480 Lims Jobs - Page 3

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description Our Digital team at Azurity is building new capabilities utilizing cutting-edge Lead IT Systems (R, Q & RIMS) Expert. We are looking for a dynamic, change inspired, Dwell b/w multiple system, Individual self-driven hands-on Lead IT Systems (R, Q & RIMS) Expert. Team Member Ability to work onsite during flexible hours to support India, US and EU operations Job Summary We are seeking a dynamic and versatile Lead IT Systems with strong hands-on experience in Research, Quality Management Systems (QMS) and Document Management Systems (DMS), coupled with a working knowledge of RIMS and Lab Systems. This role requires the ability to wear multiple hats, supporting a cross-functional pharma IT landscape that spans Quality, Regulatory, and Laboratory systems. The ideal candidate thrives in a regulated environment, collaborates across functions, and ensures systems remain compliant, validated, and business aligned. Mandatory Qualifications B.Tech / B.E. in Computer Engineering (Mandatory) M.Tech in Computer Engineering / IT (Preferred) Experience Required 8–10+ years in IT within the pharmaceutical industry Deep hands-on experience with TrackWise, Veeva Vault QMS/DMS, AmpleLogic QMS, and exposure to RIMS and Lab Systems Expertise in CSV, GxP compliance, 21 CFR Part 11, and audit preparedness Strong involvement in data migration activities and end-user training Soft Skills (Mandatory) Strong verbal and written communication Effective cross-functional collaboration (Quality, Regulatory, Lab, IT) Growth mindset with ability to handle evolving platforms Product roadmap alignment and stakeholder influence Ability to navigate complexity and ambiguity in stakeholder conversations “Multiple Hats" mindset – flexibility to contribute across QMS, DMS, RIMS, and Lab Systems as needed Ability to confidently demonstrate system functionalities and conduct user workshops Role Distribution System Domain Focus Role Expectation QMS / DMS 70% Lead ownership of workflows, validation, support, and vendor management (Veeva Vault, TrackWise, AmpleLogic), Other evolving System RIMS 20% Support submission tracking, registration workflows, and regulatory readiness Lab Systems 10% Basic support for LIMS, MPower, instrument data integrity Responsibilities Quality Systems (70%) –Core Hands-On Ownership Configure and manage QMS/DMS platforms (TrackWise, Veeva Vault QMS/DMS, AmpleLogic), Other evolving Systems Design and optimize CAPA, Change Control, Audit, Deviation, and Document Lifecycle workflows Execute and manage CSV lifecycle – URS, IQ/OQ/PQ, RTM Provide L2/L3 support, user training, SOP documentation, and handle audit readiness Coordinate directly with vendors for system updates, patching, and roadmap discussions Lead and execute data migration activities with validation and reconciliation Demonstrate QMS/DMS systems confidently to users and auditors Regulatory Systems (20%) – Supportive Ownership Administer Veeva Vault RIM or equivalent RIMS platforms Manage registration tracking, submission workflows, and HA interactions Collaborate with RA teams to gather requirements, support compliance, and maintain inspection readiness Lab Systems (10%) – Tactical Support Support AmpleLogic LIMS and MPower QC systems Monitor instrument integration and data flow (HPLC, GC, FTIR) Address sample tracking issues and logbook automation enhancements Technical Skill Set Platform Expertise Level Hands-On Scope TrackWise QMS Expert CAPA, Deviation, Audit, Change Control Veeva Vault (QMS/DMS/RIM) Expert CAPA, Deviation, Audit, Change Control Controlled docs, QMS workflows, RIMS lifecycle AmpleLogic QMS/LIMS Expert Stability, sample tracking, electronic forms MPower (QC Systems) Proficient Batch/lab workflows CSV / Validation Expert GAMP 5, ALCOA+, 21 CFR Part 11 RIMS (e.g., Veeva RIM) Proficient Submission lifecycle tracking Data Migration Proficient Legacy to new platform migration, reconciliation Training & Demos Proficient Conducting user workshops, confident system walkthroughs Audit Readiness Expert System readiness, evidence generation Service Tools Proficient JIRA, ServiceNow Instrument Integration Intermediate Empower, Agilent, OpenLab Team Member is expected to wear multiple hats—flexibly contributing to QMS/DMS ownership, RIMS support, and Lab systems troubleshooting as business needs evolve. Agility, accountability, and collaboration are key to success in this hybrid role. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less

Company Description Biologics, Dr. Reddy's Laboratories Ltd Job Description Sample accession associate role: Sample management: Receiving the clinical samples from multiple locations (internal and external) with appropriate documentation. Verify sample details against accompanying documentation and report discrepancies. Cataloging of clinical samples in LIMS and storing samples in compliance with regulatory requirements. Maintain accurate records of sample receipt, storage conditions and chain of custody of all clinical samples Monitoring inventory control and proper labelling of clinical study samples. Collaborating with laboratory staff to ensure timely availability of clinical samples for analysis. Manage and dispose expired or utilized samples as per regulatory standards Management of sample accession area: Monitoring and maintaining sample accession area as per laboratory SOPs. Ensure good house keeping of the sample accession and sample storage facility as per laboratory SOPs Ensure all equipment in the sample accession area are periodically maintained as per laboratory standards Work alongside maintenance personnel and lab personnel for maintenance, calibration/validation of instruments/equipment as assigned by Lab Head. Management of reference standard: Receive and verify reference standards or drug products from the central warehouse and store in appropriate laboratory locations. Maintain appropriate documentation and collaborate with laboratory staff for issuance of the materials. Compliance and audit readiness: Adhere to GCP guidelines, standard operating procedures and regulatory requirements. Preparation of standard operating procedures as per regulations and laboratory needs. Participation in laboratory audits and ensure appropriate corrective action and preventive actions are taken for all observations. Qualifications B.Sc/B.Pharm Show more Show less

