1756 Gmp Jobs - Page 28

Hi, Greetings from Avani Consulting!! We have job opportunities with API Manufacturing Company for the Sr. Executive/Executive- Electrical position, Mysore Location. Position- Sr. Executive/Executive- Electrical & Instrumentation Work Experience +8 in API / Pharmaceutical / Chemical / FMCG / Continuous Process Industry Location Mysore Qualification- B.E. / B.Tech / Diploma in Electrical Engineering. Knowledge of SAP. Must Have Electrical Supervisor License Job Summary: To lead and manage all electrical maintenance activities and ensure optimal performance, reliability, and safety of electrical systems in an API manufacturing facility. The role also includes efficient management of electrical spares inventory to reduce downtime and support uninterrupted plant operations in compliance with cGMP and safety norms. Key Responsibilities: Electrical System Management - Supervise the operation and maintenance of HT/LT systems, transformers, switchgear, DG sets, UPS, motors, lighting, and earthing systems. - Ensure uninterrupted power supply to production, utility, and HVAC systems. - Implement preventive, predictive, and corrective maintenance strategies. - Analyze root causes of electrical failures and implement long-term solutions. Spare Parts & Inventory Management - Maintain inventory of electrical spares including motors, contactors, cables, breakers, fuses, sensors, etc. - Define minimum/maximum stock levels for critical and non-critical spares. - Coordinate with the procurement team for timely ordering of spares. - Implement inventory control measures through ERP systems like SAP/Oracle. - Carry out periodic physical verification and audits of spare parts inventory. - Monitor consumption trends and optimize stockholding. Project Support & Commissioning - Collaborate with project teams in the electrical design, layout, and commissioning of new installations or equipment upgrades. - Review electrical drawings (SLD, GA, wiring) and ensure implementation as per standards. - Handle site supervision for vendor/contractor activities. Regulatory Compliance & Documentation - Ensure all electrical systems comply with local statutory, safety, and GMP/cGMP requirements. - Maintain and update electrical SOPs, logbooks, PM checklists, and calibration records. - Support audits (internal/external/regulatory) and ensure timely closure of observations related to electrical systems. Team Leadership & Coordination - Lead and manage a team of electricians and technicians across shifts. - Conduct training and skill development for the team on electrical safety, SOPs, and new technologies. - Coordinate with production, QA, EHS, and utility departments for timely maintenance without affecting operations. Key Skills & Competencies: Strong understanding of electrical maintenance in regulated environments (GMP/cGMP). Expertise in operation and maintenance of electrical system up to 66KV Expertise in electrical safety, root cause analysis, energy management, and reliability practices. Hands-on experience with SAP systems for maintenance and inventory control. Strong leadership, team management, and coordination skills. Excellent troubleshooting and analytical abilities If interested, kindly send your updated resume on whatsapp @ 7015954549 with the below details Position Applied for: Executive /Sr Executive Electrical 1. Current CTC: 2. Expected CTC: 3. Notice Period: 4. Current Location: 5. Preferred Mysuru Location: 6. Total Experience: 7. Relevant Years of Experience in E&I: 8. Relevant Years of Experience in Electrical: 9. Have Electrical Supervisor License 10. Years of Experience in (GMP/cGMP) Maintenance 11. Electrical system up 66KV: 12. Years of Experience in API/Pharma/Chemical/FMCG Manufacturing: 13. Current company: 14. Qualification: 15. Experience in SAP: 16. Reason for change: Regards Shweta Gupta

Role & responsibilities Primarily responsible for operation and cleaning of blister machine. Prepare for BMR & BPR of equipment and Batches. Maintain the logs and records of equipment and Batches. Maintain the clean work environment by following the current GMP and SOP. Preferred candidate profile ITI in Mechanical or relevant field.

Role & responsibilities Oversee and manage the entire manufacturing process. Handle Granulation, Compression , Coating and all other production related activities. Active calculation, dispensing of Raw Materials and batch reconciliation at various stages. In process checking at various intermediate stages of Granulation, Compression and Coating. Prepare IQ, OQ, & PQ of the process & utility equipment. Should handle process of validation batches Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Maintain the SOPs, Log books and other documents. BMR / BPR preparation in ERP and review.

