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4.0 - 7.0 years

2 - 3 Lacs

Jodhpur

On-site

Job title – Sr. Chemist Department – Wet Chemistry lab Reporting to – Manager (Wet Chemistry) Summary of the role – To lead and oversee chemical analyses in the wet chemistry laboratory, using classical and instrumental methods to ensure the accuracy and compliance of results. The Senior Chemist will also support method validation, compliance, and training of junior staff. This role requires strong analytical skills, with knowledge of NABL and ISO/IEC 17025:2017standards. KEY RESPONSIBILITIES Sample Analysis: In depth sample analysis knowledge (Titration, Gravimetric, Standardization, Nutritional profiling & wet chemical Instrumentation clarity with specification, Regulations & Methods etc Sample Analysis & Reporting and maintained TAT. Conduct and supervise classical wet chemistry techniques Wet lab Operation & Maintenance Perform advanced wet chemistry analyses as per FSSAI,IS,BIS,AOAC,USP,EP,JP,IP,API etc Testing performs as per applicable methods, customer defined method, and in-house method. Calibration & Intermediate check of Instruments (applicable instruments) Clarity about titration techniques, hands on experience in FTIR, UV, Refractometer, Polarimeter, Viscosity, Fat & Protein extraction, Melting point, Dissolution, Disintegration, Bomb calorimeter, Water activity, Karl fisher ,Water testing etc Maintain the records for verifications, intermediate checks, performance verification, preventive maintenance and history record of equipment’s / instruments used in Instrument laboratory (applicable instruments & Monitoring to Junior Chemist & Chemist) Maintain detailed instrument logs and ensure readiness for audits trials. Review and verify the records for receiving, handling, and storage and review of Chemicals, reagents, and indent Prepare and check work instructions, SOPs, STPs, validation protocols, and validation reports. Perform and verify the sampling records. Method Development & Validation Develop and validate analytical methods international standards in compliance with regulatory requirements Verification, MOU Calculation SOP & STP Preparation & finalization Participate in setting up new testing capabilities and validation protocols. Certified reference material Handling & Maintenance Data Management & Indent Process raw data, perform calculations, and generate analytical reports . Maintain records in accordance with GLP and ISO 17025 requirements. Record and interpret analytical data accurately. Ensure proper documentation in laboratory notebooks or LIMS (Laboratory Information Management System). Collaborate with other chemists and departments to meet testing deadlines. Review analytical data and reports for completeness, accuracy, and compliance before submission. Maintain accurate and traceable records of sample receipt, processing, and analysis Check all Indent, chemicals, reagents, CRM, glassware, consumable items etc. before purchase. Compliance & Quality Control: Participation in ILC, IQC, and Professional testing Participation in Internal and external audits Calculation of Measurement of Uncertainty (MoU) Follow GLP (Good Laboratory Practices),5S & Safety guidelines. Perform analysis in accordance with regulatory standards (e.g., FSSAI, NABL, EIC, AYUSH, APEDA, Tea Board, International Methods etc.). Support internal audits and quality assurance checks. Knowledge of complete scope, guidelines (As per applicable Authorized signatory) Safety & Housekeeping: Ensure adherence to laboratory safety protocols. Monitor chemical inventory, lab cleanliness, and waste disposal practices. Team Collaboration & Learning: Work under the supervision of Chemist/Senior Chemists /Assistant Managers/Managers. Participate in training sessions and stay updated with new analytical methods and technologies. To carry out any other work assigned by Lab Head/ Management. Coordinate with team members and senior for smooth lab operations. Report any deviations or non-conformities promptly. Training ,Mentoring & Skill Train and mentor junior chemists/Chemist and lab attendant in proper sample handling, instrument usage, and SOP adherence. Act as a technical resource within the team. Strong understanding of global MRL regulations and compliance standards. Excellent problem-solving, data interpretation, and report writing skills Certification & training in GLP , instrumentation , ISO 17025:2017 or regulatory testing . REQUIRED QUALIFICATIONS AND SKILLS Post Graduation/B.Tech in Food Technology/Chemistry/Bio Technology or Equivalent Minimum 4–7 years of hands-on experience in an analytical lab.For PHD (experience needed 2 year minimum) Experience in a NABL-accredited or ISO 17025-compliant lab is preferred. Analytical mindset with Attention to details WORKING CONDITIONS OR LOCATION On-Site Sangariya Fanta, Jodhpur, Rajasthan

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0 years

5 - 10 Lacs

Jodhpur

On-site

Job Summary: We are seeking a highly motivated and detail-oriented Quality Assurance Professional to join our laboratory team. This role is crucial in ensuring the continuous implementation, maintenance, and monitoring of our quality management system, adhering to national and international standards. The ideal candidate will play a pivotal role in upholding regulatory compliance, driving continuous improvement, and ensuring the integrity of all laboratory operations. Key Responsibilities: Quality System Management: Actively participate in and support all quality assurance-related activities. Implement, maintain, and monitor the effectiveness of the Quality Management System (QMS) in compliance with ISO/IEC 17025:2017, NABL guidelines, FSSAI, EIC, APEDA, AYUSH, GLP, Commodity Boards (e.g., Tea Board), and other relevant regulatory body requirements. Ensure systematic control and management of all QMS documents and records, including preparation, review, issuance, revision, and updates. Training & Development: Identify, plan, and execute internal and external training programs for laboratory personnel. Review and compile comprehensive training records. Corrective & Preventive Actions (CAPA): Monitor the effective implementation and verification of corrective actions (CA) and preventive actions (PA). Systematically resolve complaints and non-conforming work, actively participating in complaint closure actions. Technical Review & Oversight: Review and maintain records for method development, validation, and verification. Review test reports, calibration, and validation certificates for accuracy and compliance. Vendor & Equipment Management: Perform qualification and ongoing evaluation of vendors providing products and services to the laboratory. Plan, conduct, and monitor equipment calibration, validation, intermediate checks, and maintenance activities. Quality Control & Proficiency Testing: Plan, conduct, and participate in inter-laboratory comparison (ILC), proficiency testing (PT), and internal quality check (IQC) programs, ensuring meticulous record maintenance. Audits & Compliance: Assist and actively participate in the execution of internal and external audits, as well as Management Review Meetings (MRM). Support the preparation for and participation in customer and regulatory audits, visits, and inspections, ensuring successful closure of any non-conformances raised. Customer & Information Management: Review, assess, and evaluate customer feedback to drive improvements. Assist in LIMS (Laboratory Information Management System) operation and ensure its compliant implementation. Circulate critical regulatory and laboratory information, circulars, notices, newsletters, and recent updates/guidelines to all relevant company personnel. Risk Management & Continuous Improvement: Identify, assess, and mitigate risks, while also developing and verifying the implementation of opportunities for system and process improvement. General Support: Perform other duties as assigned by the Lab Head or Management. Qualifications: Education: Master's degree in Biotechnology/Microbiology/Food Technology/Chmeistry or a related discipline. Experience: 5-8 of progressive experience in Quality Assurance within a NABL accredited. Technical Knowledge: In-depth understanding and practical experience with ISO/IEC 17025:2017. Familiarity with NABL guidelines, FSSAI, EIC, APEDA, AYUSH, GLP, and other relevant regulatory requirements (e.g., specific to food, pharma, tea, etc.). Proficiency in laboratory quality control principles, method validation, and equipment calibration. Experience with LIMS operations is highly desirable. Skills: Strong analytical and problem-solving skills. Excellent communication (written and verbal) and interpersonal skills. Ability to conduct effective training programs. Meticulous attention to detail and strong organizational skills. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint). Ability to work independently and collaboratively within a team.