Global Lead, Laboratory Platforms & Services Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Job Summary The Global Lead of Laboratory Platforms & Services is tasked with steering the strategic direction, governance, and operational excellence of Laboratory platforms and applications for Sandoz globally. This role emphasizes enhancing platforms and applications integration and optimization to streamline organizational processes and foster digital transformation. The incumbent is responsible for overseeing teams, managing vendor relationships, and aligning platforms and applications solutions with the organization's overall objectives and industry standards. This position demands strong leadership, a forward-thinking strategy and the ability to address complex challenges while promoting growth and innovation. Your Key Responsibilities Your responsibilities include, but are not limited to: Develop and implement Laboratory platforms and applications strategy in partnership with Stakeholder success teams, aligning with organizational goals and industry standards. Manage governance and operations of Laboratory platforms and applications across regions and departments. Lead a team to deliver high-quality Laboratory platforms and applications services and support . Oversee the integration and optimization of Laboratory platforms and applications to enhance business processes and operational efficiency. Maintain strong vendor relationships to ensure the delivery of high-quality solutions and services. Comply with regulations and standards, and best practices. Drive continuous improvement and innovation to support digital transformation and growth. Develop and track key performance indicators to measure platforms and applications success. Engage with internal stakeholders to gather requirements, provide updates, and ensure solutions meet business needs. Identify and mitigate risks associated with platforms and applications operations and implementations. Provide leadership on projects, ensuring timely delivery . Leverage platforms technologies for digital transformation and process optimization . Manage budgets and resources for cost-effective solutions and maximum value . Minimum Requirements What you’ll bring to the role: 10+ years of experience in project delivery and/or application management or IT services within a multinational organization. Key skills include strategic planning, financial acumen, and team leadership. Expert knowledge and experience in key Laboratory products (e.g. LabVantage LIMS; Scitara, ) and in the implementation and operations of those. Certification in project management methods (Agile, ITIL, Prince 2, PMI) is a plus. Certification in Laboratory products is a plus. Experience with Agile/DevOps methodologies; Certification is a plus Experience in designing and operating Laboratory Center of Excellences etc. highly desirable Excellent leadership, communication, and collaboration skills. Effective communication and stakeholder management skills, with the ability to explain complex technical concepts to non-technical audiences. Strong analytical and problem-solving skills, with the ability to translate business needs into data and system requirements. Strong leadership and team-building skills, with a focus on developing talent and fostering a collaborative team culture. Proven ability to work effectively in a fast-paced, dynamic environment and drive change and innovation. Experience in managing global projects and working in diverse cultural environments. Proficiency in using advanced software tools and platforms relevant to the job. Experience with ITIL frameworks and other service management methodologies. Competencies: Platforms and applications uptime and availability Rate of successful project completions Percentage of business processes integrated with platforms and applications Cost-saving measures implemented through initiatives User satisfaction and adoption rates Compliance with regulatory and best practice standards Return on investment (ROI) from platforms and applications solutions Efficiency improvements in business operations Resolution time for platforms and applications related issues Training and development effectiveness for platforms and applications users Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! Commitment to Diversity & Inclusion (hard coded in Workday): We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com) #Sandoz Show more Show less

Job description :- Instrumental Analysis: Perform routine and stability analysis of raw materials, intermediates, and finished products using HPLC, UV-Vis Spectrophotometer, FTIR , etc. Operate and calibrate analytical instruments as per SOPs and regulatory guidelines. Troubleshoot HPLC and other lab equipment in coordination with service engineers when required. Documentation & Compliance: Prepare and maintain analytical reports, test data sheets, protocols, and logs as per GDP (Good Documentation Practices). Ensure all QC activities comply with cGMP, GLP, and other regulatory guidelines . Assist in investigation and documentation of OOS, OOT, and deviations . Sample Handling & Testing: Receive and analyze raw material, packaging material, in-process samples, and finished goods as per approved specifications. Maintain proper sample disposal records. SOP & Record Management: Review and update Standard Operating Procedures (SOPs), specifications, and analytical methods. Maintain laboratory notebooks, logbooks, equipment usage logs, and calibration records accurately. Equipment Handling & Calibration: Operate and maintain lab instruments including HPLC, Dissolution Test Apparatus, pH meter, Analytical Balance, etc. Conduct periodic calibration and qualification of instruments. Audit Readiness: Prepare and support internal and external audits (e.g., USFDA, WHO, MHRA). Maintain complete and audit-ready documentation at all times. Key Skills & Competencies: Hands-on experience in HPLC analysis and troubleshooting . Strong understanding of analytical chemistry, GMP, GLP , and ICH guidelines . Attention to detail, data integrity, and documentation accuracy. Good communication and team coordination skills. Proficiency in MS Office and LIMS (preferred). Qualifications: B.Pharm / M.Pharm / M.Sc / B.Sc (Chemistry or related field) Minimum 2–5 years of experience in QC in a regulated pharmaceutical environment . Additional Requirements: Willingness to work in shifts (if applicable). Sound knowledge of safety protocols and laboratory hygiene . Good analytical and problem-solving abilities. Familiarity with regulatory audits and compliance standards . Job Types: Full-time, Permanent Pay: ₹18,000.00 - ₹25,000.00 per month Benefits: Cell phone reimbursement Health insurance Paid sick time Provident Fund Schedule: Day shift Supplemental Pay: Joining bonus Performance bonus Yearly bonus Work Location: In person Expected Start Date: 01/07/2025

