488 Lims Jobs - Page 18

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 Title: IT Project Manager – Pharmaceutical Systems & Compliance Location: Verna, Goa Experience Required: Minimum 5 years Job Type: Full-Time | Onsite Job Summary: We are seeking a skilled IT Project Manager to lead cross-functional IT projects within a regulated pharmaceutical environment . The ideal candidate will be responsible for planning, execution, and delivery of enterprise IT systems while ensuring compliance with regulatory standards such as GxP and 21 CFR Part 11 . This position requires experience in managing IT projects related to ERP, CRM, and LIMS systems within the pharmaceutical or life sciences industry. Key Responsibilities: Develop and manage detailed project plans, schedules, and resource allocation. Lead cross-functional teams across IT, business, QA, and external vendors. Ensure timely delivery of project milestones and adherence to project goals. Conduct regular project meetings and maintain transparent stakeholder communications. Identify and escalate project risks and issues as appropriate. Ensure compliance with GxP, 21 CFR Part 11, and other relevant standards. Oversee the implementation of pharma-related systems (ERP, CRM, LIMS). Collaborate with QA and regulatory teams for documentation and validation. Provide leadership, foster collaboration, and mentor project staff. Required Qualifications: At least 5 years of experience managing IT projects in the pharmaceutical or life sciences domain. Strong understanding of GxP , 21 CFR Part 11 , and related compliance frameworks. Experience with enterprise system implementations (ERP, CRM, LIMS). Proven ability to manage stakeholders, solve problems, and deliver results. Ability to handle multiple priorities in a regulated environment. Preferred Skills: PMP or equivalent project management certification Experience with system validation and pharma audits Strong vendor management and negotiation skills Perks & Benefits: Long-term opportunity in a growing industry Leadership exposure and cross-functional collaboration Work in a compliance-driven and quality-focused environment How to Apply: Submit your updated resume highlighting your relevant experience in pharmaceutical IT project management. Job Types: Full-time, Permanent Pay: ₹30,000.00 - ₹45,000.00 per month Schedule: Rotational shift Work Location: In person Speak with the employer +91 8590922750

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.

Roles and Responsibilities Conduct quality control testing of OSD products using HPLC, GC, and other relevant instruments. Ensure compliance with GLP guidelines and maintain accurate records in LIMS system. Review batch manufacturing records (BMRs) and perform audits as required. Implement QMS procedures to ensure product quality and regulatory compliance. Collaborate with cross-functional teams to resolve quality issues.

Primary Skills Strong expertise in SAP QM module implementation, configuration, and support within SAP S/4HANA or ECC. Experience in setting up inspection types, quality notifications, results recording, and usage decisions for incoming, in-process, and final inspections. Knowledge of quality planning, quality inspection, quality control, and quality certificates in manufacturing and procurement processes. Hands-on experience in integrating SAP QM with MM (Materials Management), PP (Production Planning), and SD (Sales & Distribution) for quality compliance. Expertise in quality management master data such as inspection plans, sampling procedures, catalogs, and characteristic control. Ability to configure vendor evaluation, supplier quality management, and audit management within SAP QM. Strong understanding of corrective and preventive actions (CAPA), deviation handling, and non-conformance management. Experience in quality notifications, complaint handling, and integration with SAP Workflow for approvals and corrective actions. Ability to troubleshoot and resolve SAP QM issues, optimize system performance, and provide end-user training. Secondary Skills Basic understanding of SAP EHS (Environment, Health, and Safety Management) for compliance reporting. Knowledge of statistical process control (SPC), Six Sigma, and Lean Quality methodologies. Experience with LIMS (Laboratory Information Management Systems) integration with SAP QM. Familiarity with automation tools, Fiori apps, and SAP Business Workflow for enhanced quality process management. Strong analytical and problem-solving skills for data analysis, reporting, and dashboard creation in SAP QM. Ability to work with cross-functional teams including production, procurement, sales, and regulatory compliance teams.