Job Summary: Responsible for operation and maintenance of the facilities and utility machineries which includes, Chillers, Heat exchangers, VRF, Makeup air handling units (AHU), House Vac system, Pumps, Vacuum pumps, Wet scrubber, Compressed air systems, Pumps and associated accessories. Ensuring 100% uptime of facility and utility machineries, addressing any mechanical related issues, planning and execution of the planned/unplanned maintenance, maintaining records for all the activities. Providing guidance to the technician on day-to-day activities and should be ready to attend the shift-based operation per business requirements and daily reporting to the technical managers. All time audit readiness Responsibilities: 100% uptime for all the facilities and utility machineries, also responsible for operation of utilities 24x7. Should have good documentation skills. Responsible for operation and adjustment of equipment per facilities requirement. Frequently training and guiding operators and workers on maintenance related activities. Daily tracking and monitoring of equipment performance. Responsible for preparation and updating equipment master list as and when required. Preparation of maintenance calendar for the equipment based on the manufacturer recommendations. Preparation of SOP and Work instructions as per the OEM requirements. Performing planned and unplanned maintenance for the equipment by coordinating with respective users. Maintaining PM, AMC and other maintenance related records for the equipment. Coordination with the external vendors for the OEM dependent activities (AMC). Preparation and maintenance of the critical spares for the machineries as per the OEM recommendations. Verification and maintenance of water generation and storage systems. Quick problem solving and finding root cause for the problems. Reducing MTTR and MTBF for the machineries. Finding root cause and implementing the CAPA for the failures. Ensuring safety, adherence to the procedures and policy. Supporting for the cross functional team. Monitoring technicians performance and providing guidance as and when required. Daily reporting to respective manager. Should have knowledge on GMP. Responsible for Energy conservation, validating and implementing suggestions. Reporting unsafe act and conditions to reduce the incident in the workplace. Kaizen and 5S Skills: Strong knowledge in Operation and maintenance of the utility and facility equipment. Ability to guide the team as and when required. Good communication skills and agile. Should have strong knowledge in electrical machineries like MAU(AHU),Pumps, Chiller ,Cooling tower, vacuum pump, Heat exchangers, VRF, Compressor, plumbing system. Qualification: BE mechanical engineer with 4-6 years of experience in manufacturing /process industries.

Well-versed in HACCP, GMP, and Food and Human Safety. Well-known for the processing activities of Pickles / Spices Industry. Efficient utilization of available resources, machinery and manpower. Progressive supervision & of Different types Pickles.

Job Overview: Overall responsibility for end-to-end project management, including design, budgeting, vendor management, and timely execution at optimal costs. Ensures compliance with GMP, ISO 14001, OHSAS 18001, and other regulatory standards. Leads commissioning, validation, and operational readiness of facilities and equipment. Proactively manages safety, environmental risks, and implements robust SHE practices. Drives continual improvement through risk assessments, CAPA, and comprehensive training for teams and contractors. Reporting Structure: Directly reports to Site Head Positions that report into this role - 6-8 Experience: 15+ years of experience in Manufacturing, GMP, Safety, resolving technical customer queries. Good communication skills Competencies: QMS handling Understanding of changing regulatory requirements Confident to face audits Team Management Quality Investigations Analytical knowledge Collaborating with CFTs SPOC for CDMO projects KEY ROLE & RESPONSIBILITIES: Overall responsible for identification, evaluation & implementation of projects in Time and optimum cost. Designing facilities including buildings, equipment and accessories. Identification of Vendors and Contractors for Projects in various fields. Inspection and testing of equipment and accessories. Inspection of project materials received in the factory. Issue of specifications and drawings for Project items. Approval and rejection of project materials. Project evaluation and review periodically. Preparation of budget and time schedule for all projects. Commissioning of projects. Validation of the facility as per the established procedure. Ensure compliance of legal and other requirements related to ISO14001:2004 and OHSAS 18001:1999. Identification of Risks & Hazards, Environmental aspects & evaluation and review the same. Develop objectives, targets and programmes under EMS & OHSMS. Institute operational controls, monitor the key characteristics, carry out root cause analysis for the Non conformity and take CAPA. Ensure continual improvement in OHS & EMS Management Systems. Identify SHE training needs for awareness and Competence. Ensure SHE requirements wrt contracted services and service providers.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Position: Manager API Production Location: Hyderabad - 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. 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. - - Ensure Preventive Maintenance of Plant Equipment's in time frame. Ensure the training to subordinates. - Extended Facility of reactor Area of Plant-06 production Planning and scheduling (day to day basis)

