1756 Gmp Jobs - Page 23

We are looking for an experienced candidate 8 to 15 Years to lead our Toolroom team. If selected, the candidate will be in charge of leading all team members Sr. Tool Maker, Designer, Programmer & Operators. The leader must ensure all toolroom projects are completed on time as per customer requirements. The person will be accountable for the Profitability of the toolroom vertical. Responsibilities Complete feasibility analysis & costing for all RFQs Work with Sales & Marketing to convert RFQs into POs Review of all mould design using Solidworks Complete development of New Moulds on time, within budget, and handed over to production with all relevant documentation Ensure all Toolroom team members are performing as per expectations Responsible for training & retaining of toolroom team IATF 16949 Documentation to be prepared and maintained Daily, weekly & monthly plans to be prepared for preventive/ breakdown maintenance of moulds Must coordinate with other toolroom vendors Must regularly & Independently review machining hour calculation & utilization Must be able to identify problems, give solutions to prevent delays in deliverables Must be able to work without supervision & capable of reporting to management Candidate Profile DPMT Diploma in Plastic Mould Technology with PD PMD from CIPET/NTTF /GTTC Min. 8 years of experience in design and manufacture of plastic injection/ thermoset moulds Must have experience managing projects involving manufacturing IM moulds & mould finishing including activities such as laser etching, chemical etching etc Fluent in MS OFFICE (Primarily MS Excel) Good Communication Skill (English 3/5 || Tamil 4/5) Must be within 40 mins by bike ride to the factory or willing to relocate Benefits Company will provide ESI & PF benefits Company will provide daily lunch at subsidized rates CTC of Rs 12 Lakhs/ year for candidates with Min. 20 years relevant work experience Interested Candidates can call me at Thanks and Regards L Sainath Jayaram SAI HR CONSULTANTS FOUNDER & CEO 8015088704 / 8754456288 sainathjayaram95@gmail.com

5 years of experience in plant operations, administration, or security coordination in a manufacturing Emergency handling, shift supervision. -Experience as Night Managers - Ability to handle emergency situations - Preferably retired forces personnel Required Candidate profile Graduate in any discipline (preferably Science/Engineering/Pharmacy). Proficient in both English and local language. Must reside near the plant Must have two-wheeler/four-wheeler Night Shift

As the leading international supplier of active pharmaceutical ingredients (APIs), we at TAPI take pride in our extensive portfolio of over 350 API products and our reputation as a trusted partner for 80% of the top 50 global pharmaceutical companies. With a history dating back over 80 years, we have established ourselves as industry leaders through our experience, expertise, technologies, and exceptional customer service. Our success is driven by our dedicated team of over 4,000 professionals spread across 14 sites worldwide, with state-of-the-art production facilities in multiple countries. We are committed to continuous innovation and investment in research and development to ensure a steady flow of high-quality APIs and the timely introduction of new products to the market. In this role, you will be responsible for various aspects of product transfer, scale-up, proposals, Capex evaluations, and process engineering calculations. Your key tasks will include improving the yield, efficiency, and cost effectiveness of developed APIs by introducing new technologies, troubleshooting plant-related problems, and contributing novel ideas during technical discussions. Additionally, you will be involved in cycle time reduction, capacity enhancement, and coaching and developing a team of engineers to drive performance and engagement. The ideal candidate will have a solid background in API manufacturing, with a deep understanding of scale-up processes and experience in handling CDMO products. You should possess expertise in chemical process unit operations, Quality by Design, process safety, technology transfer, and commercial production. Strong communication, project management, and supervisory skills are essential for collaborating effectively with internal teams and external stakeholders. To qualify for this role, you should hold a B.Tech/M.Tech in Chemical Engineering from a reputable institute and have 14-16 years of experience in the field, including at least 5 years in people management. Your ability to handle multiple projects simultaneously, troubleshoot issues, and use process modelling tools will be critical for success in this position. If you are a proactive, detail-oriented professional with a can-do attitude and a passion for driving excellence in API manufacturing, we invite you to join our team at TAPI and play a key role in our mission to deliver high-quality pharmaceutical ingredients to the global market. This position reports to the Associate Director, MS&T.,