Desired Candidate Profile 5-10 years of experience in LIMS development, testing, or deployment. Required Skills & Experience Development experience with Labware LIMS (Laboratory Information Management Systems) Should have Chromeleon application Support experience. Should have Labvantage LIMS experience. Should know master data configuration for various type of objects, especially test methods Should be able to configure complex calculations and set up Groovy calculations in test method.

Key activities are(leads to generate new business, client requirement quotation, follow-ups AMC Client, Use CRM ( ZOHO & Lims ) software, Payment follow-up, RFQ, Maintain marketing report)

Job Description 10+ year of experience in Design, configuration, testing, and deployment of LabWare Products Should have experience in design and implement interfaces with external applications Should have strong working experience of subroutines, LIMS Basic Experience in instrument integration with the LabWare products Interface with customer to gather User Requirements Provide consistent OOB designs for clients and avoid excessive use of LIMS Basic Be able to create and design blueprints for the conceptual system before any development or configuration begins Should have good experience in SQL. Should have the ability to develop complex queries and scripts. Should have good understanding of server architecture Good Experience in Crystal Reports. Be able to conduct code reviews of others against the LabWare configuration guidelines Participate in Gap Fit and provide inputs related to design and architecture Good communication knowledge Ability and willingness to work independently and with a team Train and mentor team members

Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future. Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector. We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you. Why Join Us? Innovation-Driven Environment : Work on cutting-edge technologies in precision and implantable medical devices. Growth Opportunities : Be part of a strategic growth initiative for one of the leading pharmaceutical companies and be part of creating a legacy. Collaborative Culture : Engage with a team of dedicated professionals committed to making a difference in healthcare. Impactful Work : Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond. Manufacturing in India : Support the vision of the Government of India by contributing to domestic production and innovation in the MedTech sector. Join us at Alkem MedTech and help shape the future of healthcare technology. Purpose of the role: The Microbiologist is responsible for ensuring the sterility of orthopedic knee and hip joint implants, monitoring microbiological processes, conducting microbiological testing, and ensuring compliance with relevant standards and regulations. This role involves conducting environmental monitoring, sterilization validation, and contamination control to ensure product safety and quality. Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples in accordance with GMP (Good Manufacturing Practices) and ISO standards. Conduct sterility testing, endotoxin testing, and bioburden testing of implants and related materials. Monitor and maintain environmental controls in cleanrooms, including air, surface, and personnel monitoring. Validate sterilization processes (e.g., Ethylene Oxide, Gamma Radiation) and perform routine sterilization cycle monitoring. Investigate microbial contamination events and implement corrective and preventive actions (CAPA). Maintain microbiological laboratory instruments, ensuring calibration, validation, and proper maintenance. Prepare detailed reports on microbiological findings, test results, and environmental monitoring data. Ensure compliance with regulatory requirements including FDA, ISO 13485, and EU MDR. Provide microbiological support during audits and inspections by regulatory bodies. Develop and review microbiological standard operating procedures (SOPs) and test protocols. Train and mentor junior staff on microbiological procedures and aseptic techniques.

Scientific Business Analyst (Associate) – ELN What you will do This role involves working 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 scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. 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. 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 landmarks 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: Bachelor’s degree with 0 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 4 - 7years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: Experience with Agile software development methodologies (Scrum) Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience supporting ELN/LIMS platforms in biopharma 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Roles and Responsibilities Conduct analytical testing using various instruments such as GC, HPLC, XRD, LIMS, Empower3, and other relevant equipment. Develop and validate new methods for biochemistry tests to ensure accuracy and reliability. Collaborate with cross-functional teams to resolve issues related to test results or instrument malfunctions. Maintain accurate records of test data, instrument calibration, and maintenance schedules. Participate in continuous improvement initiatives to optimize laboratory processes. Desired Candidate Profile 2-7 years of experience in a similar role within the pharmaceutical industry. MSC or B. pharm or M pharm Strong understanding of biochemistry principles and techniques including chromatography (HPLC), spectroscopy (GC), microscopy (XRD), mass spectrometry (LIMS). Proficiency with analytical instruments such as LIMS software for data management. API Experience will not be considered

Job Description: Performing Stability Analysis. Performing Method transfer/ Method Validation Analysis. Calibration and validation of instruments / equipment's Analysis. Preparation of Method Transfer Protocols (MTP), Method Transfer Report (MTR), Method of analysis (MTH), Test Data Sheet (TDS) for Stability Analysis and Method transfer / Validation any document related to stability analysis, method transfer / method validation in compliance with current guidelines Preparation of departmental SOPs in compliance with current guidelines. Preparation of validation protocols in compliance with current guidelines. Entry of stability sample results in LIMS / SAP. Handling of LSCMS Software.

