU Annexure 11, & GAMP 5). To have good experience & exposure of SAP-HANA system, well aware of SAP system functionality. To have very good experience & expertise of Quality Control Systems & process (Functional expertise on sample management & Stability programme) To have very good experience & expertise of Quality Assurance process. To have knowledge of Quality control instruments handlings like HPLC, GC & UV for Sample Managements (Testing), Test Calculations (as per pharmacopeia general chapters & Monographs) & good understanding of Test different-different scenarios (like Dissolution & CU) for fate value check (Pass/fail) To provide guidance/Support sites for all the major regulatory audits by Remotely & Onsite visit Evaluation, assessments of different business requirements received, it’s impact assessments and decision for its consideration for digitization, simplification & automations. To identify the roadblocks and ensure the smooth execution of assigned projects. Responsible to ensure smooth functioning of the team operations and routine activities. Encouraged and developed the subordinates to explore their capabilities and take challenge to grow further. To identify the actionable and accomplish the project milestone. To prepare and review CSAP, qualifications scripts and ensure execution of qualification. To prepare, ensure and support for the preparation of database and design as per compliance requirements and functional needs. To ensure technical training / support for each site, whenever required. To ensure successful handover of projects to Site/Sites & support site SME’s for Stabilization of projects at sites. To conceptualize and frame a consolidated approach for new identified technique. To ensure vendor support for technical discussion on finalize of projects. To perform the activities as per the project plan / assigned scheduler. To execute, support other Quality project initiated for simplification, harmonization and productivity enhancement. To work in collaboration with IT, API, SGO, vendor, Site Quality and different teams for identification of the right solution /tool/Vendor, to resolve the “Specific problem” and have correct solution for the organization. Basic Expectation Candidate should Have a balance of technical knowledge & managerial skills Be able to prioritize & multi -task Be able to work independently with limited supervision Manage stakeholders & get work done Be able to create project plans/Charters which is efficient from a time, cost & effort perspective, while understanding at the long term impact of decisions Analytical & Report Creation Skills - Proficiency in Excel, Word & PowerPoint. Basic understanding of MySQL & Oracle database Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Engineering Head Date: Jun 2, 2025 Location: Panoli - Engineering Company: Sun Pharmaceutical Industries Ltd To maintain facility and equipment. To procure engineering consumables, proprietary spares and to maintain inventory of the same. To perform and to approve Qualification studies for equipment (Plant and Utility) and Facility. To schedule and to execute preventive maintenance program for plant equipment and utility equipment. To review and to participate in process validation program. To maintain and to update drawing like plant layout, equipment layout, P & ID for equipment (Plant and Utility), HVAC system etc. To schedule and to execute Annual Maintenance Program for Utility and material handling equipment. To arrange instruments for plant equipment and accessories. To review, authorize and to comply all Quality documents. To ensure statutory compliance of boiler/electrical inspector & standard weights. To execute modifications in plant as per approved capex and requirement by plant. To ensure cGMP & EHS compliance. To arrange the training of department employees for SOP, new system, Qualification etc. To review maintenance report and energy consumption to ensure corrective action for control of same. To review annual engineering budget. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Sr. Manager - Micro Lead Date: Jun 3, 2025 Location: Ahmednagar - Quality Control Company: Sun Pharmaceutical Industries Ltd Job Title: Manager / Sr.Manager – Micro Lead Job Grade: G10 / G9B Function: Global API Business Sub-function: Manager’s Job Title: Skip Level Manager’s Title: Function Head Title: Location: Ahmednagar No. of Direct Reports (if any) Areas of Responsibility To plan, review and monitor overall activities in Microbiology and lead the department. Co-ordination with other departments for priorities and provide the timely support/testing to avoid delay due to analysis. Review of all departmental related documents and review results in LIMS system in microbiology section. Ensure all documents are complete in time. To review the lysate sensitivity test, Bacterial endotoxin test of WFI and API products. To check method validation of bacterial endotoxin test and microbial quality of products. To procure, receipt, storage, maintenance, its use and reconciliation of biological indicator, media, reagents standard cultures and bioball etc. To ensure and check calibration and Operation of TOC analyzer Execute breakdown (If any) in consultation with vender. To ensure environmental monitoring activities performed as per schedule and to check the environmental monitoring reports. To review qualification, Calibration of all instruments in microbiology laboratory as per SOP/Schedule. To participate in