Overview Location: Chennai, Coimbatore, Bangalore, Hyderabad Experience: 10 to 12 years Skills: CM360 - End to End campaign knowledge and Ad trafficking, Troubleshooting & Reporting, GAM, Team Handling, Stakeholder management This exciting role of an Manager - Ad Operations requires you to creatively manage digital media campaigns for our global brands. Your expertise of ad tech and knowledge of the Digital Market Cycle would make you a great fit for this position. This is a great opportunity to work closely with the Top Global brands and own large and reputed accounts. About us We are an integral part of Annalect Global and Omnicom Group, one of the largest media and advertising agency holding companies in the world. Omnicom’s branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialty communications services. Our agency brands are consistently recognized as being among the world’s creative best. Annalect India plays a key role for our group companies and global agencies by providing stellar products and services in areas of Creative Services, Technology, Marketing Science (data & analytics), Market Research, Business Support Services, Media Services, Consulting & Advisory Services. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together. Responsibilities Managing day-to-day technical relationships with top-tier ad agencies, brands, and media partners Prepping, launching, and maintaining technical aspects of all campaigns Troubleshooting tag-related issues, reporting/delivery discrepancies, and implementation concerns Pulling and reviewing performance data to ensure proper delivery and improve team performance Communicating technical product needs and opportunities to account and product development teams Performing daily QA and integrating quality control into standard operating procedure Continuous process improvements Supervising growth, development, and productivity of ad operations team. Qualifications Any bachelor's degree (Mandatory) 10 to 12 years experience in a technical or ad ops role at an online media company or digital agency Deep knowledge of GMP and related ad serving technologies Comfort and proficiency working with large data sets Positive, professional demeanour and experience working in a client-oriented setting (internal or external) Demonstrated success working in a fast-paced business environment Desire to take on increasing responsibility and grow professionally Proficiency with HTML, SQL, JavaScript, Http Header Analysis, MS Excel and PowerPoint.

Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standard Develop, implement & monitor Quality Management Systems including SOPs, documentation & CAPA systems Handle customer complaints, conduct RCA Required Candidate profile 8–12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge - ISO 9001, GMP & other quality standards

Hiring Quality Engineer with 4–5 yrs exp in manufacturing. Must have knowledge of GMP, ISO 13485, PPAP, MSA, SPC, PFMEA, IQ/OQ/PQ. Strong in supplier quality, change management & validation. Good communication & MS Office skills. Willing to travel!

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

Dear Candidate , we are hiring for QC Jr Executive ,Down stream process executives & Operators. Open Positions-50 Down Stream Process Executives & Operators Required • Qualification: Bsc/Msc/ITI/B Pharmacy Experience in handling the following Equipment 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation,CIP_SIP PRODUCTION-DS M Pharmacy/Diploma/B tech/Any Degree 6 Expertise in documentation QMS/GMP Compliance / Process Awareness Biologics Company's only Preferable. • Experience: 2 to 6 years in Total Downstream CTC :up to 5.0 LPA. IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please reach out Manasa - 9502434725