About Sun Pharma: Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5.4 billion. Supported by 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Job Summary sLIMS Implementation Specialist will be responsible for the successful deployment, configuration, and ongoing support of our Laboratory Information Management System (SLIMS). This role requires a deep understanding of laboratory workflows, strong technical skills, and the ability to work closely with cross-functional teams to ensure the SLIMS meets the needs of the organization. Roles and Responsibilities • Support in implementation and configuration of the sLIMS, ensuring alignment with laboratory workflows and regulatory requirements. • Execute the tasks defined in project plans, adhering to timelines, for successful implementation of sLIMS. • Configure sLIMS software to meet the specific needs of the laboratory, configuring workflows, and setting up user roles and permissions. • Provide training and support to end-users, ensuring they are proficient in using the sLIMS. • Troubleshoot and resolve any issues related to sLIMS performance, functionality, and integration with other systems/instruments. • Maintain comprehensive documentation of the sLIMS implementation process, including user guides and technical manuals. • Shall be aware about documentation of sLIMS application as per GMP. Shall be able to create and manage documentation of sLIMS application to ensure system is in compliance state. Qualifications and Preferences Qualifications: • Bachelor's degree in Information Technology, or Computer Science or related field. • Minimum of 4-5 years of experience in sLIMS implementation, preferably in a pharmaceutical or biotech environment. • Strong understanding of laboratory processes and workflows. • Proficiency in sLIMS software (Expertise on CaliberLIMS is preferred) • Ability to manage multiple tasks simultaneously. • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Experience with regulatory compliance requirements (e.g., FDA, GMP, GLP). Preferred Qualifications: • Advanced degree in Life Sciences, Information Technology, or a related field. • Familiarity with laboratory instruments and their integration with SLIMS • Experience with Caliber LIMS is preferred. • Good documentation skills to create and manage GxP documents. Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya. Only applications received through Jigya will be evaluated further. Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma Show more Show less

JOB DESCRIPTION Job Description for Manager-PRU Laboratory Document Number NAYA-HR-PRU-LAB-JD-01 Version / Revision 01 / 01 Date 01 / Sept / 2024 Prepared by System Coordinator Reviewed by Area Manager Approved by HOD AMENDMENT DETAILS Amendment Discard Insert Notes on Amendments No Date dd.mm.yyyy Details Rev No. Details Rev No. 1 26.08.2022 New Procedure 00 New Procedure NAYA-HR-PRU- LAB–JD-01 01.00 Organizational Change Requirement 2 01.09.2024 Revised Procedure NAYA-HR-LAB-JD-01 01.00 Revised Procedure NAYA-HR-LAB-JD-01 01.01 Annual Review done. Required changed done. JOB PURPOSE Ensure compliance w.r.t safety rules and regulation, PPE uses, good practices including calibration, and training of manpower. Thorough knowledge of PRU analysis of intermediate samples and final product. Knowledge of various grades of Products. Responsible for monitoring of SOP preparation, calibration and routine maintenance of instruments and their spares & chemicals inventory. Responsible for Safety, RIMS, NABL, IT, LIMs, training, external audits, internal audits, Proficiency testing, In-house competency monitoring. Review of international standards viz., ASTM, IP, UOP, ISO, BIS, APHA etc. and accordingly update SOPs and its implementation. Highlighting abnormalities with respect to products/intermediates samples for deviations from specifications. Assist Shift in-charge in case of exigencies and take additional responsibility of shift in-charge as per requirement. Responsible for new method/technology development, innovation/improvement in lab. ORGANISATIONAL CHART RESPONSIBILITIES RESPONSIBILITIES ACTIVITIES QUALITY MANAGEMENT SYSTEM Team Management: To achieve the team's objectives. Monitoring of testing of intermediate and finished product samples as per test methods. Ensuring the sample analysis is as per schedule, reliability of results and timely validation of results in LIMS. Acquire multiskilling proficiency to handle independently troubleshooting of instruments and training of subordinates. Monitoring of instrument calibration as per schedule, SOPs and records updation. New test methods development, SOP preparation and documentation. In absence of shift in-charge take independent charge on deputation. Assist SIC in case of emergency. Maintaining the NABL accreditation requirements. Communication with internal / external customers and provide feedback. Knowledge on various grades of Products. Customer support Ensuring availability of chemicals, CRMs and consumables. Planning & Budgeting: Annual & Facilities plan: To define a business plan that satisfies short and long term business goals Ensure compliance with latest analytical requirements. Proper usage of analytical resources Procurement of spares / consumables Monitoring of inventory of spares / consumables, chemicals and CRMs. Monitoring of calibration and maintenance as per PM schedule. Systems, Policies & Procedures: To create a management framework with the capability to achieve targeted gross margin performance. Ensuring systems and procedures as per RIMS, NABL and IQCM. Monitoring adequate RIMS / NABL documentation and records. Perform periodic internal audits as per management requirement. Knowledge of LIMS. Management : To ensure achievement of targeted outcomes efficiently and complying process design standards & Statutory regulations Authority: To correct any deviations in the process with respect to analyticalrequirements. Ensure timely release of reports and quality certificates. Ensure Calibration of instruments Highlighting abnormality/product failure Ensure release of reports on special samples from various agencies/customers. MIS : To enable timely decision making to achieve the business's targets Timely highlighting of abnormality/product failure through LIMS/telephonically. MIS report for management for critical lab results. Timely validation of results in LIMS Coordination Internal & External Coordination for troubleshooting & special samples analysis for internal customers as directed by the supervisor. Analysis of complaint samples from external customers as directed by the supervisor. Get feedback on a regular basis and address grievances. Developmental activities to support customers. Coordination with vendors for PM and calibration ENVIRONMENT MANAGEMENT SYSTEM "Systems, Policies & Procedures : To be accountable for implementation and improvement of the EMS systems, procedures & policies in respective functional operations Ensure working with all PPE's as per safety procedures at work location & accident free working. Maintain and enhance HSEF guidelines as per RIMS Ensure housekeeping of Laboratory Area including gas cylinder house and sample retention area. General awareness on Environment Management in Refinery Implementation of environment management procedures like Hazardous / Non Hazardous waste management. OHSMS HSEF - Care & Welfare: To achieve safe and healthy workplace. Authority: To stop any unsafe job on observation Ensure working with all PPE's as per safety procedures at work location & accident-free working. Follow HSEF guidelines as per RIMS. Maintain and enhance safety Standards to ensure Zero LTI Ensure housekeeping of Laboratory area including gas cylinder house and sample retention area. Ensure compatibility matrix within chemical storage. Report near miss, highlight unsafe conditions and acts. EnMS 50001:2018 Energy Management systems ISO 50001:2018 Awareness about Energy policy, significant energy uses, Energy objectives and Energy Management System. KEY CHALLENGES Observation pertaining to abnormal samples and results. Ensuring of instrument adequate performance, planning for preventive maintenance and coordination on instrument breakdown to minimise down time. Ensuring timely calibration of sophisticated instruments for reliability. Ensures sufficient spares & chemicals inventory. Troubleshooting of instruments. Compliance of NABL accreditation processes. KEY DECISIONS Made by Job holder: Accurate and reliability of measurements in time bound manner. Convey decisions pertaining to measurements in case of borderline certification. Recommendations to superior: Suggestion for procurement of spares / consumables and chemicals and maintaining inventory. Possible improvement in existing analytical practice and in operation with respect to operating parameters to meet the quality Ensure maintenance of sample containers, in particularly liquid and gas samples. Report near miss, unsafe act, unsafe condition, suggestions to improve safety, etc. INTERACTIONS Internal Interactions: Timely highlighting abnormalities pertaining to Product and intermediate sample and/or analysis to immediate supervisor. Inter dept. interactions with respect to sample coordination / transportation Coordination with subordinates and Shift in-charge/area managers. External Interactions: Timely highlighting abnormalities pertaining to Product and intermediate sample to concerned units. Interactions with respect to sample coordination / transportation with other units. Customers (Plant units) for non-receipt of samples or abnormal samples. Interaction with external vendors in regard to instrument AMC/ maintenance/spares DIMENSIONS Optimisation of use of chemicals, spares & consumables. Inventory management. Cost saving by in-house Reference Materials. Ensure safe & accident/incident free working Team Size: Direct Report: 2 to 3 Indirect Report: 5 to 6 SKILLS & KNOWLEDGE Educational Qualifications & Certifications: B Sc. (Chemistry) / M Sc. (Chemistry) Relevant (Functional/Level) & Total Years of Experience: Should have 15+ years of working experience in PRU / Petroleum Refinery / Petrochemical laboratory Functional Skills: Should have experience of coordination with various function. Familiar with testing standards Familiar with LIMS, RIMS, IQCM. Must have handled sophisticated equipments related to PRU parameters. Should have experience of instrument calibration and troubleshooting of instruments. Should have a knowledge of product, quality parameters, environment, Safety and Energy Management Behavioural Skills: Team building, Result orientation. Customer focus, operational excellence. Good learner and trainer. RESPONSIBILITIES RESPONSIBILITIES QUALIFICATIONS B Sc. (Chemistry) / M Sc. (Chemistry) Show more Show less