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0.0 - 2.0 years

0 Lacs

Jodhpur, Rajasthan

On-site

Job title – Sr. Chemist Department – Wet Chemistry lab Reporting to – Manager (Wet Chemistry) Summary of the role – To lead and oversee chemical analyses in the wet chemistry laboratory, using classical and instrumental methods to ensure the accuracy and compliance of results. The Senior Chemist will also support method validation, compliance, and training of junior staff. This role requires strong analytical skills, with knowledge of NABL and ISO/IEC 17025:2017standards. KEY RESPONSIBILITIES Sample Analysis: In depth sample analysis knowledge (Titration, Gravimetric, Standardization, Nutritional profiling & wet chemical Instrumentation clarity with specification, Regulations & Methods etc Sample Analysis & Reporting and maintained TAT. Conduct and supervise classical wet chemistry techniques Wet lab Operation & Maintenance Perform advanced wet chemistry analyses as per FSSAI,IS,BIS,AOAC,USP,EP,JP,IP,API etc Testing performs as per applicable methods, customer defined method, and in-house method. Calibration & Intermediate check of Instruments (applicable instruments) Clarity about titration techniques, hands on experience in FTIR, UV, Refractometer, Polarimeter, Viscosity, Fat & Protein extraction, Melting point, Dissolution, Disintegration, Bomb calorimeter, Water activity, Karl fisher ,Water testing etc Maintain the records for verifications, intermediate checks, performance verification, preventive maintenance and history record of equipment’s / instruments used in Instrument laboratory (applicable instruments & Monitoring to Junior Chemist & Chemist) Maintain detailed instrument logs and ensure readiness for audits trials. Review and verify the records for receiving, handling, and storage and review of Chemicals, reagents, and indent Prepare and check work instructions, SOPs, STPs, validation protocols, and validation reports. Perform and verify the sampling records. Method Development & Validation Develop and validate analytical methods international standards in compliance with regulatory requirements Verification, MOU Calculation SOP & STP Preparation & finalization Participate in setting up new testing capabilities and validation protocols. Certified reference material Handling & Maintenance Data Management & Indent Process raw data, perform calculations, and generate analytical reports . Maintain records in accordance with GLP and ISO 17025 requirements. Record and interpret analytical data accurately. Ensure proper documentation in laboratory notebooks or LIMS (Laboratory Information Management System). Collaborate with other chemists and departments to meet testing deadlines. Review analytical data and reports for completeness, accuracy, and compliance before submission. Maintain accurate and traceable records of sample receipt, processing, and analysis Check all Indent, chemicals, reagents, CRM, glassware, consumable items etc. before purchase. Compliance & Quality Control: Participation in ILC, IQC, and Professional testing Participation in Internal and external audits Calculation of Measurement of Uncertainty (MoU) Follow GLP (Good Laboratory Practices),5S & Safety guidelines. Perform analysis in accordance with regulatory standards (e.g., FSSAI, NABL, EIC, AYUSH, APEDA, Tea Board, International Methods etc.). Support internal audits and quality assurance checks. Knowledge of complete scope, guidelines (As per applicable Authorized signatory) Safety & Housekeeping: Ensure adherence to laboratory safety protocols. Monitor chemical inventory, lab cleanliness, and waste disposal practices. Team Collaboration & Learning: Work under the supervision of Chemist/Senior Chemists /Assistant Managers/Managers. Participate in training sessions and stay updated with new analytical methods and technologies. To carry out any other work assigned by Lab Head/ Management. Coordinate with team members and senior for smooth lab operations. Report any deviations or non-conformities promptly. Training ,Mentoring & Skill Train and mentor junior chemists/Chemist and lab attendant in proper sample handling, instrument usage, and SOP adherence. Act as a technical resource within the team. Strong understanding of global MRL regulations and compliance standards. Excellent problem-solving, data interpretation, and report writing skills Certification & training in GLP , instrumentation , ISO 17025:2017 or regulatory testing . REQUIRED QUALIFICATIONS AND SKILLS Post Graduation/B.Tech in Food Technology/Chemistry/Bio Technology or Equivalent Minimum 4–7 years of hands-on experience in an analytical lab.For PHD (experience needed 2 year minimum) Experience in a NABL-accredited or ISO 17025-compliant lab is preferred. Analytical mindset with Attention to details WORKING CONDITIONS OR LOCATION On-Site Sangariya Fanta, Jodhpur, Rajasthan

Posted 15 hours ago

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3.0 - 8.0 years

0 Lacs

kolkata, west bengal

On-site

As an Implementation Consultant for LIMS in Hyderabad and Kolkata, your primary responsibility will be to deploy software at client sites, involving configuration and programming tasks. You will be working with languages such as .Net, C#, and VGL. Your role will involve delivering technical work, providing high-quality consultancy, and achieving defined performance metrics. It will be essential to engage with customers at all levels, participate in pre-sales activities, and work onsite. To be successful in this role, you should have experience in Laboratory Informatics, particularly in LIMS, ELN, SDMS, and Instrument Integration. Previous exposure to SampleManager and/or Nautilus LIMS is preferred. Proficiency in programming with Microsoft .NET is highly advantageous. A degree in a scientific or information technology field is required. You must be well-organized, able to prioritize tasks, work effectively under pressure, and possess excellent verbal and written communication skills. Being customer-focused and willing to travel up to 50% of the working time annually are crucial aspects of this position. The non-negotiable hiring criteria include experience in customer-facing roles, strong communication skills, and significant relevant experience in the industry or laboratory informatics field. This job entails frequent travel to customer sites and potential remote work from home. Key Skills and Experience: - Industry: Bio-Technology & Life - Role: LIMS, Implementation / Deployment Engineers - Key Skills: LIMS, C#, .NET, VGL, LIMS Implementation, LIMS Deployment, Labware, SampleManager, Nautilus LIMS - Education: B.Sc/B.Com/M.Sc/MCA/B.E/B.Tech If you meet the qualifications and are interested in this role, please send your application to jobs@augustainfotech.com.,