investigation and to review of deviations/OOS/OOT/OOC/Lab Event / & review of SOPs as per revision date in micro section online in track wise system. To highlight observations, rejection / failure, quality related concern in time and contribute in troubleshooting To ensure and review all logbooks and registers are maintained on line and available at designated place. Preparation and review of GMP documents related to activities. To review and ensure fumigation activity and its verification as per SOP/Guidelines. To prepare / review trends for water and environment monitoring, Summary report of water and environment monitoring. Responsible to follow online good documentation practices for data recording and monitoring. To ensure and review validation of autoclave, Dry heat sterilizer (DHS), Incubators, Laminar Air flow, HVAC. To ensure and review preparation of reagents and volumetric solution and its standardization as per specification / SOP. To ensure and review inventory and stock record of media/reagents/culture/lysate/CSE/LRW. To ensure to follow the GLP as per current practice in the laboratory. To ensure safety and use of personnel protective equipment’s during day to day activities Responsible for carrying out any other responsibilities assign from time to time orally or in writing by Quality head, however related training imparted to concerns. To support for review and compliance activity in quality function and to support for any time readiness as well as enhancement of system and practices. To Coordinate with corporate functions with respect to microbiology activity. Travel Estimate Job Requirements Educational Qualification M.Sc (Microbiology) Specific Certification Skills Experience 15 to 18 Yrs Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Manager - Production Date: May 19, 2025 Location: Panoli - Prodcution Block 6 Company: Sun Pharmaceutical Industries Ltd Job Description Position: Sr. Manager - Production Job Title: Job Grade: G9A Function: Global API Business Sub-function: Manager’s Job Title: Skip Level Manager’s Title: Function Head Title: Location: Panoli No. of Direct Reports (if any) Areas of Responsibility Production planning and scheduling (day to day basis.) Ensuring resources available (BMR, Raw Material Manpower etc.) Maintain GMP norms and trained the subordinates accordingly. Review the BMR, incident and change control etc. and accordingly co-ordinate with R&D. Co-ordination with Engg. Dept. for preventive maintenance and calibration Ensure to maintain the online documentation and accordingly train the subordinate. Close co-ordination with service dept. like QA, QC, Store, Egg, Safety etc. for Routing work of plant. Ensure create and confirm the process order and ensure to complete the daily entry in SAP HANA. Liaison with QC/QA/Store/Engg. Dept. for solving of trouble shooting problem. Constantly monitoring and improvement of product process, efficiency, services etc. Reporting to higher authority. Ensure Training to subordinate. Ensure Documentation work, monthly reports, data preparation, root cause analysis, incident and change control etc. (process trend analysis). Ensure Preparation/ Revision of BMR & related accessories and SOP. Procurement of consumable items. Actively involves the Process and cleaning validation. (where applicable) Ensuring the Maintaining of documents related to Process/ Cleaning/ HouseKeeping. Control on fresh as well as recovered solvents/ spent solvents Responsible for administrative work related to plant Co-ordination with other department for solid waste, process waste and spent solvent transfer to respective area and record maintaining. To maintain discipline as per company's rules and regulation. Other Activities entrusted from time to time Preparation, review and revision of SOP. Working as a Department Training coordinator in LMS Operation of electronic system like SAP HANA, Leave Portal etc. Travel Estimate Job Scope Internal Interactions (within the organization) External Interactions (outside the organization) Geographical Scope Financial Accountability (cost/revenue with exclusive authority) Job Requirements Educational Qualification MSC / BE/ B.Tech – Chemical Specific Certification Skills API Production Experience 17 to 19 years of work experience. Handle team size of 150 to 200. Handle Production capacity of minimum 50 Cr. In Current role, he should be heading block. Apart from this experience of handling QMS, Capacity Enhancement, Solvent recovery. API regulatory plant experience. 2 | P a g e Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Manager - Production (API) Date: May 24, 2025 Location: Panoli - Prodcution Block 6 Company: Sun Pharmaceutical Industries Ltd Role : Sr.Manager Production (API) Role: Sr. Manager - API Production Location: Panoli (Baroda) Grade: Sr. Manager Educational Qualification B.Pharma/M.Pharma Work Experience 17 to 19 years of work experience. Handle team size of 150 to 200. Handle Production capacity of minmum 50 Cr. In Current role, he should be heading block. Apart from this experience of handling QMS, Capacity Enhancement, Solvent recovery. API regulatory plant experience. Roles & Responsibilities : Production Planning and scheduling (day to day basis) Ensuring resources available (BMR, Raw Material Manpower etc.) Liaison with QC/QA/STORE/Eng. Dept. for solving of trouble shooting problem. Implementation and monitoring of GMP Standard. Introduction and scale up of technology transfer. (New Prod 1ct) Constantly