We are currently seeking a Qualified Person (QP) to join a prominent pharmaceutical company situated in the Hertfordshire region. As the Qualified Person, you will play a crucial role in the organization by performing various responsibilities. Your primary duties will include conducting QP batch release activities, supporting the day-to-day functioning of the Quality Management System, and ensuring compliance with the QP Code of Practice and Eudralex Volume 4 GMP guidelines for QPs (Annex 16). Additionally, you will be responsible for undertaking routine product certification as a Qualified Person in alignment with relevant regulations and standards. Moreover, as a Qualified Person, you will contribute to the maintenance of GMP & GDP standards across all site operations. To excel in this role, you should possess a relevant degree in a scientific discipline, demonstrate proven industry experience in pharmaceutical quality assurance, and exhibit a solid understanding of GMP and GDP standards. Your expertise in these areas will be crucial in ensuring regulatory compliance and upholding quality standards within the organization. In conclusion, this position offers an exciting opportunity for a Qualified Person to make a significant impact within a leading pharmaceutical company. If you meet the specified requirements and are keen to advance your career in the STEM sectors, we encourage you to apply for this role at the earliest opportunity.,

Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us are driven to help improve patients lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title - Senior Engineer, Sterility Assurance Location - Whitefield, Bangalore With minimal guidance, schedules and leads through the planning and execution of a smaller project or defined piece of a larger project for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs and Solutions. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups. The candidate should have a strong background of sterilization validation and should have a strong understanding of the scientific aspects related to sterilization and Sterility Assurance. The incumbent will be required to have the knowledge & will be required to provide support in following. Devices new approaches to complex problems through adaptations and modifications of standard technical principles, ability to prioritize multiple tasks. Supervises/coordinates an engineer and/or technicians on assigned work. Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices/ disposables. Planning, execution, and documentation of sterilization cycle development for Ethylene Oxide sterilization, Radiation sterilization/ Moist heat sterilization. Good understanding of Life Cycle of sterilization development, Assessment of result & to verify if anything goes wrong in the process. Strong Leadership skills, team orientation and understanding of organizational cultural attributes. Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)- Quality Assurance, Validation. Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable. Essential Duties and Responsibilities Demonstrated competency in one or more sterilization technologies including moist heat, radiation or ethylene oxide and aseptic processing. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Effectively operate in and may facilitate cross-functional teams with guidance. Must be able to provide solutions that reflect understanding business objectives and cost implications. Contribute to technical feasibility analysis of complex research and design concepts for the sterility assurance and related controls for the products. Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle-time. Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical device, Solutions & pharmaceutical projects. Perform standard sterilization engineering assignments for application, validity, and conformance to specifications. Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives. Study and recommend techniques to improve existing products/processes and process controls. Provide sterilization support for R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP). Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction. Demonstrate working knowledge of basic technical theories and principles within the area of expertise for routine tasks. Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles. Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. Develop reports and presentations on technical plans and results. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Knowledge around microbiological aspects of Biological indicators, Adventitious Agents and related microbiological concepts. Qualifications Master s degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 8 years or BS with minimum 10 years experience in sterilization validation or equivalent. Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods (e.g., "six sigma") Display a solid technical understanding of Sterilization Engineering principles and qualification practices & application of these principles on individual/small projects. The position requires technical skills for device sterilization using Gas (EO/VHP) / Radiation, assessing critical changes & impact assessments, writing study rationale documents. Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies. Skills Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones. Proficient with Sterilization validation principles and related testing for Biological indicators etc. Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators. Highly adept at grasping and solving complex problems using root-cause analysis techniques. Ability to objectively identify technical solutions and make sound decisions Project management experience for Quality & value improvement projects Self-driven, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Strong acquaintance with technology, QMS tools and collaboration tools over the web: e.g. Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc.

Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us are driven to help improve patients lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title - Principal Engineer, Sterility Assurance Location - Whitefield, Bangalore With minimal guidance, schedules and leads through the planning and execution of a smaller project or defined piece of a larger project for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs, and Solutions. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups. The candidate should have a strong background of sterilization validation and should have a strong understanding of the scientific aspects related to sterilization and Sterility Assurance. The incumbent will be required to have the knowledge & will be required to provide support in following. Devises new approaches to complex problems through adaptations and modifications of standard technical principles, ability to prioritize multiple tasks. Supervises/coordinates an engineer and/or technicians on assigned work. Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & topics related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices/ Solutions. Planning, execution, and documentation of sterilization cycle development for Moist heat sterilization. Ethylene Oxide sterilization, Radiation sterilization Good understanding of Life Cycle of sterilization development, Assessment of result & to verify if anything goes wrong in the process. Strong Leadership skills, team orientation and understanding of organizational cultural attributes. Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)- Quality Assurance, Validation. Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable. Essential Duties and Responsibilities Demonstrated competency in one or more sterilization technologies including moist heat, radiation or ethylene oxide and aseptic processing. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Effectively operate in and may facilitate cross-functional teams with guidance. Must be able to provide solutions that reflect understanding business objectives and cost implications. Contribute to technical feasibility analysis of complex research and design concepts for the sterility assurance and related controls for the products. Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle-time. Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical device, Solutions & pharmaceutical projects. Perform standard sterilization engineering assignments for application, validity, and conformance to specifications. Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives. Study and recommend techniques to improve existing products/processes and process controls. Provide sterilization support for R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP). Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction. Demonstrate working knowledge of basic technical theories and principles within the area of expertise for routine tasks. Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles. Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities. Develop reports and presentations on technical plans and results. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Knowledge around microbiological aspects of Biological indicators, Adventitious Agents, and related microbiological concepts. Qualifications Master s degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 12 years or BS with minimum 14 years experience in sterilization validation or equivalent. Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods (e.g., "six sigma") Display a solid technical understanding of Sterilization Engineering principles and qualification practices & application of these principles on individual/small projects. The position requires technical skills for device sterilization using Gas (EO/VHP) / Radiation, assessing critical changes & impact assessments, writing study rationale documents. Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies. Skills Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones. Proficient with Sterilization validation principles and related testing for Biological indicators etc. Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators. Highly adept at grasping and solving complex problems using root-cause analysis techniques. Ability to objectively identify technical solutions and make sound decisions Project management experience for Quality & value improvement projects Self-driven, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Strong acquaintance with technology, QMS tools and collaboration tools over the web: e.g. Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc.

Job Title: Site Quality Head - API Business Unit: Global Quality And Compliance Job Grade G6 - Senior General Manager Location : Ahmednagar Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Position Summary - Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Provide leadership and direction to ensure achievement of all site accountabilities for QA, QC and Stability at site. Proactively assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at the site and track quality assurance/control metrics with site manufacturing and drive them down. Assure all time readiness of site for regulatory agency inspections\internal audits at any given point 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 Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down. 2. Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and Quality systems at the site 3. Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies and cost effectiveness. 4. Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements. 5. Facilitate harmonization and consistent implementation of Quality Systems and procedures at site, in alignment with Global Quality policies\standards. 6. Ensure market complaints, failures, deviations are investigated and corrective and preventive actions are implemented with adherence to timelines 1. 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 2. Monitor industry trends/issues faced internally and identify scope for improving Site quality management and processes. 3. Ensure compliance to regulatory requirements on product, process and release procedures. 4. Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year. 5. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment. 6. Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies. 7. Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements Travel Estimate Low Job Requirements Educational Qualification B.Pharm / M.Pharm Experience Tenure : 20 to 22 Yrs Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer:

A QA executive in the Freshalicious Super Bazaar Pvt Ltd is part of a QA team responsible for managing factory level Food safety management system. Line manage, food safety team to implement FSMS . Activities would include but not limited to implementing SOPs, evaluation of process, audits, testing methodology to meet regulatory compliance, documentation and training. They will design and develop quality procedures as required by the operations and ensure that production is maintained at such standards. Monitor and report quality KPI s. Quality Assurance team member will participate in activities to monitor, operate and provide technical support to the above-mentioned activities and work to produce safe products as per fssai and set organisational fsms norms. Job Description: Broad Area - Quality Assurance Factory Operations/Private Label/ Retail : Establishing and implementation of all standard food safety parameters mandated by the internal quality policy of the company and regulatory authorities. Supervise the Vendor staffs and provide guidance and feedback of the respective location. Oversee all product development procedures to identify deviations from quality standards Be on the lookout for opportunities for improvement and develop new efficient procedures Ensure timely corrective action on non-conformities appearing in the system and institute preventive actions to eliminate recurrence of non-conformities. Responsible for creating/ monitoring & improvement of food safety documents like Manuals, SOP, SSOP, work instructions, formats, Quality Control Plans, Master cleaning schedule, Master sanitation schedule & Area line clearances for Retail & Vendors Responsible for documentation management of RM Specifications, PM Specifications, FG specifications, Audits reports, GMP, COA reports, Formats, SOP, Inspection reports and Manual. Understand customer needs and requirements to develop effective quality control processes. Set requirements for raw material or intermediate products for suppliers and monitor their compliance. Will assist in data analysis and preparing reports on food quality status to relay to top management. All Private label vendors auditing/documentation verification & assist the procurement team in on-boarding with the procurement team Production witnessing & verifying the RM used & FG packed for the private label products Ensuring that the products packed are as per our supplied specifications All Customer Complaints for Private label products to be addressed & RCA & CAPA to be done for the same Maintaining Vendor Relationships along with the proposed activities Retail Audits within & outside the city Corrective & Preventive actions to be suggested for Gap analysis for audits Quick Commerce partners complaints to be addressed & provide with RCA & CAPA for the same Day to day reporting to top Management Customer complaint handling: Will support CS team in review and respond to customer complaints related to Private Label products and feed back to respective departments. Will be in charge reviewing of RCA & corrective action for the quality complaints related to Private Label products & Retail for respected geos. Weekly and Monthly Customer complaint review and identify key area for scope of Improvement and prepare action Plan with all stakeholder Other Requirements: Some travel required with occasional outstation travel for partner institution research programmes/ training field staff/ QA implementation/Vendor improvement program at different location or training purposes. Fieldtrip/Travel for the purpose of internal audits and supplier audit. Should possess a license & two wheeler to travel for some vendor location Should be conversant in computer skills. Any other duties or deputation to meet the overall food safety and quality assurance objectives of the company.