Posted 21 hours ago

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6.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

You should be well versed with SQL queries and have hands-on experience in writing subroutines using LIMS Basic coding, which is LabWare's customized programming language. It is essential that you have worked in support and are familiar with ITIL processes. Experience in working on crystal reports, whether for enhancement or bug fixes, would be highly desirable. Key skills required for this role include LIMS, SQL, LIMS Labware, and ITIL. The job location for this position can be Hyderabad, Bangalore, Chennai, or Pune. The ideal candidate should have a work experience of 6-12 years and be available for a full-time employment opportunity. The work mode is hybrid, and the notice period required is 0-30 days.,

Posted 22 hours ago

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5.0 - 31.0 years

3 - 5 Lacs

Moulivakkam, Chennai

On-site

Job Summary We are seeking an experienced and proactive Lab Manager to oversee the day-to-day operations of our pathology processing lab. The Lab Manager will be responsible for ensuring the lab runs effectively while maintaining the highest standards of accuracy, quality, and compliance. This role involves managing a team of laboratory technicians, ensuring adherence to safety protocols, optimizing workflows, and maintaining operational excellence. Key Responsibilities 1. Operational Management: o Oversee daily lab operations, ensuring timely and accurate processing of pathology samples. o Develop and implement workflows and standard operating procedures (SOPs) to optimize efficiency. 2. Quality Assurance & Compliance: o Competent to handle compliance and ensure all lab processes comply with regulatory and accreditation board requirements (e.g., NABL, CAP). o Implement and monitor quality control measures to maintain high standards of accuracy. o Address and resolve quality issues promptly. 3. Team Leadership: o Manage, train, and mentor laboratory staff, including technicians and support staff. o Schedule shifts and ensure adequate staffing to meet operational demands. 4. Equipment & Inventory Management: o Oversee the maintenance, calibration, and servicing of lab equipment. o Monitor and manage inventory levels of reagents, consumables, and supplies. o Share inputs on procurement for cost-effective sourcing. 5. Reporting & Documentation: o Ensure accurate documentation of lab processes, test results, and incidents. o Prepare and present operational reports to senior management. 6. Safety & Risk Management: o Enforce safety protocols to minimize hazards and ensure a safe working environment. o Conduct regular safety audits and address any non-compliance issues. 7. Stakeholder Collaboration: o Work closely with clinicians, pathologists, and other departments to ensure smooth sample handling, result delivery and closure of complaints. o Act as the point of contact for external audits and inspections. Qualifications and Skills • Education: Bachelor’s or Master’s degree in Medical Laboratory Technology, Pathology, Microbiology, or related fields. • Experience: Minimum of 4–7 years in a pathology lab, with at least 2–3 years in a managerial or supervisory role. • Technical Skills: o Proficiency in handling lab equipment (e.g., analysers, general equipment). o Knowledge of LIMS (Laboratory Information Management Systems). o Strong understanding of pathology workflows and lab safety protocols. • Soft Skills: o Leadership and team management. o Strong problem-solving and decision-making abilities. o Excellent communication and interpersonal skills. ________________________________________ Preferred Qualifications • Certification in quality management systems (e.g., ISO 15189). • Experience with accreditation processes (e.g., NABL, CAP). • Familiarity with lean management or Six Sigma principles.

Posted 22 hours ago

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4.0 - 8.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Line of Service Advisory Industry/Sector Not Applicable Specialism Risk Management Level Senior Manager Job Description & Summary At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformation, co-sourcing, outsourcing and managed services, using AI and other risk technology and delivery models. IA capabilities are combined with other industry and technical expertise, in areas like cyber, forensics and compliance, to address the full spectrum of risks. This helps organisations to harness the power of IA to help the organisation protect value and navigate disruption, and obtain confidence to take risks to power growth. Why PWC At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us. At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firms growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations. Responsibilities Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis) Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR) Mandatory Skills CSV Preferred Skills LIMS/QMS Years Of Experience 4-8 years Education Qualification B.Tech/MBA Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required: Bachelor of Technology, Master of Business Administration Degrees/Field Of Study Preferred Certifications (if blank, certifications not specified) Required Skills Creating Shared Value (CSV) Optional Skills Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Analytical Thinking, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Coaching and Feedback, Communication, Compliance Auditing, Corporate Governance, Creativity, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Embracing Change, Emotional Regulation, Empathy, Financial Accounting + 32 more Desired Languages (If blank, desired languages not specified) Travel Requirements Not Specified Available for Work Visa Sponsorship No Government Clearance Required No Job Posting End Date Show more Show less

Posted 23 hours ago

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0 years

0 - 0 Lacs

Bhilai

On-site

Job Summary: We are seeking a responsible and detail-oriented professional to manage and oversee sample collection operations for our pathology laboratory. The Collection Incharge will be responsible for supervising phlebotomists, ensuring timely and accurate collection of specimens, maintaining cold chain logistics, and coordinating with lab staff to ensure smooth workflow and high-quality service. Key Responsibilities: Supervise and schedule the daily activities of sample collection staff (in-house ). Ensure proper collection, labeling, handling, and transportation of blood and other specimens as per NABL/IATA guidelines. Maintain documentation and logs of collected samples. Oversee cold chain and sample safety during transit to the lab. Ensure proper usage and availability of collection kits and consumables. Provide training and guidance to collection staff on best practices and SOPs. Handle patient/customer queries related to home collection or on-site collection. Collaborate with logistics partners for timely pickups and deliveries. Monitor TAT (Turnaround Time) and report discrepancies to the lab manager. Maintain hygiene, infection control standards, and ensure staff wear appropriate PPE. Address complaints or errors in collection procedures promptly and professionally. Conduct periodic audits and quality checks. Key Skills & Competencies: Strong knowledge of phlebotomy and sample handling protocols. Team leadership and coordination. Excellent organizational and multitasking skills. Basic computer literacy (MS Excel, EMR/LIMS software). Effective communication and problem-solving skills. Knowledge of safety, infection control, and biomedical waste disposal. Educational Qualification: Diploma or Degree in Medical Laboratory Technology (DMLT/BMLT) or equivalent. Certification in Phlebotomy (preferred). Job Types: Full-time, Permanent, Fresher Pay: ₹7,000.00 - ₹8,000.00 per month Work Location: In person

