Roles and Responsibilities Conduct quality control tests on raw materials, intermediates, and finished products using techniques such as HPLC, GC, FP, IP, Stability studies. Ensure compliance with cGMP guidelines and maintain accurate records of testing results. Investigate market complaints and perform microbiological analysis to identify root causes. Develop and implement quality assurance procedures for OSD formulations. Collaborate with cross-functional teams to resolve issues related to dissolution testing.

This role is part of ADS’s Global Technical Organization (GTO). GTO delivers world-class analytics and digital solutions on Ecolab’s Product Quality, Process Safety & Sustainability landscape. The team is responsible to maintain the highest quality standards by tracking performance metrics, identifying quality issues, and driving continuous improvement. Are you a driven individual with a passion for data and analytics? We're looking to hire an Analyst (GTO) to join our Global Supply Chain Analytics team in Pune, India. In this role, you’ll be responsible for leading initiatives in Digital Twin, Enterprise Quality KPIs, and to provide support in functional product deployments and maintenance. You’ll work closely with the quality functional stakeholders, data engineering and design teams to co-create quality products and solutions to get them design reviewed before of formal product launch. You’ll also serve to bring functional thought leadership and industry best practices for experimentations and deployments. What You'll Do Data Collection & Integration Gather and integrate data from manufacturing systems, supply chain platforms, and IoT devices using OSI PI. Ensure real-time data availability, reliability, and accuracy to support operational needs Configure and maintain data points, historians, and visualization tools. Data Analysis And Visualization Utilize Seeq for advanced data analytics and trend analysis to identify patterns and root causes of inefficiencies as well as analysis on various quality indicators. Create dashboards, reports, and KPIs using PowerBi, Redzone to provide actionable insights to stakeholders. Work closely with process engineers/plant managers to identify and manage process bottlenecks and drive operational efficiency. Product Development and Deployment Work on various plant-level process efficiency improvement, automation and controls and Digital Twin projects like Aveva, Redzone among others. Leverage product quality methodologies like Capable / non-capable specs, spec deviations, supplier quality audits and assessments for overall Quality KPIs, root cause analysis (RCA), CAPA and Supplier Corrective Actions (SCAR). Functional Knowledge Management Contribute to knowledge management and continuous improvement initiatives. Partner with cross-functional teams to ensure successful project delivery. Stay updated on the latest developments in supply chain technologies and provide recommendations for system upgrades or integrations Act as a subject matter expert on OSI PI, Seeq, and Redzone, providing training and support as needed. What You Bring Bachelor's degree in chemical, mechanical engineering, computer science, information systems, or a related field (advanced degree a plus). 2+ years of experience in quality foundations and philosophies like 8D, problem solving, statistical process control (SPC), RCA, process capability, value stream mapping and six sigma principles. Good to have – six sigma green belt certification, data historians like OSI PI, & real-time analytics tools like Seeq, Redzone. Knowledge of Digital Twins, LIMS Understanding of Manufacturing Key Performance Indicators. Excellent analytical and quality problem-solving skills with a keen eye for detail. Entry-level exposure to technical skills in visualization using MS Power BI and familiarity with programming skills in Python and M language Good to have exposure in cloud platforms (Azure / AWS) and data management in SQL querying and SAP tables/transactions, Snowflake Strong communication and collaboration skills. Ability to thrive in a fast-paced environment and manage multiple projects. What’s In It For You Opportunity to join a growth company offering competitive compensation and benefits. The ability to make an impact and shape your career with a company passionate about grooming talent for creating future leaders. The support of an organization that believes it is vital to include and engage diverse people, perspectives, and ideas to achieve our best. Feel proud daily to work for a company that provides clean water, safe food, abundant energy and healthy environments. Our Commitment to Diversity and Inclusion Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability. Show more Show less