monitoring and improvement of product process, efficiency, services etc. Documentation work, Monthly Report, data preparation (Process trend analysis) and root cause analysis. Ensure the availability of consumable items & Planning of RM require as per campaign basis. Ensure the documents related to process I cleaning / House Keeping. Control on fresh as well as recovered solvents/ spent solvent. Ensure the solid and process waste transfer to respective area and record maintaining. Other activities entrusted from time to time. Review the prepared/ Revision of BMR and SOP. Operation of electronic system i.e.ONE HR portal, Metis Track wise, Minitab, Out Look etc. Ensure Preventive Maintenance of Plant Equipment's in time frame. Ensure the training to subordinates. Extended Facility of reactor Area of production Planning and scheduling (day to day basis) Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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Title: QA Head API Date: May 15, 2025 Location: Panoli - Quality Assurance Company: Sun Pharmaceutical Industries Ltd JOB DESCRIPTION Position : QA Head Effective Date: Reports to : Quality Head Job Code: Department: Quality Grade: Functional Area: QA Location: Panoli POSITION SUMMARY Manage overall quality assurance oversight and site activities wrt to quality systems: documentation review and SOP update, in-process quality assurance, sampling and batch release, preventive maintenance/calibration/qualification/validation, internal audit, compliance, quality oversight of electronic systems, budget, and continuous improvement of quality systems, RA support, monitoring of pest control, retention sample management as per Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures. Key Responsibilities: Responsible for defining operational strategy and road map for quality assurance management at site. Define site quality assurance goals and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Effectively manage the site Quality Assurance activities and resources necessary to smoothly run the QA operation at site. Provide strong leadership and expertise to ensure achievement of all Quality Assurance accountabilities at site. Identify and implement solution for improving existing site quality assurance systems and processes. Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Ensure that performance issues are managed in a consistent and timely manner. Develop site quality assurance revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year. Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements. Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams. Responsible for executing Quality Management Reviews at site, monitor individual Performance and set improvement areas. Responsible for ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timeline. Responsible for ensuring compliance to regulatory requirements on product, process and release procedures. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment. Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies. Review & tracking of quality assurance metrics e.g. deviation, change control, OOS/OOT, CAPA effectiveness, market complaints with site manufacturing / QC Management and driving them down. Ensure processes for supply chain management / Global Material Sourcing for vendor selection is followed for vendor selection, qualification and monitor vendor quality performance Provide inputs to manufacturing, R&D and PDL work processes to ensure Quality by Design. Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QA systems at the site. Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner. Monitor industry trends/issues faced internally and identify scope for improving Site quality assurance management and processes. Responsible for fulfilling all training requirements of quality assurance employees. Ensure the quality policies, standards and procedures for computerized systems are implemented and adhered at site. Ensure all GxP computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle with adequate security and controls to ensure data security. Review and approve the documents as per quality procedures. Work in partnership with the site cross functions and corporate functions for implementation of new initiatives. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS Science or Pharmacy Graduate Equivalent 15 years REQUIRED SUCCESS ATTRIBUTE Knowledge of GxP’s, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving Roles WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Additional responsibilities can be assigned as required. Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. DELEGATION OF RESPONSIBILITY In the absence of job holder, delegation of responsibility will be as follows: Upward Delegation – Strategic site responsibilities to higher level Downward Delegation – Operational responsibilities to direct reports or similar job role ___________________ __________ Department Head Date ____________________ __________ Human Resources Date This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Manager - Engineering Date: May 17, 2025 Location: Ahmednagar - Plant Company: Sun Pharmaceutical Industries Ltd Responsible for Design and establish the system for maintaining all documents and records of Mechanical as per regulatory requirement. Responsible for Engineering and Project coordinate with site Engineering and Project team to synchronized with site Quality, Production, Health and Safety Dept. To guide and