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2.0 - 5.0 years

3 - 4 Lacs

Ahmedabad

On-site

Key Responsibilities:  Perform routine microbiological testing of raw materials, in-process samples, finished products, and water systems (e.g., TOC, endotoxin, bioburden, sterility).  Conduct environmental monitoring (viable and non-viable particle counts, surface swabbing, personnel monitoring) in cleanrooms and controlled areas.  Perform validation activities including media fill simulations, cleaning validation, and method validation.  Identify and investigate out-of-specification (OOS) and non-conformance issues in collaboration with QA/QC.  Maintain accurate and complete microbiological records, logs, and documentation as per cGMP.  Prepare microbial cultures, maintain microbial stock cultures, and carry out identification of microorganisms.  Participate in internal and external audits and assist in CAPA implementation related to microbiology.  Ensure laboratory instruments and equipment are calibrated, maintained, and validated as per schedule.  Assist in the development and revision of SOPs, protocols, and microbiological methods.  Support continuous improvement and training initiatives within the microbiology lab. Key Skills Required:  Attention to detail and strong documentation practices  Analytical and critical thinking  Familiarity with microbiology software systems (LIMS, etc.)  Ability to work independently and in teams  Good communication and reporting skills Qualification:  B.Sc./M.Sc. in Microbiology, Biotechnology, or related field.  2–5 years of experience in a pharmaceutical microbiology lab, preferably sterile manufacturing.  Good knowledge of current Good Manufacturing Practices (cGMP), GLP, and regulatory guidelines (e.g., WHO, EU, USFDA).  Hands-on experience in microbial limit testing, sterility testing, and EM techniques.  Proficiency in data recording, documentation, and handling microbiology lab equipment. Job Type: Full-time Pay: ₹30,000.00 - ₹40,000.00 per month Schedule: Day shift Experience: Microbiology: 2 years (Preferred) pharmaceutical microbiology lab: 1 year (Preferred) sterile manufacturing: 1 year (Preferred) microbial limit testing: 1 year (Preferred) sterility testing: 1 year (Preferred) EM techniques: 1 year (Preferred) Work Location: In person

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10.0 years

0 Lacs

Tamil Nadu, India

Remote

Tulip Sales Engineer – Sr Manager (India) Work Mode: Remote/ Hybrid Required Exp: 10+ years Shift Timings: Minimum 4 hours overlap required with US team Skills/Experience Desired:  You have experience in Manufacturing or Industrial operations.  You are passionate about Digital Transformation, and are focused on driving value for clients  You are always looking at ways to improve solutions, implement best practices, and improve our methodology and quality of execution within the Digital Transformation Engineering Team  You are a natural team player that understands what it is to work in an agile environment  BS degree in Engineering (Mechanical, Industrial, Chemical, Computer Science). MSC degree is a plus  5-10 years of enterprise SaaS presales experience  10+ years of valuable experience in Manufacturing or Industrial operations  Experience in selling to or working with manufacturing companies to help them with their digital transformation journey  Excellent business writing, presentation and communication skills. You can speak, write and comprehend the English language fluently.  Preferred experience with systems such as MES/MoM, LES/LIMS, WMS, QMS, ERP, SPC, IIoT, etc  Team player with strong interpersonal skills and ability to take a leadership role to eventually manage a team.  Have passion for technology and speak fluently about current trends related to SaaS, PaaS, IIoT, and cloud solutions.  Detail-oriented individual with the ability to quickly assimilate and apply new concepts, business models, and technologies. Key Responsibilities: In order to succeed, you will:  Consult customers and prospects to prepare their companies for digital transformation.  Work closely with our sales team to effectively progress opportunities through the pipeline and secure the technical wins  Develop, present and deliver high-impact technical demonstrations of the Tulip solutions daily (Demos, technical presentations, technical discussions, etc.)  Clearly articulate the benefits of Tulip's applications to all levels including but not limited to line of business managers; level executives, and IT  Provide comprehensive technical presales support  Identify and collaborate with prospect’s technical stakeholders to align around Tulips solution and secure commitments needed to ensure a technical close  Manage and maintain internal requests using our internal systems.  Facilitate brainstorming sessions and consensus building  Perform needs gathering and requirement analysis for new customers  Analyze and track reseller competencies and technical delivery.  Help develop and answer RFx (RFI, RFP, RFQ), technical assessments, technical and security questionnaires  Lead in the scoping and estimation of implementation

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1.0 - 3.0 years

0 Lacs

Mumbai, Maharashtra, India

On-site

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Compile annual product quality reviews (APQRs) per applicable SOP&aposs Collect, analyse and summarize product review data correctly and completely in timely manner. Job Responsibilities Perform Annual Product Quality Reviews (APQRs) compilation as This includes the following at minimum, as per SOP: Manufacturing Process Overview Batches Released / Rejected APIs, Excipients Changes Test Method and Specification Manufacturing / Process Validation, Equipment and Utilities Qualification Sterility Validation / Qualification (If applicable) Packaging Component Deviations/Changes Compendial Review Deviations Critical In-Process Attributes Analytical Test Results Recalls and Field Alerts, Returns Retention Samples Review Technical Agreements (as appropriate) Marketing Authorizations Variations and Post Market Commitments (as appropriate) Complaints Stability Conclusion and Product Rating Concerns, Recommendations and Issues for Follow-Up Perform complete and correct transactions of the data as per SOP / WIs. Summarize and trend analytical data from LIMS or other acceptable systems. Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review. Co-ordinate with Project Leader(s) QA Product Review / Manager for completion of the projects. Compile the APQRs within required timelines to ensure that there is adequate time for approvals. Responses to Project Leaders queries for APQR summary reports as required. Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education B.Pharm/ M.Sc./ M. Pharm. Knowledge, Skills and Abilities Excellent technical writing, communication skills and interpersonal skills. Have the Good Academic Record from 10th Class Onwards. Demonstrated cGMP knowledge. Maintain the tracking system for compilation and review of assigned APQRs Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance. Works in a safe manner collaborating as a team member to achieve all outcomes. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Perform all work in support of the Corporate values Experience Minimum 1-2 years in the pharmaceutical industry with an emphasis on Quality Assurance. At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