We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Junior GMP Consultant - QC & QA" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below: Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts. Role & responsibilities: Adequate experience and well versed with Quality Control and Quality Assurance systems and procedures in accordance to regulatory standards. Hands on experience in handling HPLC, GC, UV, FTIR, etc., worked on LIMS, audit trail, CSV , familiarity with GMP, GLP, EUGMP and ICH guidelines, Should have exposure working in formulations like oral solids dosage form (OSD), injectables, etc. Experience: Min 5-10 years experience in quality control & Quality Assurance in pharmaceutical industry. Knowledge & Skills Candidate should have exposure working in QC/QA laboratory in Regulated companies. Well versed with Quality Management systems/procedures Thorough knowledge of testing Raw materials, finished product, Packing materials and handling of key instrumentation like HPLC (auto sampler), GC, dissolution testing. Well versed with QC systems & procedures, audit trail review of HPLC, GC and have knowledge of computer system validation related to QC instruments. Familiarity with GMP, GLP, EUGMP and ICH guidelines. Familiar with stability management and calibration Well versed in carrying out Analytical Method validation/verification, Analytical tech transfers. Fluency in English and good communication written and verbal. Job responsibility: 1)To assist project lead in reviewing the QC systems, documentation and practices for client. 2) Participate in Supplier audits at various sites 3) Maintaining GMP data base and preparation of SOPs 4) Ready to do extensive travelling to visit Client sites and supplier audits (domestic & international) Preferred candidate: Candidates based only in Mumbai/Navi Mumbai will be preferred. 6. Qualifications: Education: A masters degree in Pharmaceutical Sciences or a master's degree in Analytical Chemistry Skills and Competencies: Strong analytical and problem-solving skills. Attention to detail and accuracy in testing and documentation. Proficient in the use of laboratory equipment and software. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak, Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

Develop and implement enhancements, revisions to meet the needs of the client. Extensive experience developing solutions in Thermo Fisher Sample Manager LIMS. Skills - LIMS, Thermofisher, C#, VGL NP - Immediate to 15 Days

Must have experience in C#/ .Net Must have exp in VGL Must have exp LIMS Must have exp in Thermofisher

Role & responsibilities 1. Shall have an exposure to SRA inspections like USFDA, EU, TGA etc. 2. Should have experience of implementation and handling and troubleshooting any of QAMS software like Trackwise /calibre(DMS, QMS), nichleone(TMS), LIMS,SAP etc. 3. Should have experience of handling QAMS notifications like change control, deviation, OOS, incidents, risk assessment, market complaint, etc. 4. Should have an experience of MRM/ IPQA / participation in internal. Preferred candidate profile B. Pharm/M. Pharm with 4+yrs of experience in implementation of QAMS software, LIMS, SAP, nichleone.

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 - 1. Identify the calibrations as per the method protocol and the instruments as per schedule. 2. Prepare calibration and working standards as per requirement. 3. 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

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control.