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR To carry out CIP & SIP of the vessels related to compounding and flitration area. Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder Preparation and periodic revision of SOPs related to compounding area. Responsible for the co-ordination with cross functional departments like QA,QC, warehouse Engineering, HR and administration for the day to day activities. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

The 3rd Party Quality Assurance Executive/ Senior Executive/Asst.Manager is responsible for overseeing and ensuring the consistent application of quality assurance protocols and food safety standards within a designated food manufacturing plant. This role acts as an impartial third-party, providing expert oversight, independent verification, and continuous improvement recommendations to enhance product quality, safety, and regulatory compliance. The ideal candidate will possess a strong background in food science, quality assurance, and a thorough understanding of relevant food safety regulations (e.g., FSSAI, HACCP, GMP, ISO 22000). Key Responsibilities: 1. Quality Assurance and Food Safety Oversight: * Conduct regular, unannounced inspections of production lines, raw material storage, finished product warehousing, and all operational areas to ensure adherence to established quality and food safety standards. * Verify the implementation and effectiveness of the plants HACCP (Hazard Analysis and Critical Control Points) plan, PRPs (Prerequisite Programs), and OPRPs (Operational Prerequisite Programs). * Monitor and verify critical control points (CCPs) and ensure appropriate corrective actions are taken when deviations occur. * Review and approve incoming raw materials, packaging materials, and finished products against specifications. * Oversee the calibration and maintenance of quality testing equipment. * Ensure proper sanitation procedures are followed throughout the plant. 2. Auditing and Compliance: * Perform internal audits (product, process, system) to identify non-conformities and areas for improvement against client specifications, internal standards, and regulatory requirements (e.g., FSSAI regulations, local health codes). * Assist the plant in preparing for and participating in external audits (e.g., regulatory, customer, certification audits). * Ensure compliance with all applicable national and international food safety regulations and standards. * Maintain thorough and accurate documentation of all audits, inspections, and quality records. 3. Data Analysis and Reporting: * Collect, analyze, and interpret quality data (e.g., sensory analysis, microbiological testing, physical attributes, complaint data). * Generate detailed reports on quality performance, non-conformances, and corrective actions for the premises. * Identify trends, root causes of quality issues, and recommend preventative measures. * Present findings and recommendations to plant management and stakeholders. 4. Corrective and Preventive Actions (CAPA): * Investigate customer complaints, internal non-conformances, and quality deviations thoroughly to determine root causes. * Collaborate with plant personnel to develop and implement effective corrective and preventive actions. * Follow up on the effectiveness of implemented CAPAs to ensure sustained improvement. 5. Training and Development: * Provide guidance and support to plant personnel on quality assurance and food safety best practices. * Identify training needs and potentially assist in the delivery of training programs related to food safety, GMPs, and quality control. 6. Continuous Improvement: * Proactively identify opportunities for process optimization and quality enhancement within the plant. * Work collaboratively with plant management and production teams to implement improvement initiatives. * Stay updated on industry best practices, emerging food safety risks, and regulatory changes. 7. Relationship Management: * Maintain a professional and collaborative working relationship with all levels of staff at the food plant. * Act as a liaison between [Your Company and the 3P Vendor to ensure clear communication and alignment on quality objectives. Qualifications: Education: Bachelors degree or Master s degree in Food Science, Food Technology, Microbiology, Chemistry, or a related scientific field. Experience: Minimum 5 years of progressive experience in Quality Assurance/Food Safety within the food manufacturing industry. Experience working in a 3rd party auditing or consulting role is highly desirable. Strong understanding of various food processing technologies. Certifications (Preferred): HACCP Certification Internal Auditor training for food safety management systems. Skills: Good knowledge of food safety principles, quality management systems, and regulatory requirements (FSSAI, etc.). Strong analytical and problem-solving skills with attention to detail. Good communication (written and verbal) and interpersonal skills. Proficient in using quality management software and Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently, make sound decisions, and manage multiple priorities. Strong ethical conduct and integrity. Ability to travel as needed (if applicable, e.g., to different plant locations).