About Sun Pharma: Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5.4 billion. Supported by 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Job Summary LIMS Testing & Documentation Specialist will be responsible for the thorough testing of LIMS application before deployment or patch deployment. This role requires a deep understanding of laboratory workflows, strong technical & testing skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Roles and Responsibilities • Support testing of LIMS functionalities to ensure the functionality available, is working as per users’ expectation as well as it meets the approved user requirement specification. • Develop testing strategy and execute it to meet the implementation timelines. • Perform the impact assessment of newly added functions on the existing functionalities. • Rigorously test the newly introduced functionalities based on its impact on the existing functionalities. • Provide training and support to end-users, ensuring they are proficient in using the LIMS. • Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. • Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. • Shall be aware about documentation of LIMS application as per GMP. Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state. Qualifications and Preferences Qualifications: • Bachelor's degree in Information Technology, or Computer Science or related field. • Minimum of 4-5 years of experience in LIMS implementation & Instrument Integration activity, preferably in a pharmaceutical or biotech environment. • Strong understanding of laboratory processes and workflows. • Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) • Excellent testing skills, with the ability to manage multiple tasks and projects simultaneously. • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Experience with regulatory compliance requirements (e.g., FDA, GMP, GLP). Preferred Qualifications: • Advanced degree in Life Sciences, Information Technology, or a related field. • Familiarity with laboratory instruments and their integration with LIMS • Experience with Caliber LIMS is preferred. • Good documentation skills to create and manage GxP documents. Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya. Only applications received through Jigya will be evaluated further. Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma Show more Show less

About Sun Pharma: Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5.4 billion. Supported by 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Job Summary Integration Specialist – LIMS, will be responsible for the integrating various lab instruments/software with LIMS application for successfully establishing paperless environment in QC/R&D Labs. This role requires a deep understanding of laboratory workflows, Instrument connectivity techniques, strong technical skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Roles and Responsibilities • Support in QC/R&D lab instrument integration with LIMS application, at the time of LIMS implementation at various locations of SUN Pharma. • Develop and execute test scripts, and relevant documentations required as part of validation activity. • Configure LIMS software to meet the specific needs during Instrument integration activity. • Provide training and support to end-users, ensuring they are proficient in using the LIMS. • Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. • Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. • Shall be aware about documentation of LIMS application as per GMP. Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state. Qualifications and Preferences Qualifications: • Bachelor's degree in Information Technology, or Computer Science or related field. • Minimum of 4-5 years of experience in LIMS implementation & Instrument Integration activity, preferably in a pharmaceutical or biotech environment. • Strong understanding of laboratory processes and workflows. • Deep understanding of Lab Software functionality such as Empower, LabSolutions, Chromeleon. • Strong command on Data extraction / connectivity methodologies techniques for port based instruments such as balances, pH etc. • Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Experience with regulatory compliance requirements (e.g., FDA, GMP, GLP). Preferred Qualifications: • Advanced degree in Life Sciences, Information Technology, or a related field. • Familiarity with laboratory instruments and their integration with LIMS • Experience with Caliber LIMS is preferred. • Good documentation skills to create and manage GxP documents. Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya. Only applications received through Jigya will be evaluated further. Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma Show more Show less