Posted 2 days ago

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10.0 - 15.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

Designation - Manager Exp - 10-15 years Location - Hyderabad Research Center Industry experience - CRO & CDMO Only. Key Responsibilities: GLP Compliance in Biology Function: Ensure that in vivo and in vitro biology studies conducted as part of Integrated Drug Discovery projects comply with OECD GLP, ISO 9001:2015, and ISO 17025:2017 guidelines. Oversee quality systems and documentation associated with pharmacology, toxicology, DMPK, and other biology-related services. SOP & Documentation Management: Prepare, review, and implement SOPs for biology labs in accordance with global regulatory requirements. Maintain study plan copies, amendments, SOPs, QA records, training documents, and other facility-related documents. Review of GLP Study Data: Review Study Plans/Amendments, Raw Data, and Study Reports for in vivo biology studies (e.g., efficacy, PK, safety) as conducted in IDD programs. Verify data integrity and traceability of scientific results. Training & Induction: Conduct GLP induction and periodic training for scientific and technical staff working in biology labs. Ensure training SOP compliance and maintain training records. Audit Trail & Scientific Software Review: Review and approve audit trails from software used in biology labs (e.g., data capture systems, LIMS, electronic lab notebooks). Internal and In-Process Audits: Plan, conduct, and document audits of biology departments and related QA processes. Identify gaps and drive CAPA implementation to close non-conformances. Change Controls and CAPA Management: Manage quality events including Change Controls, Deviations, CAPAs, and Incidents across IDD biology functions. Equipment Qualification and Calibration Review: Review IQ, OQ, PQ, and calibration records of biology lab instruments (e.g., animal study equipment, analytical tools). Vendor & External Laboratory Audits: Qualify external testing labs and service providers related to biology studies and ensure their ongoing compliance through periodic audits. Controlled Document Management: Handle issuance and retrieval of controlled forms, logbooks, and QA records for biology operations.

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25.0 years

0 Lacs

Ahmedabad, Gujarat, India

On-site

ATS India, operating as Sarla Advantech Pvt. Ltd. (formerly known as Sarla Technologies), is an independent solution provider for Smart Digital Transformation serving 10+ industrial sectors including Pharma, Automotive, Metals, Energy, Chemical, CPG, Infrastructure, etc. With over 25 years of experience. ATS India provides Manufacturing IT Solutions and services with experience in Industrial Automation Software, Manufacturing integration, MES/MOM, and IIOT. Major business areas of operations include Operations Technology (OT) data connectivity, OPC connectivity & MES/IIOT enablement solutions, SCADA Systems, Data Historian, Industrial Analytics solutions, Manufacturing Execution Systems, OT Cyber Security, Industry 4.0 solutions, High availability, and Fault-tolerant servers. Qualification BE/BTECH or MSC graduate in Computer science, IT, Instrumentation, Electronic, Electrical. Job Requirement Min. 2-5 years’ experience in Sales & Business development of Industrial Automation or IT domain.. Proven track record of selling SCADA, OPC Software, Historian, MES, Industrial IOT, Industrial Analytics, LIMS etc. Conceptual & Functional knowledge of Industrial connectivity protocol, Data Historian, IIOT, MES, Analytics, etc. Exposure to Long sales Cycle & customer account Management is essential. Candidate must possess good sales skills along with relationship building internally and externally, Networking, Persuasion of opportunities, Prospecting, Sales planning, Territory management, Market Knowledge, etc. Adept at handling objections and commercial negotiations. Role Description Regional sales: Gujarat and MP Software Product sales SI, ISV, IIOT companies. Software solution business to End Users focusing on solutions like IT-OT Integration, SCADA Systems, Data Historian, MES, Industrial IOT etc. Meeting monthly, quarterly and Annual Revenue target. Forecasting and planning monthly & quarterly targets, opportunity pipeline, lead qualification, etc. Channel Management and Growth in designated region. Customer relationship management in close coordination with Projects & Support team Keep up with Technology / Industry knowledge and Network with Customers / Partners / Industry forums to grow Company positioning.

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10.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

We are looking for an experienced Senior Full Stack Java Developer to join our dynamic and fast-paced team. This is an exciting opportunity to work on enterprise applications using the latest technologies while contributing to impactful projects in healthcare and life sciences. Key Responsibilities Develop, enhance, and maintain enterprise Java applications with full-stack capabilities. Design and manage relational and NoSQL database schemas, ensuring efficient data modeling and processing. Work on UI development using JavaScript and popular frameworks/libraries like JQuery. Collaborate in Agile teams to deliver high-quality solutions with test automation and CI/CD practices. Utilize cloud and container technologies like AWS, Docker, and Kubernetes. Contribute to LIMS (LabVantage or STARLIMS) development projects (healthcare experience is a plus). Stay updated with emerging technologies (e.g., GitHub Copilot, ChatGPT) and contribute to open-source initiatives. Qualifications 10+ years of software development experience, with 5+ years in Java enterprise full-stack development. 3+ years of experience in JavaScript with UI frameworks/libraries. Proficiency in SQL for large-scale RDBMS (Oracle preferred). Experience with XML, JSON, and data modeling for RDBMS and NoSQL. Hands-on experience with Docker, Kubernetes, and AWS. Bachelor’s degree in Computer Science, Electrical Engineering, or Biosciences (or equivalent). Prior healthcare/LIMS domain experience is an added advantage. Why Join Us? Work with cutting-edge technologies in a collaborative environment. Opportunity to contribute to meaningful healthcare and life sciences solutions. Be part of an innovation-driven team adopting AI tools like GitHub Copilot and ChatGPT. Apply Now If you’re an experienced full-stack Java professional passionate about technology and innovation, we’d love to hear from you.