Job Category: Quality Job Family: Plant Quality Assurance Job Description: To look after the overall quality parameters of raw milk What you ll Do: Testing of Raw Milk Quality as Dairies Industries. Preparation of Chemicals & Standardization Monitoring of critical parameters and hygiene practices in FMR Maintaining GMP & GLP requirements as per the Customer Maintaining of all log sheets as per the ISO STD. Coordination with customer representative, procurement, and production Equipment Calibration, Verification & maintain the records , physical inspection at the time of sampling Manpower adjustment, handling, and monitoring Update and coordinate daily changes, new things Track and investigation of quality issue LIMS, Oracle , etc. activities What you need to succeed: Bachelor s / Master s degree in Dairy Technology, Food Science, Chemistry, or related field. 3-6 years of experience in milk testing and dairy quality systems. Knowledge of ISO, FSSAI, and customer-specific quality requirements. Proficiency in laboratory instrumentation and data management systems

JOB DESCRIPTION Designation: Research Associate (9-I) or Senior Research Associate (9-II) Job Location: Bangalore Department: BBRC PD ARD - GMP About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- a strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Job Purpose (1-2 Lines): Analytical Research and Development working on Analytical GMP testing (AGT), and Syngene BMS Laboratory (SBL) stability programs Key Responsibilities: Testing of samples (drug substance and drug product for release testing and stability) using chromatographic, dissolution, and wet analytical techniques under a GMP environment following cGMP practices Analysis of API clinical campaign samples manufactured in Syngene pilot plant Qualification or requalification of API reference standards. Performing instrument calibration and qualification Performing method validation, and method transfers Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab Deliver analytical results within the established windows and as per applicable guidelines Compliance & implementation of quality systems Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Electronic lab notebook documentation Miscellaneous lab responsibilities Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II; Technical/Functional Skills: The candidate should have a good educational and theoretical, analytical chemistry background Good knowledge of analytical techniques The candidate should understand instrument calibration, qualification, method validation, and analytical testing Good understanding of documentation as per GxP requirements (electronic notebook) The candidate should have good proficiency in MS office tools Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred. Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II Behavioral Skills: Strong commitment toward work and a high level of dedication, enthusiasm, and motivation Good speaking-listening-writing skills, attention to detail, proactive self-starter Ability to work successfully in a dynamic environment Should be able to work in a team and flexible for working in shifts. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

JOB DESCRIPTION Job Title: Executive or Senior Executive Job Location: Bangalore Job Grade: Level 9 (9-I or 9-II) 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 3-6 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)

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with the lens of ensuring they are in line with applicable laws and critical industry practices. Providing legal guidance to, and working closely with Compliance, Business and other stakeholders, in this regard. Drafting, reviewing, negotiating, and closing contracts (relating to the payments/ financial services business, banking contracts etc.) with the internal and external stakeholders, with a view to protect the organization against any legal exposure and to minimize liability. Provision of legal advice in framing/ review of policies, and other internal and external documents. Staying updated on the regulatory environment; identify, interpret, and analyse existing and new legislations/ amendments/ notifications that may impact business; and basis its applicability and implications, bring it to the notice of appropriate internal functions as required. Advise and assist all stakeholders including Compliance and Business on both, ongoing legal risks and anticipated/ new legal risks arising by virtue of new laws or regulations. Internal process Adhere to timelines in reviewing and vetting all documentations, including agreements. Follow up with internal stakeholders, including business leads,for time bound closure of agreements;provide advice in course corrections; escalate when required. Monitor the timelines for submission of applications pertaining to licences (new and renewals) to regulatory authorities and ensure timely escalation where required. Learning Maintain a database on applicable laws comprising FAQs, dos anddontsas a ready reference. Keep a track on the latest lawsand notifications (including all notifications issued by the RBI), and proactively advise the management and business about such laws/ amendments and its implication on business, and accordingly suggest changes in process/ procedure. PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles) Insurance Benefits - Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance Wellness Program - Employee Assistance Program, Onsite Medical Center, Emergency Support System Parental Support - Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Higher Education Assistance, Car Lease, Salary Advance Policy Working at PhonePe is a rewarding experience! Great people, a work environment that thrives on creativity, the opportunity to take on roles beyond a defined job description are just some of the reasons you should work with us. Read more about PhonePe on our blog. Life at PhonePe PhonePe in the news