ECO Paryavaran Laboratories and Consultants Pvt. Ltd., Mohali have required experienced Lab Analyst for Water Lab. Skill Set Education: M.Sc. (Chemistry)/ M.Sc (Environment Science)/B.Sc (PCM) 2-3 years experience in the field of chemical testing of water and pollution and environment discipline. Job Description To comply with the implemented Quality management system as per ISO/IEC 17025: 2017, satisfying the requirement of regulatory agencies, accreditation bodies. To maintain confidentiality of Laboratory’s information related to customers & organization and impartiality throughput your association with organization. To ensure Laboratory safety, Data integrity, Good Documentation practices, Good Laboratory practices are in line of implemented Quality Management System. To arrange the purchase of chemicals, glassware, CRMs and other critical consumables used in all matrix of water (Drinking, Ground, Surface, Water Used For Industrial Purpose, Irrigation Water, Package Drinking Water, Package Natural Mineral Water). Responsible for routine maintenance and annual calibration of equipment and internal calibration for all equipment's used in the analysis of all water matrixes. Sample preparation and analysis of water parameters as per relevant test method. Perform PT/ILC for all matrices in water for chemical discipline. Timely enter test results in LIMS software as per TAT in all matrices of water for chemical discipline. Maintain all log books & day to day records related to all matrices of water analysis. Any other task/activity assigned by management as & when required basis. Responsible for NABL/CPCB or any other audit for all water matrices for chemical discipline. Job Type: Full-time Pay: ₹18,000.00 - ₹28,000.00 per month Benefits: Cell phone reimbursement Health insurance Leave encashment Provident Fund Schedule: Day shift Ability to commute/relocate: Mohali, Punjab: Reliably commute or planning to relocate before starting work (Preferred) Application Question(s): Do you have experience of working in NABL accredited LAB? Experience: total work: 2 years (Preferred) Work Location: In person

Role Description Job Title: Dev III – LIMS Associate Engineer Experience Required: 3 to 5 years Qualification: Bachelor's or Postgraduate degree (BSc, BPharm, BCA, MCA, MSc, or equivalent) Location: [Add location if applicable] Job Summary We are seeking a skilled and proactive LIMS Associate Engineer with 2–5 years of experience, preferably with a strong background in Thermo Fisher’s SampleManager LIMS . The ideal candidate should have solid technical skills and hands-on experience in LIMS development, configuration, and implementation. Prior exposure to pharmaceutical laboratory processes and instrument interfacing is essential. Key Responsibilities Develop and configure SampleManager LIMS modules, including: Sample workflows Stock and instrument modules Instrument interfacing using Integration Manager Report Designer, Forms Designer, Label Designer Sample Scheduler, Batch and Lot Management Plate Handling, Stability, SQC, SM-IDI, PIMS, and Dashboards Participate in at least one or two LIMS implementation or development projects. Handle instrument interfaces, calibration, and maintenance requirements. Write and optimize SQL queries for database-related tasks. Develop and design reports, forms, and custom interfaces. Conduct thorough testing, documentation, and validation of developed solutions. Collaborate closely with QA, IT, and lab personnel to gather requirements and ensure solution alignment. Understand and follow ITIL-based support processes. Take ownership of technical challenges and resolve issues proactively. Required Skills & Experience Strong working knowledge of SampleManager LIMS and its core modules. Experience with instrument interfacing and lab equipment calibration/maintenance. Proficiency in SQL and experience working with databases. Hands-on experience in LIMS configuration and development. Familiarity with pharmaceutical lab practices and regulatory compliance. Good understanding of report and form design in LIMS. Exposure to ITIL processes and support lifecycle management. Strong documentation, testing, and validation practice adherence. Ability to work independently and take on challenges with a solution-oriented mindset. Preferred Qualifications Certification or formal training in LIMS platforms. Prior experience with stability studies, batch and lot management. Exposure to integration tools or scripting for instrument interfacing. Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less

Position Title: Executive – Quality Control Qualification And Experience M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job Overview Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India Show more Show less

Hello Everyone We are hiring for LIMS Developer Experience :8+ years Location : Remote Notice period : Immediate Skill : Core Java SQL J2EE, , JavaScript, JSP, and DHTML/Web Page development. JD : Strong skills in Core Java, J2EE, , JavaScript, JSP, and DHTML/Web Page development. Experience in Labvantage LIMS development Strong relational database knowledge and experience using either Oracle and/or SQL Server. If any one interested please share your updated cv to below mail id chandra.nama@appitsoftware.com Show more Show less

Job Title: Environmental PCR Laboratory Manager 📍 Location: Delhi Airport 🔍 Job Purpose: To manage and lead a PCR (Polymerase Chain Reaction) laboratory focused on wastewater testing at the airport. The role supports biosecurity measures and enhances health surveillance efforts, contributing to early detection and pandemic preparedness. Key Responsibilities: 🧬 Laboratory Management Lead and supervise a team of laboratory technicians. Oversee daily operations including scheduling, resource planning, and workflow coordination. Ensure compliance with lab safety protocols, regulatory requirements, and quality standards. 🧫 PCR Experimentation Execute and optimize PCR assays, including RNA extraction and purification. Troubleshoot technical issues and mentor lab staff in protocol adherence. Continuously improve procedures for accuracy and efficiency. ✅ Quality Control Implement robust quality control measures to ensure reliable results. Maintain accurate documentation of all quality control processes. Drive continuous improvement initiatives for lab operations. 📊 Data Analysis Ensure accurate data collection, analysis, and timely reporting. Interpret PCR results and support data presentation efforts. Maintain secure storage and management of sensitive lab data. 🔩 Equipment and Resource Management Manage and maintain PCR equipment including thermal cyclers. Coordinate repairs, calibrations, and preventive maintenance. Monitor inventory and order laboratory supplies and reagents. 👨‍🏫 Training and Development Train and mentor new and existing lab personnel. Stay current on advancements in PCR technologies and protocols. Promote a culture of continuous learning and professional development. 🎓 Qualifications & Skills: Bachelor’s or master’s degree in molecular biology, Genetics, or a related field. Proven experience in PCR lab operations and team leadership. Strong skills in PCR assay development, optimization, and troubleshooting. Proficiency with lab information management systems (LIMS) and data analysis tools. Excellent communication, organizational, and problem-solving skills. Ability to thrive in a fast-paced, high-stakes environment. Willingness to travel on short notice and take on mid-term assignments if required. Strong team orientation and customer-focused mindset. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting –Enterprise Risk - ER – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

