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2.0 - 6.0 years

4 - 6 Lacs

Pune

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Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

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8.0 - 10.0 years

7 - 9 Lacs

Pune

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Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

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4.0 - 8.0 years

6 - 10 Lacs

Medak

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Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

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2.0 - 4.0 years

4 - 6 Lacs

Medak

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Job Description Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelors degree

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5.0 - 10.0 years

7 - 12 Lacs

Bengaluru

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Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

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4.0 - 8.0 years

6 - 10 Lacs

Mumbai

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The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take the lead and well give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities. For our business, for clients, and for you The Role: Understand the global outsourcing policy and framework and support the Global Outsourcing Team in ensuring the business comply with this and supporting in annual refresh of policy and process. To join regular calls and meetings with the Global Outsourcing Team to shadow and learn the business and operating model from an outsourcing perspective. Support the regulated businesses across Apex with maintenance of the Nexus Assurance Navigator system. Take responsibility and ownership of Nexus Navigator and validation and integrity of data within. Work with various technology stakeholders across the business to ensure there is accurate and seamless data feeds and support with development of reporting in and out of the platform. At as project manager for any system, data or reporting projects and initiatives Support the regulated businesses across Apex with Outsourcing tasks within the platform Perform analytics on data outputs Create reports from excel outputs and support with development of dashboards to present data Support the India Outsourcing Lead, GSC and local businesses with maintenance of the Nexus Assurance Navigator system and to support with preparation of reports. Support the India Outsourcing Lead and Local MGT with amending, preparing and reviewing outsourcing spreadsheets Support the India Outsourcing Lead and Local MGT with signing of all outsourcing documents and uploading into the system Support with Nexus Assurance on-going development and system enhancement projects. Act as super user on Nexus, providing support globally and over time supporting with delivering training and guidance on the system Support with various outsourcing projects with internal stakeholders. Maintaining outsourcing registers in excel and on systems. Preparing and presenting quarterly and ad-hoc reporting packs. Assisting in audits including internal audits and risk assessments and reviews from an outsourcing perspective. Maintaining and updating trackers internally and ensuring data integrity and confidentiality of internal information. Be a member of the Global Outsourcing working group and take part in joining each of the initiatives/project teams that this group are tasked with. Preparation of annual due diligence reports Quality assurance and control The Skills: Strong communication and drafting skills including drafting of presentations and reports and supporting in writing policies and procedures Ability to learn and grasp new compliance/risk/regulatory concepts and understanding these across multiple global jurisdictions within the business. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Very strong MS Office skills (including MS Excel Outlook, MS Word, MS PowerPoint) DisclaimerUnsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.

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7.0 - 11.0 years

7 - 11 Lacs

Bengaluru

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Skill required: IX Intelligent Asset Management Operations - Asset Data Management Designation: Asset Performance Mgmt Specialist Qualifications: Any Graduation Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Role:Occupational HygienistThe Occupational Hygienist serves as a technical expert on industrial hygiene, providing guidance on regulatory requirements, safety compliance, and best practices while analysing complex data to inform occupational exposure limits and support litigation and industry studies. This role will support occupational hygiene programs across Client assets, coordinating health resources for projects and turnarounds, and offering direct occupational health support to business units. The role is part of the Health, Safety and Environmental team at the Client. What are we looking for Bachelor s degree in industrial hygiene, occupational health, safety, or a related field from a recognized (AICTE) universityMinimum of 5 years of experience in occupational hygiene, preferably in the oil and gas industry.Proficient in using various OH software and analysis of health and safety data. Roles and Responsibilities: Act as a technical resource and expert consultant for Client by being knowledgeable in regulatory industrial hygiene requirements, including interpretation, applicability, best practices, and guidance.Provide counsel and support for safety and health compliance concerns, including appropriate management and workforce engagement.Analyze complex data sets for detailed studies, including support for litigation, industry studies, and to inform internal occupational exposure limits (OEL) development.Provide guidance, implement and manage Client occupational hygiene and occupational health programs across international operations and corporate organizations to recognize, eliminate, and control occupational health hazards and diseases.Provide occupational health support to business units and plan, communicate, and remotely monitor field activities including turnaround, project, and/or routine operations. Provide input into Hazard Identification (HAZIDs), design of exposure assessments, occupational health equipment calibration and repairs, noise surveys, legionella testing, radiation checks, and hazard communications as needed.Audit performance against requirements and recommend practical corrective actions or solutions. Qualification Any Graduation