Summary Biomedical Research (BR) is the global pharmaceutical research organization of Novartis. With approximately 6,000 scientists and physicians around the world, our research is focused on discovering innovative new drugs that will change the practice of medicine. We have an open and entrepreneurial culture, encouraging collaboration to make effective therapies. At BR, our mission is to discover innovative medicines that treat disease and human health. To do that, our scientists need cutting-edge, state-of-the-art computing systems. With Research Informatics (RX), BR is making a strategic investment into informatics capabilities and is positioning itself to deliver the systems and services that are critical to the future of drug discovery. Purpose Of The Role Novartis’ Biomedical Research (BR) Informatics (RX) group is establishing a strong presence in India, and we are seeking proactive and versatile professional in the role of Software Product Operations Manager for supporting Pre-Clinical and Clinical systems . As an IT Product Operations Manager (POM) you will co-lead and manage, together with a Product Manager and a Tech Lead, complex, globally deployed, high-impact software solution. you are accountable for all aspects of the software operations from providing operational perspective to product roadmaps, user-support & communication, planning & communicating operational maintenance cycles, maintaining stable & secure systems, increasing the value and operational excellence of the product. About The Role Key Responsibilities: Responsibilities As a co-lead and a member of a cross-functional, matrixed team, consisting of software and data engineers, business analysts, designers and supporters, your primary responsibilities will include: Owning all aspects of operations for one or more software applications within our product team, including stable operations and infrastructure Mitigating operational risks and manage incident detection and resolution Manage incidents, problem and change management and troubleshooting, Providing end-user support, communication, knowledge-base documentation, and trainings Leading vulnerability management efforts, ensuring security, compliance, usability, performance, and sustainability requirements are met Ensuring license compliance, applying application patches, and managing roll-out of upgrades Guiding and coordinating small teams of external application supporters, ensuring effective prioritization of operational activities delivery, Monitoring key system performance metrics and facilitating operational excellence of the product Ensuring adherence to Novartis global Information Security and Quality standards and policies for all products/services. Ensuring compliance with company standards & policies (e.g., Good Laboratory Practice (GLP) & Good Clinical Practice (GCP)) Ensuring operational activities and outcomes are reflected on product roadmaps Engaging with other product teams within and across product lines to leverage operational synergies Working experience Essential Requirements Experience in scientific application support and maintenance in pharmaceutical industry Experience in a drug discovery, scientific research, pre-clinical or Clinical setting preferred Prosses broader knowledge of basic IT architecture on Windows, Linux OS, web service, network etc Good troubleshooting skills and customer focused. Good working knowledge of application deployments Working experience with LIMS and sample management system Working experience with database, Oracle and MSSQL, SQL and PL/SQL Good understand of support model with incident, problem and change management Familiarity with Agile software development and SDLC and ITIL Awareness of authentication protocols Knowledge of cloud environment and services (AWS - Amazon Web Services, Azure, SaaS) Knowledge of AI principles Good understanding of CSV (Helpful to have a GxP understanding). Highly collaborative, proven experience as a team player Strong communication skills Education And Qualification Requirements 7+ years relevant subject matter expertise, obtained through experience or education in software support or operations in a complex environment Bachelor's degree in a technology or scientific subject 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. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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

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

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

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

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

Company Description At ProvenTech, we are leaders in digital innovation, specializing in development, implementation, and support for the Life Sciences and Healthcare sectors, including pharmaceuticals, biotech, and nutrition. Our expertise lies in revolutionizing manufacturing processes with Industry 4.0 and Pharma 4.0 technologies, driving productivity and operational efficiency. We design and deliver secure, scalable, and stable systems tailored to unique business needs, providing end-to-end solution architecture for sustainable growth. Our customer-centric approach, combined with cost-effective solutions and domain expertise, ensures that we deliver products aligning with clients' vision, empowering them to achieve success. Role Description We are seeking a highly motivated and detail-oriented individual to join our team as a LIMS Master Data Creation Specialist. In this role, you will be responsible for the accurate and timely creation and maintenance of master data within our LIMS platform. The successful candidate will possess a strong understanding of laboratory workflows and data management principles, along with excellent organizational skills and the ability to work independently and collaboratively within a team environment. Key Responsibilities: Utilize knowledge of laboratory processes and terminology to accurately translate requirements into LIMS master data configurations. Collaborate with laboratory staff and project stakeholders to gather requirements for master data creation and ensure alignment with business needs. Configure LIMS system settings, including sample types, test methods, analytical procedures, and other relevant parameters. Input and validate data in accordance with established Procedures and quality standards. Perform routine data maintenance tasks, including updates, corrections, and archival of obsolete data. Troubleshoot Master data-related issues and provide timely resolution to ensure system integrity and reliability. Document master data creation processes, standard operating procedures (SOPs), and system configurations. Provide training and support to end-users on master data management best practices and system usage. Collaborate with cross-functional teams, including IT, quality assurance, and laboratory operations, to support system integration and enhancement initiatives. Stay informed about industry trends and emerging technologies related to laboratory informatics and master data management. Show more Show less