train the department personnel by identifying the training needs. Preparation of annual Engineering Budget (Opex & Capex) to meet the Business Plan. Monitor a list of project activities and key milestones (on the critical path) in line with the project plan. Maximize the resource utilization and flexibility while minimizing the energy, water and utility costs to achieve the target. Responsible to design and establish the systems for maintaining all documents and records of mechanical / electrical maintenance as per regulatory requirements. Responsible to coordinate with vendor and site contractor and sync with site quality, production, Health & Safety department. Propose annually a list of activities and project key milestones (on the critical path) in line with the project plan and consolidates annual objectives. Monitoring the regulatory compliances, Audits and Compliances. To develop system and processes to monitor and optimize engineering resource utilization. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Manager - Engineering Date: May 24, 2025 Location: Ahmednagar - Engineering Block 1 (1,2,2E,3,Pilot,8 Company: Sun Pharmaceutical Industries Ltd Job Title : Sr. Manager - API Mechanical Maintenance Management Location : Ahmed Nagar Job Summary : We are looking for an experienced Sr. Manager to lead our API Mechanical Maintenance Management team. The successful candidate will be responsible for developing and implementing mechanical maintenance strategies to ensure optimal performance, reliability, and compliance of API manufacturing equipment and facilities Key Responsibilities: Develop and implement comprehensive mechanical maintenance management plans for API manufacturing equipment like Reactors, Centrifuges, ANFDs, and all types of Drying systems, Vacuum systems , and including clean room facilities. Lead and manage a team of mechanical maintenance personnel, providing guidance and training on API-specific maintenance practices. Collaborate with cross-functional teams (Production, Quality, and Engineering) to identify and prioritize maintenance activities. Develop and manage maintenance budgets, ensuring cost-effective maintenance practices for API manufacturing equipment. Ensure compliance with regulatory requirements (cGMP, FDA, etc.) and internal quality standards for mechanical maintenance. Implement and manage preventive maintenance programs for API equipment, including scheduling, execution, and documentation. Conduct regular maintenance audits and risk assessments to identify areas for improvement. Develop and implement corrective actions to address mechanical maintenance-related issues. Collaborate with external vendors and contractors to ensure effective mechanical maintenance support. Develop and maintain maintenance-related documentation, including SOPs, procedures, and records. Requirements: Bachelor's degree in Mechanical, Chemical Engineering. Minimum 8-15 years of experience in maintenance management, in a API manufacturing environment. Proven experience in leading and managing maintenance teams, with a focus on mechanical maintenance. Strong knowledge of cGMP, FDA regulations, and industry best practices for API manufacturing. Excellent communication, leadership, and Maintenance & project management skills. Ability to work in a fast-paced environment and prioritize multiple tasks. Desirable: Master's degree in Mechanical, Chemical Engineering, Certification in maintenance management or a related field. Experience with computerized maintenance management systems (CMMS). Familiarity with lean manufacturing principles and Six Sigma methodologies. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Sr. Manager - Engineering & Projects (API) Date: Jun 4, 2025 Location: Ahmednagar - Projects Company: Sun Pharmaceutical Industries Ltd Qualification: B.E. / B.Tech. (Mechanical) Experience: 10 to 15 yrs experience in API manufacturing plant in Engg. & Project dept Job Profile Quality:. Engineering Quality System, Faced Regulatory Facility Audits Budget : Preparation of annual Engineering Capex & Plant Modification costing to meet the site business Plan. Strategic plan: Responsible to prepare SOPs and to suggest for corrective actions related to project management Responsible to prepare Qualification Protocol ( DQ, IQ, OQ & PQ). Responsible to train the department personnel by identifying the training needs. Responsible to participate in Self inspections. To ensure for the availability of critical spares/ consumables during the commissioning of New equipment’s. To ensure that Good Engineering Practices are implemented. To conduct vendor inspections as and when required. Responsible for imparting training to the personnel in Engineering Dept. SOPs related to their job roles. Propose annually a list of activities and Project Key Milestones (on the critical path) in line with the project plan. Strong project management skills. Must have basic knowledge of Electrical & Instrumentation. Must have Exposure to: USFDA, EMEA, UK MHRA, ANVISA and other regulatory compliances, Monitoring, Operational Excellence, Audits and Compliance. Continuous Improvement process: Maximize the resource utilization and flexibility while minimizing the energy, water & utility costs. Basic knowledge on Lean manufacturing System (Kaizen) Performance plan and Follow-up: Develop Systems and processes to monitor and optimize engineering resource utilization Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager, Microbiology Date: May 9, 2025 Location: Dadra - Quality Control Company: Sun Pharmaceutical Industries Ltd Manager, Microbiology Location: Dadra Designation: Manager 2 Education: BSc / MSc in Microbiology Experience: 10+ Years Maintain the microbiology laboratory as per regulatory requirements. Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples. Handling of microbiology related OOS/OOT, Deviation, Lab event. Prepare the response and closure of audit observations. Change control management for revision of SOP’s, Validation protocol. Ensure the availability of resources of microbiology laboratory. Ensure the microbiologist certification program of all microbiologist. Implementation of new projects for cost saving, compliance enhancement , work simplification. Having technical knowledge of following major test MLT of OSD products and MLT validation. Disinfectant efficacy test ( Disinfectant Validation) Maintenance of microbial cultures Maintenance of Microbiological media, Growth promotion test. Autoclave validation LAF, Biosafety cabinet, Incubators, pass box validation. Objectionability assessment of identified inhouse isolates. ALCOA++ Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211 Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment. Purified water system validation. Chemical and microbial analysis of water. Audit experience for FDA, MHRA. ANVISA, TGA etc. Handling of software following but not limited: SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software Hands on experience of major instruments like: Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Executive Date: May 16, 2025 Location: Gurgaon - Office Company: Sun Pharmaceutical Industries Ltd Job Title : Accounts Payable Reviewer/automation Job Summary : The accounts payable reviewer is responsible for overseeing the accounts payable process to ensure accuracy, compliance and efficiency in this payment cycle . This ideal candidate will have a strong understanding of accounting practices, a keen eye for details and the ability to identify and resolve discrepancies before payment processing . Have a good understanding of accounting, TDS and GST. Experience : Using accounting software e.g sap and MS office . Knowledge of automation tools and technologies. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Date: Jun 4, 2025 Location: Gurgaon - R&D Company: Sun Pharmaceutical Industries Ltd List Of Responsibilities / Job Functions: The job exists to provide quality, efficient and timely analytical support to product development team during method development and process optimization studies by analyzing samples of excipients, active drug substances and drug formulation, for chromatographic purity, assay, dissolution and related substances tests by GC and wet chemical techniques. Further is to execute all analytical work keeping in view the compliance, documentation integrity and performance execution. Execution of experiments during method development, method evaluation and analysis for optimization samples of drug products and out sourced API’s. Calculation of data and preparation of results of analysis Handling troubleshooting Managing delivery within stipulated timelines Online observation of any failure of system and procedure and highlight the same to Lab supervisor Review of literature for effective use of knowledge during method development Interaction with “Product development and Research” and Support functions Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Deputy General Manager Date: Jun 4, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Title: Group Leader US & OAM Job Grade: G8 Department: Regulatory & Business Continuity Business Unit/ Division R&D Baroda Manager’s Job Title: Group Leader Regulatory & Business continuity for US/OAM Span of control Direct: Total: 6 Reporting structure Direct to Head Job Description Version and date 1.0 / 10-Oct-24 Area Of Responsibility Actively involved in development, filing related activities for products assigned to team members. Pre-filing activities: Guidance/review of various correspondences with the agency like controlled correspondences, Pre ANDA, NDA meetings, HF, FOI requests, etc. Pre PIF-evaluation for US products. Regulatory operations: Shared goals, R&D Metrics, Approval calendar, QRM, Budget, Approval benchmarking, Portfolio management Cross functional team support to Baroda/Gurgaon/Princeton - Technical/guidance/providing information Work planning for Baroda team Ensuring team productivity and optimal utilization of resource Allocation of RA scientist to all DF products Recruitment, retention and development of talent Ensure timely and quality filing to ensure timely approval Managing changing requirements/expectations from the Agencies New process establishment for smooth functioning of department Creation and maintenance of various data base for ease of referencing, trend data analysis for management review Technical communication for dossier filing Resolution/trouble shooting/de bottlenecking wherever required during Pre-filing, filing and post filing. Geographic Scope/ Market US, EU, Japan, Australia, Canada Work Conditions: Full time Physical Requirements: Presence at work Travel Estimate Infrequent Education and Job Qualification M. Pharm Having knowledge and good understanding of the filing requirements for ANDA/NDA/INDs, Query responses, Pre-filing development related activities, Pre PIF-evaluation for US. In-depth knowledge of filing requirements for ANDA/NDA/INDs, Pre-filing development related activities good understanding and interpretation of USFDA guidance’s which helps to define correct strategy. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Date: May 10, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Primary Responsibilities: Analytical Method development for API/NCE sample. Analysis of raw material, Intermediate, API/NCE samples on gas chromatography, liquid chromatography and chemical analysis. Method validation for API/NCE purity, impurity, excipients methods. Trouble shooting of various analytical issues for various products. Maintenance, calibration & trouble shooting of HPLC and GC. Preparation of SOP for related to instrument and system. Method transfer and method demonstration at other location as and when required. Documentation like ATP, Development report, Validation protocol, Validation report, STP preparation. To work as per cGMP/OECD GLP and to ensure its compliance. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Biotechnology Date: May 28, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd The candidate is expected to develop Surface Plasmon Resonance (SPR) based methods to measure the kinetic and equilibrium binding constants for protein and peptide products. Responsible for analytical method qualification for all pipeline products. Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. Analytical similarity assessment of in-house products. Preparation of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. The candidate is responsible for the operation and maintenance of the SPR instruments To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues. Educational Qualification: M.SC./ in Biochemistry / Life Sciences / Biotechnology. Technical/functional Skills: Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins. Experience of biosimilarity assessment of biologics for regulated market is desirable. Experience of analytical development for monoclonal antibodies and peptide is highly desirable. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Date: May 21, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Designing, executing and interpreting bioassays/pharmacological studies. Knowledge of GLP/GMP. Leading and managing in-vitro/in-vivo projects, ensuring timely completion Mentoring junior scientists, building and leading cross functional teams Analyzing data, preparing reports and presenting to stakeholders Collaborating with other departments, to advance progress of projects Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Date: May 29, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd GLP Bioanalytical To Access Study Plan and Standard Operating Procedures and to comply with instructions given in Study Plan and Standard Operating Procedures. To record raw data promptly and accurately and in compliance with the Principles of Good Laboratory Practice, review of raw data and are responsible for the quality of their data. Operation Maintenance and Calibration of Liquid Chromatography and Tandem Mass Spectrometer (LC/MS/MS). To perform the method Development, method validation and study sample analysis (non-clinical) for GLP Studies. Preparation of ATP (Method SOP), SOPs, Template for GLP Studies. Sample preparation for MD, MV and study analysis as per GLP guidelines. Pipette Maintenance and calibration assigned to the group. Other Job Responsibilities Assigned By Reporting Authority. Preparation of method validation/partial method validation reports and bioanalytical study reports for GLP studies in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP. Documentation of any type of Deviation in GLP study report & communicated directly to the Study Director and/or if appropriate, the Principal Investigator. Responding to QA observations for bioanalytical reports in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Date: May 27, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Description Experience in Formulation R&D product development with experience in injectable product development in Novel drug delivery systems/Lyophilized product/Solution product. To do literature search relevant to projects requirement and understanding of Regulatory guidance. To procure raw materials (API/excipients), packaging materials and Reference product in consultation with packaging/purchase department. To prepare request application for Testing/analysis license for new product/Reference product. To design, conduct pre-formulation and formulation developmental experiments with QbD approach and to enter the details about drug product manufacturing experiments in Lab Notebook. To prepare TR/IOM for the respective API/Excipients/product sample analysis. To prepare product development/stability study protocols and reports, prepare SOPs for related laboratory equipment/instrument and maintain critical data records for regulatory audits. To prepare document for Technology Transfer like sheet II, Master Formula, Risk assessment based upon CPP & CQA, FMEA and SDS. Group work for lab management, handling instrument, common group activities and co-ordination with cross functional teams for handling projects issue. To support cross functional activities at plant for Scale- up/ Exhibit batches/commercial batches and new assignments. Preparation of Product development report (PDR), Risk assessment reports and do compilation of project issues. To comply with the internal quality system while performing any activity. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less