Domain SME / BA For Manufacturing For LS Job Summary: Senior Business Analyst with strong domain expertise in Life Sciences manufacturing. This hybrid role blends the analytical rigor of a BA with the strategic insight of a Subject Matter Expert (SME). You will collaborate with clients to analyze business needs, define compliant and scalable technology solutions, and bring industry best practices to digital transformation initiatives. Key Responsibilities Business Analysis & Solution Design: Elicit, analyze, and document business and functional requirements from Life Sciences manufacturing stakeholders. Translate client needs into actionable user stories, use cases, and process flows for development and solutioning teams. Collaborate with architects and delivery teams to design solutions aligned with manufacturing operations and regulatory standards. Domain Advisory Act as a trusted advisor to clients by providing insights into industry best practices across GMP, batch processing, MES, QA/QC, and shop floor integration. Guide clients in aligning technology solutions with compliance requirements (e.g., 21 CFR Part 11, GAMP 5, GMP). Contribute to validation strategies and regulatory readiness for digital systems. Client Engagement & Pre-Sales Support Participate in discovery workshops, assessments, and solution ideation sessions with prospective clients. Support proposal development with domain input, business case justifications, and solution outlines. Help craft roadmaps for digital transformation initiatives, particularly around MES, ERP, LIMS, or other manufacturing IT systems. Thought Leadership & Enablement Stay up-to-date with Life Sciences manufacturing trends and bring forward innovative ideas (e.g., digital twins, real-time release, AI in QA). Contribute to internal knowledge repositories and mentor junior BAs or team members on domain topics. Required Qualifications Bachelor degree in Life Sciences, Engineering, or a related field. 8+ years of experience as a Business Analyst, with 3+ years in the Life Sciences manufacturing domain. Deep understanding of manufacturing operations, systems (MES, ERP, LIMS), and regulatory frameworks. Strong communication and collaboration skills and the ability to work with both business and technical stakeholders. Proficiency in tools such as Visio, JIRA, Confluence, and data visualization/reporting platforms Show more Show less

Key Responsibilities: Manage user accounts, roles, and permissions within Revvity E-Notebook. Configure templates, workflows, and metadata fields to align with lab processes. Provide training and support to users; develop SOPs and user documentation. Ensure compliance with data integrity standards (e.g., ALCOA+, 21 CFR Part 11). Troubleshoot system issues and coordinate with IT and vendor support. Maintain documentation of system configurations, user logs, and change history. Support audits and inspections by providing system access logs and compliance reports. Technical Requirements: ELN Experience: Hands-on experience with Revvity E-Notebook or similar platforms (e.g., LabArchives, Benchling, IDBS). System Configuration: Ability to configure templates, workflows, and user roles. SQL & Oracle: Proficiency in writing SQL queries for data extraction, reporting, and troubleshooting; experience with Oracle databases for backend data management and integration. Data Management: Understanding of structured data entry, metadata tagging, and version control. Compliance Knowledge: Familiarity with GxP, 21 CFR Part 11, and audit trail requirements. Basic Scripting (Preferred): Exposure to scripting languages (e.g., Python, JavaScript) for automation or integration tasks. API Integration (Preferred): Understanding of REST APIs for connecting ELN with LIMS or other lab systems. IT Collaboration: Ability to work with IT teams on system upgrades, backups, and security protocols. Documentation Tools: Proficiency in Microsoft Office, SharePoint, and documentation platforms like Confluence or Notion. Soft Skills: Good communication and interpersonal skills. Ability to work independently and in cross-functional teams. Experience: 3 - 5 years of relevant industry experience. Show more Show less

Position Title: Executive – Quality Control Qualification And Experience M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job Overview Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India Show more Show less