SAP Master Data Expert - 6 months - Contract - Full time - Remote with AdHoc Travel We are seeking a meticulous and collaborative SAP Master Data Expert with functional business experience in SCM and MM to support enterprise-wide data transformation initiatives within the pharmaceutical sector. This role plays a critical part in ensuring the integrity, compliance, and readiness of master data—particularly in regulated domains such as manufacturing, quality, regulatory, and clinical systems. You will work closely with IT, regulatory affairs, quality assurance, and business stakeholders to ensure seamless data migration from legacy systems to validated platforms. Key Responsibilities Data Preparation & Governance Collaborate with IT and country-level Business Data Owners to identify in-scope data objects, including product, material, batch, and regulatory data. Maintain and govern master data lists for assigned objects, ensuring alignment with GxP and data integrity standards. Support the development of value mappings and data transformation rules in collaboration with technical teams. Provide domain-specific business insights to guide data extraction and conversion from legacy systems. Data Quality & Compliance Execute data cleansing activities in accordance with project timelines and regulatory expectations (e.g., ALCOA+ principles). Validate data quality throughout the migration lifecycle, ensuring compliance with internal SOPs and external regulatory requirements (e.g., FDA, EMA). Approve and execute data verification scripts to ensure completeness, consistency, and traceability. Data Migration & System Readiness Collect and prepare data for manual or construction-related objects, including those in manufacturing execution systems (MES), LIMS, or ERP platforms. Approve upload files pre- and post-load, ensuring formal documentation and audit readiness. Perform manual data entry and dual maintenance where required, particularly in validated systems. Hypercare & Issue Resolution Act as the Single Point of Contact (SPoC) for assigned data objects during Hypercare, supporting issue triage and resolution. Collaborate with QA and IT to manage data-related defects and ensure timely remediation in line with change control procedures. Key Performance Indicators (KPIs) Regulatory-Grade Data Cleansing : Completion of data cleansing activities in accordance with project timelines and compliance standards. Validated Data Loads : Successful and audit-ready data loads into GxP systems, aligned with migration schedules. Issue Resolution Efficiency : Timely resolution of data quality issues, with full documentation and traceability. Qualifications Experience in data migration or master data management within the pharmaceutical or life sciences industry. Expertise in Supply Chain Management(SCM) and Material Management/Master Modules(MM) within SAP in a Functional or Hands off capacity Familiarity with GxP, ALCOA+ principles, and regulatory data standards (e.g., IDMP, SPOR, ISO IDMP). Proficiency with data tools and validated systems (e.g., SAP, Veeva Vault, LIMS, TrackWise). Strong analytical, documentation, and stakeholder communication skills. Understanding of data governance frameworks and regulatory compliance requirements. If you feel this role is a good fit for you - Contact me on sozay@redglobal.com or Apply within! Show more Show less

Job Description Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instrument's / equipment's . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instrument's / equipment's. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity. Qualifications Qaulification # B.Sc./M.Sc. Experiance # 1-3 Years Desigantion # As per company Policy About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. 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: 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

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: 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

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: 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

