480 Lims Jobs - Page 20

Key Responsibilities:Quality Control (QC): ✅ Conduct analysis of raw materials, in-process samples, and finished products using approved test methods. ✅ Operate laboratory instruments (e.g., HPLC, UV spectrophotometer, FTIR) as per SOPs. ✅ Ensure proper sampling, labeling, and storage of materials and retain samples. ✅ Maintain calibration and qualification records of lab instruments. ✅ Conduct stability studies and maintain related data. ✅ Review and approve test results; report deviations or non-conformances. ✅ Manage laboratory reagents, reference standards, and consumables. Quality Assurance (QA): ✅ Review and approve batch manufacturing and packing records (BMR/BPR). ✅ Oversee compliance with GMP, SOPs, and regulatory requirements. ✅ Coordinate and participate in internal audits, vendor audits, and regulatory inspections. ✅ Handle deviations, change controls, CAPA (Corrective & Preventive Actions), and complaint investigations. ✅ Manage document control: issuance, review, and archiving of SOPs, policies, and records. ✅ Conduct training for plant personnel on quality systems and GMP. ✅ Perform periodic review and qualification of equipment, processes, and cleaning validation. Required Qualifications: Education: B.Sc. / M.Sc. in Chemistry, Microbiology, Biotechnology, or B.Pharm / M.Pharm Experience: 2–5 years in QC/QA within the pharmaceutical or nutraceutical industry Key Skills and Competencies: Strong knowledge of nutraceutical regulations (FSSAI, WHO-GMP, USFDA, etc.) Hands-on experience with analytical techniques and equipment Excellent understanding of documentation practices and quality systems Good communication and interpersonal skills Attention to detail, problem-solving ability, and proactive approach Familiarity with software like LIMS, ERP, or electronic documentation systems (if applicable) Performance Metrics: Compliance rate with regulatory and internal standards Accuracy and timeliness of testing and documentation Number of deviations, CAPAs, and their timely closure Successful audit outcomes (internal and external) Training compliance of plant personnel Job Type: Full-time Pay: ₹15,000.00 - ₹30,000.00 per month Benefits: Paid sick time Schedule: Day shift Supplemental Pay: Yearly bonus Work Location: In person

Job Description: Digital Transformation Lead digital and automation projects to enhance cost, productivity, and quality in manufacturing. Oversee project management from design to Go Live and ensure scalability and sustainability. Develop requirement documents and ROI calculations. Validation & Compliance Perform system validations ensuring compliance with cGMP, FDA, and GAMP standards. Maintain audit-ready documentation and adherence to the Validation Master Plan. Integration & Automation Collaborate with Engineering and IT for seamless system integrations (PLC, SCADA, IoT, LIMS, MES, ERP). Manage advanced manufacturing technology projects. Advanced Analytics Drive predictive analytics and real-time data projects to improve operational efficiency. Support energy-efficient and sustainable automation initiatives. Cybersecurity & Data Integrity Ensure compliance with cybersecurity policies and protect systems from threats. Collaborate with IT for security assessments and maintain data integrity. Cross-functional Collaboration Work with stakeholders across QA, IT, Operations, EHS, and Engineering to ensure project success. Provide training and support to teams on digital systems and automation. Continuous Improvement Stay updated on digital trends and Industry 4.0 solutions. Evaluate and recommend digital innovations to maintain a competitive edge. Team Capability Building Train staff on automation and digital systems, developing materials and conducting workshops. Education: BTech. B.Tech/BE (Preferred Stream - Computer Science, Electronics, Electronics & Communication, Instrumentation & Control Engineering, Information Technology) Electrical and Electronics will be preferred. Total Experience - 0-1 Year in sterile manufacturing plant

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

What you will do In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality work from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 4 to 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelors degree and 6 to 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Must-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS/ELN platforms such as Benchling, Revvity, IDBS, STARLIMS, Watson, LabVantage, etc. Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business collaborators Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills.

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.