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation Show more Show less

Context Sanofi strategic direction is to standardize processes across sites, to embrace the digital transformation of its Manufacturing & Supply perimeter, looking at the opportunity to simplify its current solution landscape and leverage advanced technologies to bring business value. In that context, the MARS program aims to implement the Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). The MARS (MES Accelerated Roadmap @ Sanofi) program will transform Sanofi plants, improving compliance, cost and cycle time performance. Over the last 3 years, Sanofi has deployed 30 Production sites across 4 GBUs (multiple and different pharmaceutical processes, 18 Weighing & Dispensing & 12 full MES), and a second wave, should start in the coming years (> 50 production sites, pending business case confirmation). This represents a strategic opportunity for an Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value for Manufacturing & Supply and deliver best-in-class solutions to our industrial sites, with a high focus on electronic batch record management (content, execution) & review by exception process; Deliver innovative "state of the art" tools enabling performance for manufacturing processes across the industrial affair sites; Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently About the job The Digital MES Deployment & Integration Expert ensures the optimal performance of MES systems and Platforms by delivering solutions tailored to business needs. This role plays a central part in the deployment and evolution of Sanofi’s MES Core Model across industrial sites. Main responsibilities: End to end responsibility to install, configure, and update Industrial sites MES Digital systems and Platforms. Provide high-level of support, coordination, and communication to Industrial sites projects, maintain documentation, and drive continuous improvement. Contribute to the evolution towards an innovative MES Standard by leveraging AI, Cloud services and DevOps tools. Optimize MES performance and monitoring through development and automation initiatives. Occasionally, it may be required to perform the installations / updates over the weekend depending on the industrial site requirements. Share knowledge and foster digital skills development within the MES domain. This cross-functional role involves close collaboration with industrial sites, digital teams, infrastructure, cybersecurity, and external partners. The expert stays up to date with internal standards, industry best practices, and emerging technologies, while also contributing to the optimization of digital maintenance processes and tools. MES Scope: MES Solutions Siemens MES Opcenter Execution Pharma Product Koerber MES PAS-X Product Technical landscape: Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# - Power-shell – VB – PL/SQL End-to-end pharmaceutical manufacturing process Production & Work Instruction Execution Traceability & Genealogy Weighing & Dispensing Integration with ERP, SCADA, LIMS, WMS, Labeling, OEE, Data Platforms Recipe & Batch Management Quality Control & Compliance (GxP) Real-time Monitoring & Performance Tracking Automation & Digital Maintenance Support About you Experience : 5+ years of experience in the Digital Manufacturing Execution System (MES) domain within the pharmaceutical industry, with a strong interest in upskilling on emerging technologies and enhancing MES technical capabilities and Industrialization, or 5+ years of experience with Cloud technologies and DevOps tools, driving automation, scalability, and system reliability/Industrialization, with a strong interest in upskilling in the functional MES domain. Soft skills : Strong focus on value delivery, with the ability to work autonomously on solution design and take ownership and leadership within the assigned scope. Proven ability to work effectively in large-scale multicultural, multilingual, and matrixed organizational environments. Solid understanding of manufacturing processes in pharmaceutical plants, with strong knowledge of GxP regulations. Agile methodology practitioner Knowledge of reporting tools (Power BI) MES Solutions Technical skills : Siemens MES Opcenter Execution Pharma MES Product Koerber MES PAS-X MES Product Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# - Power-shell – VB – PL/SQL Education : Engineering or Masters in Computer Science or related field (or equivalent experience) Languages : English Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Description: To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site Essential Functions: To be responsible for Analysis and Calibrations of Quality Control Laboratory instruments. To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions. To be responsible for Maintaining of Good Laboratory Practices in lab. To be responsible for Checking regular cleanliness of laboratory. To be responsible for Management of all types of Standards. To be responsible for Receiving and maintenance of Chromatographic columns. To be responsible for Cleaning of Instruments. To be responsible for Receiving samples and In-warding them in the respective registers/LIMS. To be responsible for Preparation and execution of Protocols. To be responsible for Maintain the contact with vendor. To be responsible for Daily temperature monitoring of QC laboratory Additional Responsibilities: To be responsible for Investigation related to LIR, deviations, OOS and OOT. To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's. To be responsible for Handling of Caliber e-LIMS Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance. Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 7 Year in QC department of sterilemanufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 yearswithin existing role.

Analysis related to qualification of Instrument/Equipment and Standards Qualification of Standards and Instruments Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 7 Year in QC department of sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.

Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India

Purpose As a Technical Consultant (TC) working with the implementation team, you will deliver implementation and/or consulting to projects to achieve successful on-time projects with client satisfaction. As an integral part of this team, you will be primarily responsible for developing C#, PL/SQL code, and Telerik reports to support these client projects. Essential Functions Develop custom code using PL/SQL to query and execute functions within the Clinisys Laboratory Solutions (CLS) LIMS platform, typically working from details provided by team members or working directly with the clients. Configure reports using Telerik Report Writer to be generated from within the Clinisys Laboratory Solutions (CLS) LIMS platform, typically working from details provided by team members working directly with the clients. Perform all alpha testing on the work you develop to ensure it meets all specified requirements and works properly when executed from within the CLS platform. Demonstrate completed work either to internal team members or directly to the clients as needed. Develop a strong understanding of the CLS functionality and its data model. Provide guidance to internal team members as to how to best accomplish specific project goals within that platform. Provide input to process improvements by monitoring both client and departmental feedback. Maintain a high level of commitment to superior customer satisfaction through the entire duration of the customer relationship. Resolve project issues in a timely manner or determine when escalation to senior staff or management is required. Collaborate with and mentors other Technical Consultants and Professional Services Consultants to expand own and others depth & breadth of Clinisys product knowledge. Effectively organize and prioritize project tasks to ensure timely completion of projects assigned. Complete other tasks as assigned. Skills needed to be successful Ability to work independently and effectively manage project priorities from start to finish Strong understanding of client/ laboratory workflow concepts relative to software applications with strong knowledge of interfaces Strong communication and presentation skills with the ability to present to all levels of the organization Strong analytical and problem-solving skills Able to provide mentoring and consultation to improve workflow processes and procedures. Required Experience & Education Bachelor’s degree in Computer Science, Software Engineering, Data Science, Bioinformatics, Healthcare, Chemistry/Biology, Life Sciences/Pharma, Forensics/Toxicology, or related field, or equivalent relevant work experience. 3+ years’ experience working with a LIS or LIMS system 3+ years’ experience with PL/SQL query writing (Oracle DB Knowledge preferred) 3+ years’ experience with C# programing 3+ years’ experience developing LIS/LIMS reports using a common report writing tool (i.e. Crystal Reports, SSRS, etc.) Shift Timings: This is a permanent role comprising a five-day week with shifts to cover our core UK hours from Monday to Friday. For India these are UK shifts from 1:30 PM to 9:30 PM IST. Preferred Experience & Education 3+ years’ experience developing reports using Telerik report designer 3+ years’ experience with Horizon LIMS, especially as a LIMS administrator 3-5 years’ experience working in a LIMS/LIS implementation environment 3+ years’ experience with API/Interfaces (HL7) Physical Requirements Work is performed in a normal office setting with minimal exposure to health or safety hazards. Prolonged periods of sitting at a desk and working on a computer. Up to 25% travel may be required. Moderate lifting/carrying 15-44 lbs; use of fingers, walking/standing 2-6 hours Exposure to hazardous materials or various weather conditions Travel to client sites that can pose risk associated with healthcare organization May be required to follow customer location health and safety requirements

Summary Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility. Support manufacturing sites with QC and related activities. About The Role Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities. Validate spreadsheets Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs) Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc Trend and report all QMS elements as per the request Monitor, trend and report Health Safety and Environmental parameters Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Perform activities of a Quality Control expert as defined by the respective sites Support regulatory requirements – routine queries, Chromatogram requests Compile Quality performance management decks Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed Essential Requirements Pharmacy/ Science/ equivalent from a reputed institute Min 3 years of experience in Quality Control / Analytical R&D / Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices GxP knowledge, Basic IT knowledge Good communication, presentation and interpersonal skills Experience of working closely with the global stakeholders Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