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Data Scientist II, BIA GPS India Operations Summary The Data Scientist II will play a crucial role in supporting operational analytics across GPS to ensure products continue to serve most pressing GPS analytics needs, with potential opportunities to build new advanced analytics capabilities such as predictive modelling, simulation, and optimization. The Data Scientist II should have a strong interest in solving business problems, and an eagerness to work on all parts of the analytics value chain, from partnering with IT on data pipelines to operationalizing analytics in the service of our patients around the world. Roles & Responsibilities Conduct analysis and interpretation of complex data sets to derive meaningful insights and recommendations based on an understanding of GPS priorities, critical issues, and value levers. Collaborate with stakeholders to identify business problems, goals, and KPIs to to design, establish and maintain data pipelines, models and business facing reports and dashboards. Design, develop, and implement a broad array of GPS analytics that solve complex problems in a computationally efficient and statistically valid manner. Identify and implement enhancement and automation of high-value analytics while ensuring they continue to function efficiently. Collaborate proactively with IT teams to develop and enhance data infrastructure, data pipelines, and analytical tools for efficient data collection, processing, and analysis. Prepare reports, dashboards, and presentations to communicate analyses to stakeholders at various levels of the organization. Follow technical best practices in building, maintaining, and enhancing analytics output with scalable solutions, including code version control, pipeline management, deployment, and documentation. Provide training, guidance, and mentorship to junior analysts and team members when required. Work hours that provide sufficient overlap with standard east coast US working hours. Skills and competencies Strong analytical thinking and problem-solving skills with the ability to analyse complex data sets and draw meaningful conclusions. Agile problem-solving ability and desire to learn new things and continuously improve. Proficiency in statistical analysis techniques and methodologies. Strong project management skills and the ability to work independently or as part of a team. Solid understanding of digital analytics tools and platforms and version control. Strong communication skills with the ability to present complex information to non-technical stakeholders in a clear manner. Strong business acumen and strategic thinking, with the ability to translate analytical findings into actionable insights and recommendations. Experience Bachelor's or Master's degree in an analytical, engineering, operations research or scientific discipline. Proven experience (typically 3-5 years) in a data and analytics role, including direct development experience. Experience working with large datasets, data visualization tools, statistical software packages and platforms (specifically R, Python, advanced SQL, Domino, AWS, GitHub, dbt, Tableau) Experience with major GPS applications (SAP, Oracle, LIMS, Infinity, MES) is a plus. Experience with biotech product development, manufacturing operations, supply chain, and quality control is a significant plus. Experience in the biopharma industry a plus. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

Job description Job Title: Siemens Opcenter Pharma Execution MES Specialist Location: Chennai or Pune (Hybrid) Notice: Immediate Joiners( 0- 30 days only consider ) Job Type: Full-Time We are seeking a skilled MES Specialist with hands-on experience in Siemens Opcenter Execution Pharma to support digital transformation in pharmaceutical manufacturing. The ideal candidate will help implement, configure, and optimize MES solutions to ensure compliance, efficiency, and data integrity. Responsibilities: Configure and deploy Siemens Opcenter Pharma MES solutions. Design and implement Electronic Batch Records (EBRs). Integrate MES with ERP, LIMS, and automation systems. Support system validation in compliance with GMP and 21 CFR Part 11. Troubleshoot MES issues and provide user support. Requirements: Proven experience with Siemens Opcenter Pharma MES. Strong understanding of pharmaceutical manufacturing processes. Familiarity with GMP regulations and GAMP 5. Experience with MES-ERP integration (e.g., SAP). Excellent problem-solving and communication skills. Show more Show less

Position Overview: We are seeking a dedicated and experienced Quality Control Analyst to join our pharmaceutical team. The ideal candidate will be responsible for ensuring the highest quality standards in our analytical processes, documentation, and laboratory operations. Key Responsibilities: Analyst Qualification & Training: Oversee the qualification process for analysts. Conduct and coordinate training programs for QC employees to ensure compliance with current standards and practices. Documentation Management: Prepare and review critical documents, including Specifications, Standard Testing Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Transfer Protocols (MTP), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR). Analytical Data Review: Review analytical data for routine samples, including in-process samples, Drug Substance (DS), Drug Product (DP) release, and stability samples. Oversee method transfer and method validation processes. Reference Standards & Material Management: Manage reference standards and oversee the indenting process for materials required in QC. Calibration Coordination: Coordinate with external vendors for instrument calibration. Collaborate with QC personnel for in-house calibration and verification of laboratory instruments. Laboratory Equipment Maintenance: Ensure proper maintenance and management of laboratory equipment and instruments to guarantee optimal performance. Method Validation & Transfer: Manage activities related to method validation and method transfer to ensure accurate and reliable analytical results. Quality Incident Management: Initiate and investigate incidents, deviations, change controls, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA), and Out of Trend (OOT) findings. Analysis Planning: Plan and schedule analyses for Drug Substance (DS), Drug Product (DP), stability studies, and protocol-based samples. Technical Expertise: Proficient in handling High-Performance Liquid Chromatography (HPLC) instruments, including Reverse Phase HPLC (RP-HPLC). Experience with Laboratory Information Management Systems (LIMS). Skilled in using chromatography data systems such as Chromeleon and Empower 3. Familiarity with Cation Exchange Chromatography (CEX) techniques. Qualifications: Master’s degree in Chemistry or a relevant field. Minimum of [Insert Number] years of experience in a pharmaceutical quality control laboratory. Strong understanding of cGMP, GLP, and regulatory requirements. Excellent analytical and problem-solving skills. Effective communication and teamwork abilities. Show more Show less