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725

Who are we At GO DESi, our mission is to make DESi POP ular. We are a packaged food brand making regional DESi products relevant and accessible to customers while ensuring quality and authenticity. Today, the bulk of our products operate in the Impulse category. Our best seller is DESi POPz, we sell more than 90 lakh POPz monthly. Our other categories include DESi Meetha, DESi Mints, and DESi Bytes. We have an integrated backend, i.e., we own the entire supply chain from sourcing to manufacturing. GO DESi aims to be a sustainable brand with the larger purpose of becoming a beacon for non-zero-sum capitalism, where all stakeholders win. Check out more about us. Follow the link below: https://bit.ly/4dWXm7r Brief: We re hiring a hands-on Production Manager - FMCG to lead daily plant operations, ensure timely, quality-driven output, and drive process efficiency. The role demands strong team management, compliance focus, and a results-oriented mindset in a fast-paced manufacturing setup. Job Responsibilities: Plan and execute daily/weekly/monthly production schedules based on sales forecasts. Ensure timely and efficient production to meet quantity and quality targets. Supervise and manage shop floor teams including supervisors and workers. Maintain strict adherence to recipes, process parameters, and standard operating procedures (SOPs). Coordinate with the quality and R&D teams to maintain consistent product quality. Ensure compliance with FSSAI, GMP, and hygiene standards on the shop floor. Monitor raw material and packaging material consumption and stock levels. Coordinate with the procurement team for timely availability of materials. Work with the maintenance team to ensure smooth functioning of machines and utilities. Minimize production losses, wastage, and rework through process optimization. Track and report production metrics like output, efficiency, yield, and downtime. Prepare and maintain all necessary production records and documentation. Train team members on safety, hygiene, and good manufacturing practices. Drive continuous improvement initiatives for productivity and cost efficiency. Ensure workplace discipline, safety compliance, and team motivation Why you should join GO DESi At GO DESi we are growing exponentially and discovering new problems and creative solutions daily. We like to solve problems, take initiative, pitch in when needed, and are always up for trying new things and experimenting. Thats why we seek out colleagues who embody our values. Here, you own your work, right from day one. You can grow enormously if you are a self-learner and embrace challenges.

- Should be aware with GMP. - Should have worked experience of API. - Knowledge of Wet chemistry as well as Instrument like GC,HPLC,IR,UV etc. - Communication should be good. - Knowledge of QMS.

Followings will be the responsibilities of the position holder: 1. Handling shift maintenance activity for Oral dosage manufacturing area. 2. To ensure compliance of GMP/GEP/GDP. 3. To ensure safety compliance as per Abbott Safety Guide lines 4. Work all shifts flexibly when job demands. 5. Diagnose malfunctioning systems, apparatus, and components, using test equipment and hand tools, to locate the cause of a breakdown and correct the problem. 6. Knowledge of PLC, SCADA, Servo Motors & Drives, control valves & switches, VFDs, Relays, and different electronic circuits, motors, star delta starters, relay, Panel & switch gear, Contractor 7. Basic Knowledge of Electrical system. 8. Knowledge of handling equipment s with safety like applying LOTO during maintenance activity. 9. Working in collaboration with the production team to formulate the best cost-effective manufacturing process 10. Supervise electrical works when new installations are undertaken. 11. Learn new skills and attend training programs in other to increase knowledge of trends and best practices in the industry 12. Provide safe working environment for members of staff, and ensure electricity induced accidents and mishaps are prevented t

Followings will be the Core Job Responsibilities of the position holder: 1. Preparation, Issuance, Retrieval & archival of Mastet documents SOP (Forms & Records), Spec & STP (RM, SFG & FG) and other Master documents (List, SMF, VMP, Quality Manual), Master Lists. 2. DARIUS - Software Handling and Compliance 3. Master List SOP, Spec & STPs etc. 4. Issuance of requested Uncontrolled Master documents for closure of CCP/ Exception & requested by cross function department outside the Plant for Reference Purpose. 5. Controlling of General Document Number. 6. To ensure documentation of out of specification, Exception, and Change Control. 7. To ensure the effective implementation of QMS through SolTRAQs application system. 8. To ensure the effective artwork through harmony. 9. Preparation of Maximum Retail Price List. 10. Annual Product Quality Review Preparation of Annual Product Quality Review as per SOP timelines and to identify the improvement areas or recommendations. 11. To perform CAPA effectiveness check activity related to Audit Compliance CAPAs. 12. Preparation for the Training Materials, Coordination with the cross functions for the execution of the trainings as per plan. 13. Updation of the Employee, courses, modules, and other amendments in ISOtrain system. 14. Past due trainings follow up and reconciliation. 15. Maintaining the records of GMP/Technical training and QA department training. 16. To follow all the practices related to Safety and COBC. 17. All miscellaneous activities as assigned by seniors. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. JOB FAMILY: Operations Quality t