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10.0 years

5 - 7 Lacs

Hyderābād

On-site

Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. Job Description The Advanced Technologies team is looking for a couple of innovative software engineers to build and scale our Laboratory Information Management Systems (LIMS) for clinical diagnostic products. As a member of the team, you will: Scale the systems that take patient samples from order to result in a multi-product clinical laboratory. Explore emerging technologies such as LLM for enhancing our efficiency to process customer orders coming in various forms. Develop microservices applications for various capabilities and system integrations. Communicate and vet design proposals with cross-functional teams and incorporate feedback prior to implementation. Code for efficiency, reusability, scalability, and all other abilities by following existing frameworks and practices or creating new ones when needed. Develop and maintain automated tests for regular releases. Qualifications 10 years of experience in software development with at least 5 years in Java enterprise application full stack development. 3 years of experience in JavaScript, using UI frameworks or libraries, such as JQuery. Hands-on experience with data modeling, developing schemas, such as relational databases, XML and JSON, data management and processing with RDBMS and NoSQL data stores. Highly proficient in using SQL to generate reports from a large RDBMS, such as Oracle. Experience with Docker, Kubernetes, and Amazon Web Services. Experience with LIMS development, such as LabVantage or STARLIMS in healthcare industry is a plus. Experience working in a fast-paced environment leveraging an agile development framework, understanding of test automation and continuous integration. Curious of new technology, experience of using Github Copilot, ChatGPT or other AI tools, experience of contributing to Open Source projects will also make you standup among the candidates A Bachelor degree or equivalent in CS/EE or a discipline of Biosciences is required Additional Information To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants . Please visit our career page at: http://www.guardanthealth.com/jobs/

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8.0 years

0 Lacs

Mumbai Metropolitan Region

Remote

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Join Veeva as we modernize software for the life sciences industry. We are bringing to market a modern cloud solution designed to optimize laboratories with increased efficiency and productivity by streamlining processes. Join the team that will partner with our customers to implement one of Veeva’s newest products - Veeva Vault LIMS. Passionate about bringing disruptive technology to customers and have novel ideas for successful GMP software implementation? This role will allow you to help our clients to drive new product adoption through successful implementations. This is a remote, full-time permanent role with Veeva. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements. Qualified candidates must be legally authorized to be employed in India. Veeva does not provide sponsorship for employment visas for this position. What You’ll Do Lead life sciences customers in the implementation of Vault Quality Suite applications to ensure customer success Guide customers on how to enhance their platforms with an innovative approach through cloud-based software applications Define strategies and implementation programs for deploying Veeva Vault LIMS across organizations Project management including resource planning, leading and motivating a cross-functional team, and project budget tracking and forecasting Primary customer liaison managing communication between the project team, customer, external partners and internal stakeholders Mentor project team and junior consultants in the Professional Services organization Represent Professional Services across multiple engagements and workstreams (e.g., solution design and configuration, data migration, systems integration, etc.) Requirements 8+ years of experience implementing and/or supporting LIMS systems Proven track of delivering subject matter expertise on implementation methodology and driving best practices Demonstrated expertise in customer leadership and fostering a collaborative team environment Demonstrated work history in stakeholder management, critical thinking skills, ability to conduct complex and technical communications in a wide variety of settings and audiences, and the determination to see client success with solution implementation Ability to travel upon business requirements Nice to Have Understanding of business requirements, scientific data, compliance considerations, and processes for laboratory information management, life sciences compliance, and/or computer systems validation Experience implementing Laboratory Information Management Systems for life sciences as a consultant, business, or IT representative Direct experience with systems such as LabWare, SQL LIMS, LabVantage, StarLIMS, SampleManager, SmartLab, BIOVIA, Nugenesis, Empower, Laboratory Information Manager System, QMS, ELN, LIMS, and other informatics or similar systems Consulting experience SaaS/Cloud experience Perks & Benefits Stock bonus % Health & wellness programs Life Assurance Veeva charitable giving program Additional annual leave over Christmas break Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

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5.0 years

0 Lacs

Noida, Uttar Pradesh, India

On-site

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

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5.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

Our technology services client is seeking multiple LIMS Specialist – Sample Manager to join their team on a contract basis. These positions offer a strong potential for conversion to full-time employment upon completion of the initial contract period. Below are further details about the role: Role: LIMS Specialist – Sample Manager Experience: 5+ Years Location: PAN India Notice Period: Immediate- 15 Days Mandatory Skills: Labvantage, LabWare, SampleManager, StarLIMS, Empower, Lab Management Systems, Caliber LIMS, AR_VR_MR Job Description: Configure and maintain Sample Manager LIMS v123 for battery testing workflows including jobsampletest hierarchies Implement and support DBDS features for sample build mapping and data archiving Manage and optimize Integration Manager interfaces agents and transformation logic Perform lifecycle management of samples tests and jobs within LIMS Develop and maintain test plans workflows and reporting structures Troubleshoot and resolve performance issues including database indexing and service configuration Collaborate with QA engineering and IT teams to ensure data accuracy and compliance Document SOPs KT plans and training materials for onboarding and support Required Skills Strong experience with Thermo Fisher Sample Manager LIMS v123 and above Proficiency in Integration Manager configuration and troubleshooting Familiarity with DBDS workflows and Oracle SQL Developer Knowledge of C Net Net WCF for customization and service integration Experience with ServiceNow for ticketing and support workflows Understanding of lab operations in analytical physical and chemical domains Preferred Qualifications Bachelors degree in Computer Science Life Sciences or related field Experience in battery testing environments Lead Acid LithiumIon Prior exposure to global manufacturing systems and multisite deployments If you are interested, share the updated resume madhuri.p@s3staff.com

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3.0 - 7.0 years

0 Lacs

telangana

On-site

As a member of our team, your primary responsibilities will include ensuring smooth GxP IT operations and maintaining all-time GxP IT compliance at the site. You will be involved in vendor management, implementing solutions with a focus on project execution and delivery, as well as supporting various business initiatives. Additionally, you will provide application support to meet the needs of the organization. To excel in this role, you should have knowledge of Pharma IT compliance, plant IT operations, IT infrastructure and networking management, computer system validation, data historian, LIMS, cloud computing, MES, and Empower. Your expertise in these areas will contribute to the success of our IT operations and compliance efforts.,