Job Description JOB DESCRIPTION Analysis and release of RM, PM, IP and FP Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KF titrator. Knowledge of Chemical analysis. Knowledge of LIMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Knowledge of QMS Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department. Qualifications Education: B.Sc., M.Sc., B.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. Show more Show less

Job Description 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 KF titrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Testing of Miscellaneous Material, in-process, finished product and stability samples (as per stability protocol) To ensure the timeline for initiation and completion of testing. To keep update of instruments logbooks and to record the data in LNB during testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department Qualifications 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. Show more Show less

Job Accountabilities Support shift in charge for shift co-ordination work. Priorities the samples for testing. Provide right containers to collect samples, identifies right carriers to distribute samples and designate right location for pre-testing storage. Ensure the usability of the chemicals / standards to use in the test and performs the test by following the procedure step by step. Confirms test results by using validation techniques before reporting. Calibration - Identify the calibrations as per the method protocol and the instruments as per schedule. Prepare calibration and working standards as per requirement. Perform the calibrations as per the method and instrument as per schedule. Standardizes the laboratory solutions. Evaluates performance of additives and process chemicals. Collects samples of raw materials as per the requirement and track the quality of incoming raw material. Timely testing and results reporting of Raw materials, in process, product & trouble shooting samples of all plants. Classify the product grades based on the specification. Detect exceptions or deviations in test results Perform on-spot mitigation in emergency situation under the guidance of the section head Ensure proper sample retention as per defined lab procedure for addressing issues with customers (need based) Dispose left over samples safely as per SOP and co-ordinate with plant and other agencies for further actions. Awareness about Laboratory Quality Systems requirements and good knowledge and skills for LIMS and SAP QM operations for day to day laboratory work. Maintain laboratory inventory (Reagents, Glassware, and Equipment) and raise the requirement for its availability in time. Participate in various audits of lab quality systems including safety. Data Management Comply to quality systems Ensure timely entry approval of test results in LIMS. HSE & other regulatory compliance Stay aware of environmental, site, statutory regulations. Handle chemicals and tools as per safety norms Ensure Good Housekeeping and safe working conditions Follow and enforce applicable HSE procedures/ practices Learning & mentoring Conduct on job training to analysts and new joiners for laboratory analytical work. Business / Function-specific Competencies (Technical /Functional) Participate in external trainings and events as advised by the section head Timely execution of assigned tasks Erratic changes in plans Working with multiple interface such as business, customers, operations, E&M and HSEF Sample management Prioritization of assigned activities HSEF -specific Competencies Fire Safety Management Fire & Gas Detection system Waste Management Integrated Management System RIL HSE Management System HSE Policy, Principles, Standards and Procedures & Practices Emergency Preparedness and response Skills Statistical Skill required assessing the reliability of test results. Relevant knowledge of the test procedure and results reporting as per standard method requirement. Knowledge of Raw Material, in process samples & finished product specifications and analysis as per contractual & domestic specifications. Competency to operate specific equipment, perform test, calibrations and evaluate results. Knowledge of significance of test parameters including safety in laboratory. Education & Experience : B. Sc. Chemistry, Masters preferred. Minimum 4-9 years in QA/QC discipline Show more Show less

Summary The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures. eCompliance Manager provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects. About The Role Location – Hyderabad Key Responsibilities Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. Review and approve the GxP Changes and the associated deliverables. Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented. Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. Perform supplier qualification assessment activities. Provide Audit support as assigned and in case of CAPAs, provide the required Quality support. Essential Requirements xP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements. On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems. Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues. Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported. Client/stakeholder satisfaction and corresponding feedback. Desirable Requirements 10-15 years of overall IT experience, and a minimum 7 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.) Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments Experience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.) Successful cross-divisional/functional work with complex international teams Experience in GxP supplier qualification activities Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Ability to effectively interact and present to Management Ability to manage the key stakeholders and build trust Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, negotiation, facilitation, and interpersonal skills 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. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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