JOB DESCRIPTION Job Title: Technical Training Associate Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) 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. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit 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: Deliver training for GxP courses, including GMP, GDP, DI, and personal hygiene. Act as LMS administrator in SAP SuccessFactors for tasks like SCORM creation, exam unlocking, course assignments, ILT creation, assignment profile setup, addition of instructors, AICC content uploads, item ID creation, and other LMS-related activities. Update training modules and questions in the LMS. Conduct annual LMS upgrades based on SAP system updates. Coordinate with training coordinators and stakeholders across SYNGENE for training compliance Revise SOPs and provide training to departmental training coordinators. Maintain and update the training schedule, including monthly training and the annual training calendar. Manage GTR, attendance updates in LMS, and external training data entries. Develop and deliver training for VR modules. Monitor training files for client and regulatory audit compliance, ensuring necessary documentation. Collaborate on external training initiatives with organizations like USP India, PDA, and ISPE. Verify the effectiveness of SOPs in EDMS to align with world-class standards. Conduct monthly spot checks for department compliance as per the training SOP checklist. Compile MES data for QGF, QMR, risk registers, and quality town hall presentations. Prepare pending reports for the training department and summaries of overdue signoffs. Role Accountabilities: Accountable for the above-assigned role Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 3-6 Years Demonstrated Capability: as per the above role Education: Any master s degree, M. Pharma/ M. Sc. Will be preferred Experience: 3-6 years Skills and Capabilities: LMS, EDMS, Track-wise, articulate 360, Microsoft Office, self-motivated, able to communicate in English Education Any master s degree, M. Pharma/ M. Sc. Will be preferred Equal Opportunity Employer .