To carryout filling and packing activities as per BFR, BPR & SOPs. To follow & maintain current GMP standards in production area/activities. To follow day-to-day production schedule and ensure to complete production activities (filling & packing) as per schedule. To take & follow operating instructions for the shift activities from superior/Manger If any abnormality found in production area / activities, authorized to stop activity immediately & highlight to production Manager. To maintain manufacturing records online & should comply data integrity practices. Indenting, issuance & submission of BFR/BPR. Verification of Raw material & Packing material during receipt. Sample request/submission to QC after filling activity. Transfer finished goods through Finished Goods Transfer Note . Carryout cleaning of filters & storage tanks as per schedule. Ensure & Maintain cleanliness in production area as per SOP. Ensure cleaning of AHU filters as per schedule. To Check and ensure minimum stock of consumables, Log books & status labels. Ensuring preventive maintenance of all equipment as per schedule. Maintain temperature & RH within SOP limits in production area. Co-ordinate with service departments (QA, QC, stores, E & M and SCM) for various production related activities. To follow safety instructions/procedures & ensure use of safety outfit while on works. Responsible to carry out the work of his senior in the absence of senior or authorization from senior. B. Pharmacy or equivalent

Assistant Manager - Quality Job Details | Tata Consumer Products Limited Search by Keyword Search by Location Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Assistant Manager - Quality Tata Consumer Products Limited Assistant Manager - Quality Assurance What are the Key Deliverables in this role? Financial Outcomes Proactively work with Tech-Ops & Planning team to ensure minimization of Material expiry at Plant level. Lunch of the NPD/EPD in their respective cluster with RFT, enabling the zero loss to Business Growth. Effectively Manage the QA budget approved for the Cluster. Customer Service Regular visit of Market and ensure Product Integrity (Product Quality Index & Packaging Quality index) at Consumer Level as per Design Quality. Collaborate with Supply-chain team in addressing the Internal Complaints with high sense of urgency. Collaborate with Procurement/Planning team in resolving the Incoming Materials Challenges with stipulated timeline. Collaborate with TechOps in reviewing the root cause analysis of consumer complaints and Prepare mitigation plan to ensure this does not repeat. Internal Processes Responsible for Implementation of the Corporate SOPs, Process and Practices across the cluster Co-Pack Units Responsible for periodic assessment and Improvement plan of the Co-Pack Operation quality (GMP, RFT, FSSAI/BIS, GLP, Drive the Food Safety Certification for the Co-Packs units Responsible for Managing the Daily Incidents and Deviations in the cluster across Supply-Chain Responsible for Training Program for the respective Cluster team Members (Co-Pack, Tech Ops, Supply-Chai & Sales) Innovation and Learning Responsible to drive the Statistical Process Control (SPC) Program for Continuous Improvements and Risk Assessment of the New Facility in the respective Cluster. Responsible for building the Process Engineering, Automation and digitalization in the respective Clusters. Responsible for New Plant/Line Qualification, Validation and Verification of Existing Product extension. What are the Critical success factors for the Role? B.Tech/M.Sc./M.Tech in Chemical Science/Chemical Engg/Food Process Engg/ Food Tech from a reputed Institute 7+ years of relevant work experience in Liquid Beverage/Food Processing/Flavour/Alcoholic Beverage Industry Technically sound in Water Treatment, Sanitation Program, Homogenization, Heat & Mass Transfer Technology etc Familiar with various Filling Technology (Cold Fill, Hot Fill, Aseptic, Carbonated etc) and Engineering aspects. Well versed with various packaging formats like PET, Cup, Tetra Pack, Glass, Pouch etc and Packing machinery. Rich understating of Calibration, Analytical Chemistry, Microbiology and Packaging Analysis. Good Knowledge in BIS/FSSAI regulations/FSSC/HACCP, ISO22000 and ISO 17025 in document/work Instruction preparation & Implementation. What are the Desirable success factors for the Role? Shall be Sig Sigma Certified, well acquainted with quality improvement tools and Digital Savvy. Knowledge of ISO certification related activities; GLP and GMP guidelines Good verbal and written communications with ability to manage multiple stakeholders (Co-Pack, Tech Ops, Innovation, Sales)