LabWare Developer JD LabWare Developer with work experience of at least 4 years and responsibilities that include: Gathering user requirements to understand the needs of the laboratory and stakeholders. Configuring LabWare LIMS and providing technical assistance to the team and troubleshooting when needed. Configuration and creation of Master Data including but not limited to Products, Projects, Analysis, Calculations, Automation Scripts, Message Engine etc. Good knowledge of LIMS Basic – format calculations, analysis component calculations (variables properties, writing basic algorithms) Good Knowledge of Labware Lot Management and Sample life cycle Configuring and customizing LabWare LIMS to meet specific laboratory needs. Integrating instruments with LabWare LIMS to ensure seamless data flow and automation. Knowledge of Crystal reports and Creation of Reports utilizing Query Tags and Access Routines Performing entry and edit of all relevant static data within the system. Acting as a liaison between internal laboratory users and the vendor to address system issues and user requirements. Developing and maintaining custom scripts and automation scripts to implement / enhance system functionality. Working with Agile teams to implement new features and improvements. Troubleshooting and resolving system issues to ensure smooth operation. Collaborating with cross-functional teams to integrate LabWare with other systems and workflows. Ensuring compliance with industry standards and regulatory requirements in all system implementations. Supporting data migration and integration efforts to ensure data integrity and consistency. Monitoring system performance and optimizing configurations to improve efficiency and reliability. The ideal candidate for this role should have strong technical skills in LabWare LIMS, experience with scripting and automation, proficiency in using Crystal Reports, and excellent problem-solving and communication skills. Show more Show less

Job Summary We are seeking an experienced Full Stack Engineer with 10 to 12 years of experience to join our team. The ideal candidate will have a strong background in LIMS and a good understanding of Bioinformatics. This hybrid role requires a deep technical expertise and the ability to work collaboratively in a dynamic environment. The position does not require travel and operates during day shifts. Responsibilities Develop and maintain full stack applications with a focus on LIMS integration. Collaborate with cross-functional teams to design and implement new features. Ensure the scalability and performance of web applications. Provide technical guidance and mentorship to junior developers. Conduct code reviews and ensure adherence to best practices. Troubleshoot and resolve complex technical issues. Work closely with stakeholders to gather and refine requirements. Implement security best practices to protect sensitive data. Stay updated with the latest industry trends and technologies. Contribute to the continuous improvement of development processes. Document technical specifications and project plans. Participate in agile ceremonies and contribute to sprint planning. Ensure the quality and reliability of software through rigorous testing. Qualifications Possess a strong background in LIMS with hands-on experience. Have a good understanding of Bioinformatics and its applications. Demonstrate proficiency in both front-end and back-end technologies. Exhibit excellent problem-solving and analytical skills. Show strong communication and collaboration abilities. Have experience with agile development methodologies. Be familiar with security best practices in software development. Hold a degree in Computer Science or a related field. Have a proven track record of delivering high-quality software solutions. Be adaptable and open to learning new technologies. Demonstrate the ability to work independently and as part of a team. Show a commitment to continuous improvement and professional development. Have experience with cloud platforms and services. Certifications Required Certified LIMS Professional Full Stack Web Development Certification Show more Show less