About the Role We are seeking a highly skilled and experienced Senior Manager, Software Engineering to lead our Healthcare product based client. In this role, you will be responsible for managing multiple software development teams, collaborating with stakeholders across geographies, and ensuring the delivery of high-quality, scalable, and cloud-native applications. You will work closely with engineering leadership at our Palo Alto headquarters , requiring a few overlap hours to ensure smooth collaboration. This is an excellent opportunity for a technically strong leader who has grown from a hands-on development background and is passionate about building robust, cloud-native solutions in a fast-paced and mission-driven environment. Key Responsibilities Leadership & Team Management : Lead and mentor engineering teams, ensuring high performance, technical excellence, and career growth for team members. Collaboration with Global Teams : Work closely with engineering leadership and cross-functional teams both in India , and at our Palo Alto HQ , ensuring alignment with company goals and engineering best practices. Technical Strategy & Execution : Drive the technical roadmap and architecture for cloud-native applications, ensuring scalability, performance, and security. Development & Best Practices : Foster a strong engineering culture with an emphasis on CI/CD, test automation, and DevOps practices . Cloud & Containerization : Build and maintain applications in a containerized environment (Kubernetes, AWS preferred) , ensuring efficient deployment and scaling strategies. Full Stack & Backend Development : Guide teams in Full Stack and Backend development using React, Java, and RESTful APIs . Quality & Compliance : Ensure high code quality, reliability, and test automation to meet regulatory and business requirements. Required Qualifications 12+ years of experience in software engineering , with at least 3+ years in a leadership role managing multiple teams. Hands-on experience in Full Stack or Backend development with technologies such as React, Java, and RESTful APIs . Strong expertise in building cloud-native applications in a containerized environment (Kubernetes, AWS preferred) . Experience with CI/CD pipelines and a strong test automation mindset . Excellent communication and written skills , with the ability to collaborate effectively with global teams, including leadership at Palo Alto HQ . Ability to manage distributed teams and work in a fast-paced, highly regulated environment . Nice to Have Prior experience in the Life Sciences industry. Experience working with Laboratory Information Management Systems (LIMS), LabVantage preferred . Familiarity with regulated environments such as HIPAA .

Role - CSV Consultant Exp - 4+ Years Skills - CVS , CAPA, Gamp, Gxp, SAP / LIMS / LABWARE Permanent: Harjai Computers Pvt.LTD Location: Mumbai Work location - WFO Mode of working- 5 days, Monday to Friday Interview Mode - VC round

Pragyan School is looking for PGT Informatics Practices to join our dynamic team and embark on a rewarding career journey. A Teacher is responsible for delivering lessons and facilitating learning in a classroom setting This includes planning and delivering lessons, assessing student progress, creating a positive and engaging learning environment, and communicating with students, parents, and other stakeholders The ideal candidate should have a strong understanding of the subject matter they are teaching and the ability to effectively communicate complex ideas to students Additionally, excellent interpersonal and organizational skills, a commitment to student learning and development, and a growth mindset are essential for this role

Job description Job Title: Desktop Support Engineer | Pharma Industry | Bangalore /Hyderabad Location Company: Instrumentation and Control Solutions (ICS) Website: www.ics-india.co.in Location: Bangalore/Hyderabad Experience: 2-8 years (Pharma Industry experience mandatory) Qualification: BE/B.Tech/ Any Graduation Key Responsibilities: Maintain inventory of manufacturing automated systems, including PLCs and SCADA systems. Install and maintain computer hardware and peripherals. Install and upgrade operating systems and computer software. Troubleshoot networking and connection issues. Provide recommendations for software or hardware upgrades. Assist in 21 CFR Part 11 compliance assessments during computerized system selection. Prepare and maintain IT-related SOPs for Manufacturing Automated Systems. Participate in the qualification and validation of automated systems from an IT perspective. Prepare daily reports and manage manual backups (weekly/monthly/yearly). Manage service and incident requests via the help desk dashboard. Skills Required: Strong technical knowledge. Basic understanding of computer systems and networks. Eagerness to learn new technologies and processes. Why Join Us? Work with a reputed MNC Pharmaceutical Client. Be part of a dynamic team focused on cutting-edge technology in manufacturing automation. Enjoy a collaborative and growth-oriented work environment. Application Process: Interested candidates can share their updated resumes at hr@ics-india.co.in or contact us at 9109102346 for further details. Note: This is a full-time position requiring candidates with prior experience in the pharmaceutical industry. Connect me on LinkedIn- www.linkedin.com/in/nikita-sen-2a9565114