Role & responsibilities Responsibility includes adherence to SOPs/to meet production targets. Maintain GMP & Safety practices. Able to handle and analyse process problems in manufacturing. Sound knowledge of operations of centrifuge/reactors etc. Note: Highest degree must have 1st Class/60 % marks and if 2nd class then 05 years of experience is must

JOB DESCRIPTION Job Title: Analytical ChemistryAnalyst Department : BGRC Job Location: Bangalore About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: The candidate shall be responsible for method development, validation, and stability testing drug substance/drug product. The candidate shall be willing to work in shifts. Hands on experience with complex injectables is an added advantage. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers Shall have experience on Good documentation/laboratory practices such as ALCOA+ Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control) Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards / Chemicals / Reagents / Consumables / Spares etc., required for the projects Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas Experience in developing and validating SEC, CGE methods is an added advantage especially for monoclonal antibodies (mAb) Behavioral Skills Good Interpersonal skills Self-time management Good Team player Polite/Good Communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader (only for Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role Experience 6-8 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, and QC other analytical instruments Good documentation/laboratory practices such as ALCOA+ Particle size determination, Zeta potential and particulate matter analysis techniques is an added advantage Experience in developing and validating SEC, CGE methods for mAbs is an added advantage Able to follow work instructions and perform the tasks under the supervision of the Team leader Preparation and Maintenance of all the documents Good knowledge of MS-office (word, excel, ppt) Education M. Pharm /M. Sc with 3-6 years experience in R&D under GMP environment (QC)

Primary Job Function: Coordinate and oversee the labelling process (Label Change Request LCR) across multiples departments including Labelling Team, Supply Chain, internal and external plants and Local Regulatory Affairs. Ensure compliance with regulatory and quality requirements/standards, manage manufacturing and logistic constraints and implement timely packaging material changes to minimize costs and reduce write-offs. Core Job Responsibilities: Coordinate Labelling Activities for New Product Introduction working in collaboration with Launch Managers to ensure timely product launches Ensure on time execution of Label Change Requests (LCR) by aligning regulatory and quality requirements, technical specifications, and implementation dates. Guarantee that LCR implementation does not adversely affect other affiliates sharing the same products or packaging. Lead effort to swiftly analyze and resolve bottlenecks in the labelling process, facilitating effective communication and collaboration among stakeholders to ensure smooth and efficient operations. Conduct regular performance s reviews with stakeholders to evaluate KPIs, monitor priorities and identify continuous opportunities for continuous improvement in the labeling process. Ensure quality and regulatory compliance of labelling activities and processes in accordance with departmental procedures and applicable Abbott policies. Manage documentation by creating and maintaining Work Instructions and Standard Operating Procedures related to the labelling process. Develop and provide training for Labelling Team personnel and other stakeholders involved in the labelling processes Supervisory/Management Responsibilities: Direct Reports: - Indirect Reports: - Minimum Education: A minimum of bachelor s degree is required, preferably in scientific or business discipline egree or equivalent. Minimum Experience/Training Required: Minimum of 3 years experience in Life Sciences business (Operations, Regulatory, Quality) Proficiency in business systems and tools including Artwork Management System, Enterprise Resources Planning, Project & Portfolio Management solutions. Demonstrated expertise and training in GMP/GxP standards for pharmaceutical products Desired skills/experiences include: Business exposure to international markets Excellent verbal and written communication skills in English including presentation skills. Ability to work effectively within complex organization and collaborate with diverse stakeholders. Strong discipline and stress resilience, with proven experience in managing and delivering multiple tasks on time. High accuracy and attention to detail, with an understanding of the consequences of poor data quality. Strong project management skills, including issue identification, problem analysis and solution development. JOB FAMILY: Engineering LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Role & responsibilities Responsibility includes adherence to SOP's / to meet production targets, maintain GMP & safety practice. Able to handle & analyse process problems in manufacturing. Sound knowledge of operations of centrifuge/reactors etc. Note: Highest degree must have 1st class/60% marks or 5 years of experience if second class.