Specialist, Manufacturing Execution System (MES) The Manufacturing Execution System (MES) Specialist acts as a subject matter expert for authoring and updating electronic master batch records. The primary responsibility is to ensure that the deployment of the Werum/Korber PAS-X electronic Master Batch Records are successfully and supported to maximize business benefits and are in line with site business process and technical standards. The MES Specialist will also be responsible for MES integrations – DCS, SAP, LIMS etc. Duties The specialist will be supporting MES trainings, collaboration, benefit realization, and standardization. The Specialist will follow the standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes. The MES Specialist is responsible for activities that include the following: Identifies and implements continuous process improvement opportunities. Sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Werum/Korber generic configuration. Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance. Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations. Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit. Required Experience And Skills Direct experience with MES (PAS-X) with nice to have experience in MBR, GMBR. Proven track record of analytical skills, problem solving and attention to detail. High personal integrity, credibility, and energy Excellent communication and influencing skills while working. Strong written and verbal communication skills. Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into Automation/Digital Solution. Preferred Experience And Skills Knowledge of SAP, MuleSoft interface. Knowledge of L2 Systems (Historian, SCADA, DCS) integration with PAS-X MES Responsibility Provide first and second-line support for MES – PAS-X applications. Troubleshoot and resolve application issues reported by users. Resolving Incident/ problems within SLA (response time/ resolution time) Monitor application performance and ensure efficient functionality. Communicate with users to understand and resolve issues promptly. Verbal and written communication with end users/ IT stake holders in process of finding resolution Document all support activities and solutions in the ticketing system. Escalate complex issues to third-line support or development teams. Collaborate with the development team to identify and resolve bugs. Estimating and implementing changes (proactive/ reactive) to permanently fix the incident or as a planned change Conduct routine checks and maintenance of the PAS-X applications. Ensure compliance with all regulations and standards. System validation as per Quality process and SoPs System/ application administration activity (periodic maintenance, process compliance e.g. GMP audit, security administration, capacity planning etc.) Available to work in rotational shifts including night, morning and weekend shift. Availability to work outside office hours when the need arises. Ability to prioritise the criticality of support issues as they arise and act accordingly. Able to pick up Cross-Trainings and willing to learn other OT applications. Write, review and update KBA Documents for the Support Team. Perform periodic monitoring and qualification testing on new / existing systems according site procedures. Show more Show less

Job Category: Quality Job Family: Plant Quality Assurance Job Description: To provide leadership to the men working in the QC department and be accountable for their performances. To assess and monitor performances of partners working in the department. What you’ll do: To organize shift duty for all employees & allotment in respective shift of the section. To give release for all products on the basis of specification and customer requirement through Oracle system. To ensure that all testing done by the subordinates are as per Standard Operating Procedures. To verify quality records on routine basis. To ensure coordination with production for product quality feedback. Review & circulate new product formulation & specification to concerned partners. To provide customer complaint response. To give in house training to subordinates as and when required. To implement & follow the GMP & GLP requirements. To carry out sensory evaluation of products. To prepare COA of finished product. To carryout cleaning validation, allergen validation and any process validation as and when required Co-ordinate with production in case of any deviation in product. To raise indents for glassware’s/chemical and other requirement for lab. To send samples to external lab and customer as per requirement. To comply with the requirements of Food safety Management Systems. To carry out any other job assigned by the seniors. To conduct Proficiency test of all analysts. To give conditional release prior to completion of inspection and testing in consultation with seniors / customers. Review HACCP plan & other ISO relevant document. Review action taken on non-confirming product & closure of NC. To participate in external audits. To conduct forward and backward traceability as per defined frequency and as & when required. Implementation of policies decided by the higher authorities. To comply with the requirements of EMS & OHSAS 18001. To set the safety goals and objective and ensure compliances with team support. To define, implement and maintain the compliances of safety rise initiative & inform team to comply the same. Set target of BBS, safety rise, JCC and safety audit score and track the outcome of the programs. Track, analysis and investigate the incidents. To review the HIRA & Aspect impact of section. Coordinate central safety committee and safety steering committee meeting Provide training to partners on OH&S management system. Log sheet verification RM / PM Challenges, Online Challenges Communication to relevant stakeholder To enter QPA data in system and circulate the reports to all concerned partners. Regular plant round & highlight deviations with concern team. Attend meetings & calls with internal & external team, Customers. Sensory / KQT of product as per requirement. Fulfill GLP requirements PDI observations share with team & follow up. Fulfill LIMS requirements What you need to succeed: Bachelor’s/ Master's Degree in Food Science, Dairy Technology, B.SC/ M. M.Sc. Chemistry, Microbiology or related field is required 10+ years’ experience in Quality Assurance, Food Safety or Production Candidate shall have a sound knowledge of Quality control of milk and milk products, juice & Beverages. Well versed with the Food safety principles, HACCP and Proven leadership experience in a team environment Excellent interpersonal and problem-solving abilities (relationship building, teamwork, interpersonal insight, conflict resolution, customer orientation) Excellent Communication Skill (verbal communication, persuasive impact, listening, written communication) Judgment and thinking (strategic thinking, original thinking, judgment and decision making, problem solving, awareness) Performance skills (accuracy with detail, planning and organizing, efficiency, business acumen) Personal Characteristics (motivation/commitment, flexibility, assertiveness, develop orientation result orientation resilience, quality orientation) Show more Show less