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2.0 - 10.0 years

6 - 7 Lacs

Bengaluru

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Watson Pharma Private Limited. is looking for Medical Writing Associate to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

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0.0 - 1.0 years

2 - 3 Lacs

Ahmedabad

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Dishman Carbogen Amcis is looking for Trainee - API QC to join our dynamic team and embark on a rewarding career journey Assist in testing raw materials and API products Follow SOPs and perform laboratory quality checks Document observations and maintain equipment Support regulatory and GMP compliance activities

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1.0 - 3.0 years

2 - 6 Lacs

Navi Mumbai

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Job Summary: The Production Specialist in the dairy industry is responsible for overseeing and optimizing daily operations in milk and dairy product processing. This role ensures production targets are met efficiently, hygienically, and in compliance with quality and safety standards. Key Responsibilities: Supervise and monitor daily production activities including milk reception, pasteurization, homogenization, and packaging. Ensure adherence to Good Manufacturing Practices (GMP), HACCP, and other food safety and quality systems. Coordinate with Quality, Maintenance, and Supply Chain teams to ensure smooth operations. Monitor key production parameters (yields, losses, efficiency) and drive improvements. Maintain accurate production records and documentation. Implement and support continuous improvement initiatives (lean manufacturing, 5S, Kaizen). Ensure optimal utilization of manpower, machines, and materials. Support the commissioning and validation of new equipment or processes. Train and guide production operators and staff on SOPs and safety practices. Troubleshoot operational issues and escalate unresolved problems. Qualifications: Bachelor’s degree/Diploma in Dairy Technology, Food Technology, or related field. 1–5 years of experience in dairy processing or production (milk, curd, paneer, ghee, etc.). Knowledge of food safety standards (FSSAI, ISO, HACCP, etc.). Strong analytical and problem-solving skills. Proficiency in MS Office and ERP systems (SAP preferred). Good communication and team coordination skills.

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3.0 - 6.0 years

10 - 20 Lacs

Hyderabad

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To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause. To use Rubrics template for investigation report writing. To provide appropriate support to site in preparing for or during regulatory inspection for investigations. Qualification B Pharmacy Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

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2.0 - 4.0 years

5 - 12 Lacs

Navi Mumbai

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Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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3.0 - 6.0 years

2 - 6 Lacs

Bengaluru

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Role & responsibilities Experience: 3-6 years Specialization: soft gel Key Responsibilities: Formulation Development : Design and optimize Softgel formulations for pharmaceutical and nutraceutical applications. Process Optimization: Conduct proof-of-concept studies, scale-up trials, and technology transfers. Regulatory Compliance: Ensure formulations meet ICH, FDA, and GMP guidelines. Analytical Coordination: Work with analytical teams to develop and validate testing methods. Troubleshooting: Address formulation challenges related to solubility, stability, and encapsulation. Documentation: Maintain accurate records, prepare technical reports, and contribute to regulatory submissions. Collaboration: Work with manufacturing, quality assurance, and regulatory teams to ensure seamless product development. Qualifications: Education: Masters degree (M. Pharm / industrial Pharmaceutics) or equivalent in Pharmaceutical Sciences Experience: 3 to 6 years in Softgel formulation R&D. Technical Expertise: Strong knowledge of gelatine-based and alternative encapsulation technologies. Regulatory Knowledge: Familiarity with ICH guidelines, GMP, and regulatory requirements. Analytical Skills: Ability to interpret analytical data and troubleshoot formulation issues. Communication: Strong technical writing and presentation skills. Preferred candidate profile Experience in Soft Gel