JOB DESCRIPTION Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru 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. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit 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 Core Purpose of the Role: This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing. Role Accountabilities: Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable. ). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs. Verify the product details, batch no. , quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs) Must have handled clients Expertise in review of Master Batch Record, Batch Record and Analytical Documents Knowledge on Good Documentation and laboratory practices Good coordination among CFTs Skills and Capabilities Expertise in handling QMS Activities Good knowledge about project related activities Client handling experience Master Batch Record, Batch Record and Analytical Document Review skills Specification and Method of analysis review Good communication skills Education MSc. Chemistry Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Job Title: QMS Coordinator Job Location: Syngene International Limited, Bengaluru 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. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit 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: This is an exciting opportunity to play a pivotal role in driving quality excellence at Syngene through the QMS function. The role offers exposure to implementing cutting-edge quality practices and refining compliance workflows, ensuring operational efficiency and regulatory readiness. It provides a platform to proactively identify improvement areas, embed quality culture across functions, and stay ahead of evolving standards in Formulations. Role Accountabilities: Drive the continuous enhancement of Syngene s Quality Management System by developing robust, in-house processes that reduce dependency on external audits and consultants. Begin by performing an in-depth review of existing QMS frameworks and regulatory guidelines. Design and implement optimized quality workflows leveraging digital tools and risk-based thinking. Evaluate system effectiveness through CAPA trends, and compliance metrics to identify process improvement hotspots. Based on these insights, the QMS evolved to support readiness for global regulatory expectations. Syngene Values: All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience: Candidate should have 9 -12 years exposure in Oral Solid Dosage forms and injectable facility quality assurance activities. Candidate should have USFDA audit exposure. Establish good Interpersonal skills with cross-functional teams. Skills and Capabilities: Expertise in handling multiple expression platforms Capable of thinking scientifically to address complex problems and develop solutions Work as a team and have collaborative mindset Good communication skills Education: B. Pharm/ M. Pharm Job Description: Key Responsibilities: Create/ revise procedures and other related documents as applicable. Review of SOPs, IOPs, EOPs, Protocol and Reports for Formulation Facilities. Handling of Change Controls, Deviations, CAPA, Customer complaints, Self-Inspection and Internal Quality Audit. Perform Trending of Change Controls, Deviations, CAPA, LIR and Customer complaints. Ensure compliance with observations of Self Inspection, Internal Quality Audit and client or regulatory audit. Perform activities related to SAP. Vendor qualification of raw material, packing material, consumables, contractors engaged in manufacturing pertaining to GMP manufacturing with respect to vendor questionnaire verification, vendor audit and compliance report verification for approval. Approval of vendors by desktop and site audits. (As required) Review of Risk assessment document from the vendor. Verification of vendor rating documents from the purchase. Inspection of RM, PM and consumables for any damage and discrepancy possible during receipt, storage dispensing and handling of these materials in warehouse. Review of vendor Quality Agreement. Preparation and updation of requalification schedule for Manufacturers. Archival of documents. Issuance of annexures and logbooks. Provide data for QMR and QGF meeting. Provide line clearance to Dispensing, Manufacturing and Packaging area. Provide dispatch clearance for Shipment. Preparation & Review of RSG report. Review and Approval of Calibration Certificate. Review of executed BMR and BPR. Responsible for review and release of Batches. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Designation: AQA Reviewer Job Location: Bangalore Department: Analytical Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scienti fi c services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scienti fi c problems, improve R&D productivity, speed up time to market and lower the cost of innovation . Key Responsibilities: Review of analytical raw data (through ELN / manual) generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and speci fi cation. Ensuring, verifying, and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP. Review of Outsourced analytical report. Review of logbooks with respect to all activity performed in the lab. Responsible for taking any other job allocated by Department Head / Department In charge. Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document. Responsible to ensure review and release of raw material and packing material in LIMS/SAP. Responsible to ensure review and release of cleaning samples, inprocess samples, calibration reports and standard qualification reports. Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents. Review the documents for completeness, compliance to good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable Review of all the tests as specified in the specification/Request for analysis /validation protocol/sampling protocol have been carried out Review of all supporting documents like chromatograms, balance print outs, Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable Review of the test results in COA against specification along with other relevant sample information before approval. In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory. Ensuring of conducting regular GMP rounds at Quality Control Laboratory. Involving in the Laboratory incident investigation, review, and approval. Educational Quali fi cation: M. Sc (Life science / Chemistry)/ M. Pharm Technical/functional Skills: Good exposure in Enterprise Applications like SAP, Learning Management Systems, Trackwise, and Analytical laboratory Applications like Chromatography and Non-chromatography data Management. Well versed in electronic data audit review. Good Knowledge on handling the application software. Establish good Interpersonal skills with cross-functional teams. Experience: 9 to 12 Years experience in life science industry. Behavioural Skills: Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be able to work in team and flexible for working in shifts. Should be a focused employee. Equal Opportunity Employer: .

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

Key Responsibilities - 1. Quality Management System (QMS) : Develop, implement, and maintain QMS in line with industry best practices and compliance standards. Ensure quality standards are met as per the standards followed in ISO, EIA, BIS, FSSAI etc 2. Regulatory Compliance : Ensure that all products and processes comply with government regulations and safety standards. Conduct regular audits and inspections to maintain high standards of hygiene and safety. 3. Product Testing and Analysis : Oversee the testing of raw materials, in-process items, and finished products to ensure consistency and quality. Ensure quality of raw milk received to final finished products for the market Support the processing activities for ensuring quality in process by coordinating with production daily. Check and control quality of water used for processing activities. Manage and review laboratory results and adjust processes accordingly. 4. Quality Assurance : Work with procurement and suppliers to ensure incoming raw materials meet established quality standards. Create systems in assurance for ease of process administration such as standard procedures and testing procedures for critical parameters which decide the production process. Create systems in Quality inspection and control for reducing the time of testing and critical metrics to be monitored for process compliances [Go or NO Go decisions] Evaluate cost of quality Vs cost of production and take decisions for reprocessing or draining the milk recovered due to leakage in packing and market returns. Keep control samples of finished products in cold storage / refrigerators with batch numbers as a batch sample and the reports till the expiry of the product. Coordinate with purchase for purchase of required equipments and service of existing machineries/ tools / equipments used in quality Coordinate with purchase and ensure the indents raised by the department on requirements of chemicals, testing consumables etc., Coordinate with BMC manager on improvisations required for receiving better quality of milk based on RMRD quality reports. 5. Documentation and Reporting : Maintain accurate documentation for all quality control activities and audits. Prepare detailed reports for management, highlighting quality trends, issues, and resolutions. Prepare schedules for maintenance on cleaning process of critical pipelines if indicated by microbiological reports. Take action and restore them to production jointly. Ensure the cycles for recalibration of all testing and measuring equipment are done in timeCollect the log of milk receipt, opening and closing stocks and testing and quality clearance and validate the same for ageing of the milk every day. Customer Complaint Management : Investigate customer complaints related to product quality and implement effective corrective measures. Keep watch on the process parameters and ensure that the SOPs are followed. Analyse the data and identify solutions or measures to improve the quality of the process delivered. Attending and eliminating the repeated customer complaints. Desired Candidate Profile 10-15 years of experience in Quality Assurance/Quality Control in FMCG industry, preferably with expertise in dairy products. MS/M.Sc(Science) degree in relevant field such as Dairy Technology or Food Technology.