What’s The Role Shell's Environmental Reporting System (SERS) needs replacement to ensure regulatory compliance. The new program, "Environmental Insights," will report environmental metrics like GHG emissions, waste, water, and biodiversity. It's a top priority for Shell, receiving high-level visibility. The program aims to deliver a streamlined, integrated reporting solution, enhancing transparency and insights into environmental targets and regulatory commitments. It supports Shell's Powering Progress strategy and will implement Sphera Environmental Accounting and Compliance Assurance modules to improve reporting processes and data accuracy. As a Technical Specialist – Environment Insights is responsible for taking a lead role in coordinating and developing regulatory reports and applications for project operations, ensuring compliance with environmental regulations and legislation. Update environmental management plans, provide analytical support for GHG energy management systems, and troubleshoot issues for accurate emission reporting. Support audits, environmental monitoring programs, and provide daily technological support. Identify improvement opportunities using data analysis and best available technologies. Manage operational issues, support the net-zero emissions journey, and lead benchmarking activities. Ensure quality of operations reporting, increase collaboration, and champion continuous improvement initiatives. What You’ll Be Doing Responsible for taking a lead role in the coordination and development of regulatory reports and applications required for Project operations including regulatory requirements stipulated by the Commercial Lease, Project Certificate, water licenses and other regulatory instruments, legislation and approvals. Responsible for developing a proficient understanding of applicable environmental regulations and legislation and communicating implications on Project operations to management. Update Project Environmental Management and Monitoring Plans to reflect Projection operations and procedures. Provide analytical support in activities pertaining to GHG energy management systems (PI, EC, LIMS, EEST, CEMIS) and troubleshooting issues to ensure accurate emission measurement and reporting in SERS, Planning Systems and GCAT. Support and coordinate audits and verification of environmental data. Support the coordination of environmental monitoring programs and initiatives in tandem with site environment teams. Day to day technological support to operations (monitoring, guidance, optimization, trouble shooting, product quality assurance) Developing opportunities for improvement in key areas, including pro-active identification of abatement opportunities using Data Analysis including economic modelling, Best Available Technologies (aligned with asset improvement plans, external commitments, regulatory reporting and legal compliance). Manage and follow-up on operational issues, performance metrics, and determine root cause of the problems and implement sustainable corrective action. Support the net-zero emissions journey for the asset including bringing operational learning to different performance management and business planning processes. Support internal and external benchmarking activities (including data collection, analysis and reporting) and lead the effort to improve the existing systems and ways of working. Ensure Quality of Operations Reporting and Data Integrity. Track the quality of deliverables within the agreed cost and timeline and resolve if any quality issues / complaints raised by stakeholders in a satisfactory & timely manner Increase collaboration within TAO and with other processes Champion in Continuous Improvement (CI) implementation and ensure delivery of benefits. What You Bring Masters of Science/M.tech in Chemical Engineering/Process Engineering/ Environmental Engineering, or Bachelor’s Degree in Carbon Management. 5+ years of experience in an LNG, upstream, petrochemical or refining facility with experience in GHG management. Advanced knowledge of air quality calculation methodologies Advanced knowledge of equipment and emission sources within oil and gas Advanced knowledge of existing and emerging global air / water regulatory reporting requirements Enhanced data skills (e.g. working with large environmental data sets and calculation tracing) Business analyst skills (requirements collection/documentation, process mapping, analytical thinking, etc.) Awareness of digital system architecture planning (data flows) Serves as team resource in monitoring GHG accounting protocols, protocol changes, and interpretations of GHG accounting rules Leading and executing proper and timely preparation of emissions data to support all sustainability reporting (inclusive of CDP reporting), including preparation of accurate and efficient quarterly emissions data reports Ensuring that all emissions accounting processes are effective, efficient, and properly controlled Optimizing internal procedures that ensure alignment to external standards and guidelines Working with verification/assurance providers on annual emissions verification for reporting, Supporting external audit, verification and compliance requirements for all legal emissions accounting and reporting Identifying, obtaining, and maintaining credentials as the sustainability industry evolves and to meet asset and company needs Leading training of Energy Transition staff on process and standards to ensuring compliance on evolving standards and guidelines Driving simplification and digitization of reporting, where applicable; reducing cycle times, re-works, and manual activities, while instigating controls; and supporting business initiatives and cross-functional projects Works with project teams in developing GHG inventories and forecasts as well as techno-economic analyses of mitigation strategies for a range of local government and private sector clients. Works with project teams to develop qualitative decision support tools that evaluate climate action strategies through multiple lenses, including potential for mitigation, adaptation, resiliency, equity, and green economy benefits Ability to effectively lead a team of multi-disciplinary highly skilled staff. Goal oriented with a high degree of achievement drive and initiative and ability to get things done. High analytical ability combined with pragmatic approach to solving problems. Service oriented and customer focused. Influences policy formation on contribution of specialization to business objectives. Influences at level of division internally and influences customer/suppliers and industry at senior management level. Decisions impact work of employing organizations, achievement of organizational objectives and financial performance. Develops high-level relationships with customer’s suppliers and industry leaders. What We Offer You bring your skills and experience to Shell and in return you work with talented, committed people on one of the most important challenges facing our planet. You’ll have the opportunity to develop the skills you need to grow in an environment where we value honesty, integrity, and respect for one another. You’ll be able to balance your priorities as you become the best version of yourself. Progress as a person as we work on the energy transition together. Continuously grow the transferable skills you need to get ahead. Work at the forefront of technology, trends, and practices. Collaborate with experienced colleagues with unique expertise. Achieve your balance in a values-led culture that encourages you to be the best version of yourself. Join an organisation working to become one of the most diverse and inclusive in the world. We strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation, and life experiences to apply. Grow as you progress through diverse career opportunities in national and international teams. Gain access to a wide range of training and development programmes. Show more Show less