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1.0 - 2.0 years

0 Lacs

Mumbai, Maharashtra, India

On-site

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Compile annual product quality reviews (APQRs) per applicable SOP's Collect, analyse and summarize product review data correctly and completely in timely manner. Job Responsibilities Perform Annual Product Quality Reviews (APQRs) compilation as This includes the following at minimum, as per SOP: Manufacturing Process Overview Batches Released / Rejected APIs, Excipients Changes Test Method and Specification Manufacturing / Process Validation, Equipment and Utilities Qualification Sterility Validation / Qualification (If applicable) Packaging Component Deviations/Changes Compendial Review Deviations Critical In-Process Attributes Analytical Test Results Recalls and Field Alerts, Returns Retention Samples Review Technical Agreements (as appropriate) Marketing Authorizations Variations and Post Market Commitments (as appropriate) Complaints Stability Conclusion and Product Rating Concerns, Recommendations and Issues for Follow-Up Perform complete and correct transactions of the data as per SOP / WI’s. Summarize and trend analytical data from LIMS or other acceptable systems. Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review. Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects. Compile the APQRs within required timelines to ensure that there is adequate time for approvals. Responses to Project Leader’s queries for APQR summary reports as required. Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education B.Pharm/ M.Sc./ M. Pharm. Knowledge, Skills and Abilities Excellent technical writing, communication skills and interpersonal skills. Have the Good Academic Record from 10th Class Onwards. Demonstrated cGMP knowledge. Maintain the tracking system for compilation and review of assigned APQRs Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance. Works in a safe manner collaborating as a team member to achieve all outcomes. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Perform all work in support of the Corporate values Experience Minimum 1-2 years in the pharmaceutical industry with an emphasis on Quality Assurance. At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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1.0 - 2.0 years

0 Lacs

Mumbai, Maharashtra, India

On-site

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Compile annual product quality reviews (APQRs) per applicable SOP's Collect, analyse and summarize product review data correctly and completely in timely manner. Job Responsibilities Perform Annual Product Quality Reviews (APQRs) compilation as This includes the following at minimum, as per SOP: Manufacturing Process Overview Batches Released / Rejected APIs, Excipients Changes Test Method and Specification Manufacturing / Process Validation, Equipment and Utilities Qualification Sterility Validation / Qualification (If applicable) Packaging Component Deviations/Changes Compendial Review Deviations Critical In-Process Attributes Analytical Test Results Recalls and Field Alerts, Returns Retention Samples Review Technical Agreements (as appropriate) Marketing Authorizations Variations and Post Market Commitments (as appropriate) Complaints Stability Conclusion and Product Rating Concerns, Recommendations and Issues for Follow-Up Perform complete and correct transactions of the data as per SOP / WI’s. Summarize and trend analytical data from LIMS or other acceptable systems. Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review. Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects. Compile the APQRs within required timelines to ensure that there is adequate time for approvals. Responses to Project Leader’s queries for APQR summary reports as required. Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education B.Pharm/ M.Sc./ M. Pharm. Knowledge, Skills and Abilities Excellent technical writing, communication skills and interpersonal skills. Have the Good Academic Record from 10th Class Onwards. Demonstrated cGMP knowledge. Maintain the tracking system for compilation and review of assigned APQRs Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance. Works in a safe manner collaborating as a team member to achieve all outcomes. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Perform all work in support of the Corporate values Experience Minimum 1-2 years in the pharmaceutical industry with an emphasis on Quality Assurance. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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9.0 - 12.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Date: 31 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Designation: AQA Reviewer Job Location: Bangalore Department: Analytical Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation . Key Responsibilities Review of analytical raw data (through ELN / manual) generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification. Ensuring, verifying, and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP. Review of Outsourced analytical report. Review of logbooks with respect to all activity performed in the lab. Responsible for taking any other job allocated by Department Head / Department In charge. Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document. Responsible to ensure review and release of raw material and packing material in LIMS/SAP. Responsible to ensure review and release of cleaning samples, inprocess samples, calibration reports and standard qualification reports. Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents. Review the documents for completeness, compliance to good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable Review of all the tests as specified in the specification/Request for analysis /validation protocol/sampling protocol have been carried out Review of all supporting documents like chromatograms, balance print outs, Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable Review of the test results in COA against specification along with other relevant sample information before approval. In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory. Ensuring of conducting regular GMP rounds at Quality Control Laboratory. Involving in the Laboratory incident investigation, review, and approval. Educational Quali fi cation: M. Sc (Life science / Chemistry)/ M. Pharm Technical/functional Skills Good exposure in Enterprise Applications like SAP, Learning Management Systems, Trackwise, and Analytical laboratory Applications like Chromatography and Non-chromatography data Management. Well versed in electronic data audit review. Good Knowledge on handling the application software. Establish good Interpersonal skills with cross-functional teams. Experience: 9 to 12 Years experience in life science industry. Behavioural Skills Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be able to work in team and flexible for working in shifts. Should be a focused employee. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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3.0 years

0 Lacs

Hyderabad, Telangana, India

Remote

Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. Job Description Essential Duties and Responsibilities: Lead a team to design, build, and maintain efficient and scalable software services and applications that deliver value to our customers Mentor and coach a team of software engineers at various experience levels Act as a resource for software developers on policies, procedures and technical issues Develop close relationships and work with business and technical leads, architects, and product owners, based in the US, to ensure the team's work is aligned with business goals and enterprise-level architectural standards, and that the solution delivered is of the highest quality Assess current software development practices to identify and implement process and software improvements Use cutting-edge technologies to promote new ways of solving problems Collaborate with our DevOps team to design, develop, and maintain CI processes for regular and efficient releases Collaborate on architecture and design of new software applications and enhancements of existing applications Serve as an expert technical resource for software architecture and development Perform other related duties as assigned Leadership Qualifications 3 years’ experience managing software development teams in a distributed and global setup, including leadership of both internal and outsourced/offshore development teams 3+ Experience with multi-modal collaboration (in-office, hybrid and remote), and collaboration across time zones 5+ years of experience planning and delivering software projects within and across teams, including resource allocation and managing cross-functional dependencies. Ability to build clear and realistic project delivery plans Superb verbal and written communication skills. Capacity to convey technical considerations to non-technical audiences, understand business drivers and draw impacts for the technical teams, and utilize appropriate tools for each mode of communication. Ability to manage multiple small engineering teams across multiple projects and deliverables. Experience within the healthcare or life sciences sector, familiar with regulatory environment Qualifications 10+ years of software development 8+ years of programming experience in Java 5+ years of experience with HTML/CSS/JavaScript 5+ years of experience developing or using facing RESTful APIs Expertise in data modeling and developing schemas (relational databases, XML/JSON) Experience in developing LIMS Applications, such as LabVantage Experience with Amazon Web Services or similar cloud architectures Experience working in a fast-paced environment leveraging an agile development framework Good understanding of Test Automation and Continuous Integration B.S. or higher degree in computer science, engineering, or related areas Additional Information To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants . Please visit our career page at: http://www.guardanthealth.com/jobs/