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8.0 - 10.0 years

6 - 10 Lacs

Noida, Hyderabad, Bengaluru

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Req ID: 309049 We are currently seeking a QA - Core Banking Data migration to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Job TitleQA Data Migration "“ Core Banking (Transact) : We are looking for a highly skilled Quality Analyst with expertise in the banking sector, specifically in Core Banking (Transact) along with migration experience. The successful candidate will be responsible for ensuring the quality and integrity of data during migration from legacy systems to new platforms. Key Responsibilities: Develop and execute test plans, test cases and test scripts to ensure data integrity, accuracy and completeness during migration. Work across multiple functional projects to understand data usage and implications for data migration. Identify, Document and track data quality issues and collaborate with cross functional teams to resolve them. Validate data migrated to new systems, ensuring it meets business requirements and free from defects. Identify, report and track defects found during testing and collaborate with development teams to resolve them. Skills and Qualifications: 8-10 years of overall experience with a minimum of 3+ years as Core banking QA. Proven experience as a Quality Analyst in the banking sector. In-depth knowledge of Core Banking Transact and migration processes. Familiarity with agile methodologies and project management principles. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Ability to work independently and as part of a team.

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8.0 - 10.0 years

8 - 10 Lacs

Tarapur

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Role & responsibilities Monitoring training compliance of site employees on various areas like GMP, Functional, SOP, On Job Training, Refresher training etc. Handling of regulatory audit (USFDA, WHO, ANVISA, PMDA and other domestic audits/visits) Execution of task as per SOP (Specially Creation of Annual planner and execution of same, training effectiveness check, training content approval, job profile changes related, trending of human errors etc.) Handling of day to day and annual training documentation To ensure Curriculum compliance of site employees and escalation To facilitate Site Induction, to ensure training of new joiner and monitoring of onboarding days Please share resume with job title on below Mail ID : gaurangikudavkar@lupin.com

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5.0 - 7.0 years

3 - 6 Lacs

Ahmedabad

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Supplier qualification Audit Management Documents and Reporting Regulatory Compliance Supplier Development Risk Management

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2.0 - 7.0 years

3 - 8 Lacs

Ahmedabad

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Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD – Manufacturing / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

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5.0 - 10.0 years

5 - 9 Lacs

Ahmedabad

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Maintain QMS & ensure compliance with GMP standards across the plant Conduct audits, compile reports, approve vendors for RM & packaging Review documentation like SOP, BMR, BPR, APQR, etc Handle deviations, complaints, OOS reviews, and implement CAPA Required Candidate profile Experience facing audits in the pharma intermediates/API/bulk drug industry only; formulation experience not relevant Excellent communication skills for audits. Fluency in English & MS Office.

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10.0 - 15.0 years

10 - 12 Lacs

Nagpur

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Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time

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1.0 - 6.0 years

1 - 6 Lacs

Tirupati, Chennai, Bengaluru

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Role & responsibilities Aurobindo Pharma Ltd. Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Assurance (Market Complaints / QMS / Validation / IPQA) Quality Control (GMP / GC / LCMS / HPLC) 3 Experience Required: 2 7 years (pharmaceutical manufacturing) Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: Quality Assurance Key Scope • Handle Market Complaint investigations, trend analysis and regulatory responses • Maintain site QMS: Deviations, CAPA, Change Control, Audit readiness • Execute and review Equipment / Process / Cleaning Validation documentation • Perform IPQA activities: line clearance, in-process checks, batch record review • Conduct GMP & Data-Integrity training for shop-floor teams Quality Control Key Scope • Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc. • Prepare/standardise analytical methods, calibration & instrument qualification (IQ/OQ/PQ) • Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry • Investigate OOS/OOT results and implement effective CAPA • Support regulatory, customer and internal audits Common Requirements: • Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry or related) • Sound knowledge of current GMP guidelines (US-FDA, MHRA, EU, WHO) • Good documentation, investigation and communication skills • Willingness to work in shifts and collaborate with cross-functional teams How to Apply • Send you updated resume : naidupetahr@aurobindo.com • WhatsApp : 9851444337