Role & responsibilities :- 1) Knowing HPLC/ GC, Dissolution, UV, FT-IR, Potentiometer Troubleshooting, Calibration, Method Validation and Method Development. 2) Perform the analysis individually for In process and stability samples as per plan. 3) Follow Good manufacturing practices, Good laboratory practices and Good documentation practices in ADL. 4) Method Development of new products for test like Cleaning, Assay, Residual solvent, Dissolution & organic impurities. 5) Preparation, storage and usage of Volumetric / Reagent / Standard / Indicator solution. 6) Perform the calibration and verification of all instrument / equipment as per calibration scheduled. Preferred candidate profile :- Post-Graduation in M.Sc. Analytical Chemistry, Organic Chemistry From the Pharma Background Industry. Knowing GCMS, LCMS is added advantage Perks and benefits :- As per the company Policy

Role & responsibilities Experience of handling licensing authority. Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc). Managing Document Control system-Tracking Document changes, Create Quality. Manual, SOPs (Standard operating Procedure),maintain computerized and written records/reports. Responsible in implementing companys quality system in compliance with regulatory body. Ensure requirements of licensing authorities and accreditation bodies. GAP analysis , Risk assessment. Working as a management representative. Assure work process improvement and problem solving. Conduct Quality Training. Conduct/perform Internal Quality Assessment. Coordinate workplace safety process improvements and safety audits. Conduct Internal Audit ,prepare audit report ,initiate management review meeting. Initiate CAPA for the deviation. Preferred candidate profile Experience in ISO. 25 years in quality or regulatory affairs in a healthcare segment. Must have Technical & Regulatory Knowledge. Quality & Compliance along with Technical skills. Communication, Critical Thinking, Organizational, Attention to Detail.

Role & responsibilities Experience of handling licensing authority. Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc). Managing Document Control system-Tracking Document changes, Create Quality. Manual, SOPs (Standard operating Procedure),maintain computerized and written records/reports. Responsible in implementing companys quality system in compliance with regulatory body. Ensure requirements of licensing authorities and accreditation bodies. GAP analysis , Risk assessment. Working as a management representative. Assure work process improvement and problem solving. Conduct Quality Training. Conduct/perform Internal Quality Assessment. Coordinate workplace safety process improvements and safety audits. Conduct Internal Audit ,prepare audit report ,initiate management review meeting. Initiate CAPA for the deviation. Preferred candidate profile Experience in ISO. 25 years in quality or regulatory affairs in a healthcare segment. Must have Technical & Regulatory Knowledge. Quality & Compliance along with Technical skills. Communication, Critical Thinking, Organizational, Attention to Detail.

Perform routine Environmental Monitoring activities: viable and non-viable monitoring, surface monitoring, personnel monitoring. Good knowledge of cleanroom classification (ISO 14644), Good Manufacting P and EM requirements Ability to prepare and execute validation protocols and summarize reports Skilled in microbial monitoring techniques and aseptic area behaviour. Strong documentation, audit readiness, and data integrity practices

Role & responsibilities Ensure adherence to SKU wise Production plans Manage Line Operation Operating the packaging machines Ensure adherence to CQA Quality Standards Manpower handling and Optimize Manpower utilization Ensure Online SAP transactions Ensure 5S and GMP in Plant Coordinating Production executive in TPM and other related process All Mechanical Equipment in Good safe working conditions Attending machine related Mechanical Breakdowns Attending utilities related Mechanical Breakdowns Service time for attending the faults Maintaining service level for no production loss hours Adherence to PM preventive maintenance schedule Preferred candidate profile Candidate Preferred from FMCG Industry This is a shift-based role, and candidates must be willing to work across all three shifts. Prefer hands on experience of handling Production activities. The job is located in Sanand, Ahmedabad. Please apply only if you prefer this work location.