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12.0 - 15.0 years

12 - 15 Lacs

Ambarnath

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Responsibilities: * Manage store operations, planning, and audits * Supervise warehouse team and implement GMP practices * Oversee document management and capacity planning Provident fund

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2.0 - 3.0 years

3 - 3 Lacs

Hyderabad

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Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

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2.0 - 4.0 years

1 - 5 Lacs

Mahad

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QMS documents and issuance of docs. Review of Docs. Identify and report quality issues and deviation. Handling of change control, incidents & deviation. Line clear & dispatch activities. Document distribution and control.

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2.0 - 5.0 years

2 - 5 Lacs

Ankleshwar

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Job Title: Officer/Senior Officer Location: Ankleshwar Experience: 2-5 Year Department: Production Role and Responsibilities: Production Operations Check labels and verify identity of raw materials, packing materials, and solvents before use. Maintain appropriate storage conditions for raw materials and intermediates in the plant. Execute batch processes as per approved Batch Production Records (BPRs). Follow instructions from Shift In-charge or Production Manager for batch charging and monitoring. Monitor and maintain process parameters during manufacturing. Complete allocated tasks within the stipulated timeline with accuracy. Ensure contamination-free production and proper packing/repacking of materials. Adhere to proper gowning, hygiene, and entry protocols for classified production areas. Operate plant equipment and utilities safely and efficiently. Maintain cleanliness and proper segregation in the production area as per SOP. Documentation & SAP & GDP Perform online documentation of BPRs, cleaning logs, and equipment usage records during the shift. Maintain differential pressure, centrifuge bag records, and other PP/Intermediate area logs. Update SAP transactions for material consumption, yield recording, and inventory movements. Ensure timely entries in equipment logbooks and SAP-based process entries . Label all process equipment, HDPE/fiber drums, and accessories correctly per batch and SOP requirements. Ensure Good Documentation Practices (GDP) by making real-time, legible, complete, and traceable entries in all logs and records. GMP & Compliance Guide and train workmen on cGMP practices and technical SOPs. Ensure finished product yield and quality meet predefined specifications. Participate in internal audits, regulatory inspections, and SOP reviews. Perform calibration of instruments such as weighing balances and pH meters. Keep equipment status boards updated and follow QMS standards. Safety & Environmental Compliance Understand MSDS of all materials handled and ensure safe handling practices. Supervise plant operators to ensure chemical and equipment handling safety. Use scrubbers and proper exhaust systems to control emissions and avoid air pollution. Coordinate with the EHS department for required safety permits and compliance. Wastage Reduction Prevent solvent/material spillage and reduce wastage through proper process control. Ensure utilities (valves, pumps) are turned off when not in use to conserve resources. Cross-Functional Coordination Coordinate with QC for sample analysis and batch release. Liaise with engineering for breakdown and preventive maintenance activities during shift. Work closely with Warehouse, QA, and EHS departments for smooth operations. Interested candidate can share there cv at meet.chauhan@cadilapharma.com .

Posted 6 days ago

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3.0 - 4.0 years

2 - 3 Lacs

Hyderabad

Work from Office

Naukri logo

Role & responsibilities i. Responsible for factory GMP and food safety management system. ii. Responsible for packaging integrity, coding iii. Responsible for Recipe weighing correctness. iv. Responsible for despatch verification v. Responsible for Sampling, confirmation for packing. vi. Responsible for doing QC analysis Preferred candidate profile Science Graduate or Food technologist with experience of 3-4 years in food industry with experience in implementing food safety systems and audits requirements.

Posted 6 days ago

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