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8.0 - 15.0 years

0 Lacs

Bangalore Urban, Karnataka, India

On-site

Job Title: LIMS Support Location: Chennai, Bangalore, Hyderabad, Pune, Noida Experience: 8-15 Years Job Summary We are seeking a detail-oriented and technically proficient LIMS Support with strong knowledge of laboratory quality systems , LV (LabVantage) packages like LV Pharma and LV SaaS , and a passion for technology-driven problem solving . The candidate will support end-to-end implementation and management of laboratory informatics solutions in compliance with global quality and regulatory standards. Key Responsibilities Lead and manage the delivery of LabVantage LIMS implementations and support activities. Collaborate with stakeholders to understand business requirements and translate them into system specifications. Ensure all deliverables meet quality standards and comply with regulatory requirements (e.g., ISO 17025, FDA). Develop technical documentation, SOPs, validation scripts, and user guides. Participate in system configuration, customization, integration, and testing. Provide post-go-live support and contribute to continuous improvement of LIMS processes. Must-Have Skills Proven experience with LabVantage packages, especially LV Pharma and LV SaaS. Knowledge of laboratory quality systems and compliance standards such as ISO 17025, FDA regulations, or GxP guidelines. Strong problem-solving and analytical skills. Excellent communication and collaboration abilities.

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3.0 years

0 Lacs

Pune, Maharashtra, India

On-site

Line of Service Advisory Industry/Sector Not Applicable Specialism Operations Management Level Associate Job Description & Summary At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformation, co-sourcing, outsourcing and managed services, using AI and other risk technology and delivery models. IA capabilities are combined with other industry and technical expertise, in areas like cyber, forensics and compliance, to address the full spectrum of risks. This helps organisations to harness the power of IA to help the organisation protect value and navigate disruption, and obtain confidence to take risks to power growth. Why PWC At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us. At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firm’s growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations. " We are looking for a Senior Data Engineer with deep experience in SnapLogic, SQL, ETL pipelines, and data warehousing, along with at least 3-4 years of hands-on experience with Databricks. The ideal candidate has a strong background in designing scalable data solutions and working across cloud and big data environments. Familiarity with Python is a strong plus. Responsibilities Design, build, and maintain data integration and ETL pipelines using SnapLogic Develop and optimize complex SQL queries to support business analytics and reporting Work with structured and unstructured data in large-scale data warehouse environments Leverage Databricks for advanced data processing, transformation, and analytics Collaborate with data analysts, data scientists, and business stakeholders to gather and understand data requirements Ensure data quality, integrity, and governance across platforms Create clear documentation for data workflows, architecture, and processes Participate in code reviews and promote best practices in data engineering Required Qualifications: 5+ years of experience with SnapLogic in enterprise-level data integration projects 6+ years of experience with ETL pipeline development and data warehousing Strong proficiency in SQL (performance tuning, complex joins, stored procedures, etc.) 3+ years of hands-on experience with Databricks (Spark, Delta Lake, etc.) Solid understanding of cloud data ecosystems and data modeling principles Excellent problem-solving and communication skills Preferred / Nice-to-Have Skills: Experience with Python for scripting or data processing tasks Familiarity with CI/CD practices Knowledge of data governance, privacy, and compliance best practices SAC JD: Solution Design & Development: o Design, develop, and implement SAP SAC solutions. o Create data models, stories, and dashboards in SAC. o Develop custom SAC applications using scripting and advanced analytics features. Data Integration & Management: o Integrate SAC with various data sources including SAP HANA, BW, S/4HANA, and other external sources. o Ensure data accuracy, consistency, and quality in SAC solutions. Stakeholder Collaboration: o Work closely with business stakeholders to gather requirements and translate them into technical specifications. o Collaborate with cross-functional teams to deliver end-to-end analytics solutions. Performance Optimization: o Optimize SAC solutions for performance and scalability. o Troubleshoot and resolve issues related to SAC solutions. Documentation & Training: o Document SAC solutions, including data models, design specifications, and user manuals. o Provide training and support to end-users and other team members. Proficiency in SAP SAC, including data modeling, story creation, and dashboard development. Strong understanding of SAC data connectivity options and integration with various data sources. Experience with SAP HANA, SAP BW, and S/4HANA. Proficient in SAC scripting and advanced analytics capabilities. Solid understanding of data visualization principles and best practices. Mandatory Skills Sets CSV Preferred Skills Sets LIMS/QMS Years Of Experience Required 4-8 years Education Qualifications B.Tech/MBA Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required: Master of Business Administration, Bachelor of Engineering Degrees/Field Of Study Preferred Certifications (if blank, certifications not specified) Required Skills Creating Shared Value (CSV) Optional Skills Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Communication, Compliance Auditing, Corporate Governance, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Emotional Regulation, Empathy, Financial Accounting, Financial Audit, Financial Reporting, Financial Statement Analysis, Generally Accepted Accounting Principles (GAAP) {+ 19 more} Desired Languages (If blank, desired languages not specified) Travel Requirements Not Specified Available for Work Visa Sponsorship? No Government Clearance Required? No Job Posting End Date

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Exploring LIMS Jobs in India

Laboratory Information Management Systems (LIMS) play a crucial role in managing and tracking laboratory samples and data efficiently. In India, the demand for professionals with expertise in LIMS is on the rise, offering a plethora of job opportunities in various industries such as healthcare, pharmaceuticals, research, and more.

Top Hiring Locations in India

  1. Bangalore
  2. Pune
  3. Hyderabad
  4. Mumbai
  5. Delhi NCR

Average Salary Range

The average salary range for LIMS professionals in India varies based on experience and location. Entry-level positions typically start at around INR 3-5 lakhs per annum, while experienced professionals can earn upwards of INR 10-15 lakhs per annum.

Career Path

A typical career path in the LIMS domain may include roles such as: - Junior LIMS Analyst - LIMS Administrator - LIMS Specialist - LIMS Manager - LIMS Consultant

Related Skills

Besides proficiency in LIMS, other skills that are often expected or helpful in this field include: - Laboratory data management - Quality control and assurance - Regulatory compliance - Data analysis and interpretation - Communication and teamwork

Interview Questions

  • What is LIMS and how does it benefit laboratories? (basic)
  • Can you explain the process of implementing a LIMS system in a laboratory? (medium)
  • How do you ensure data security and confidentiality in a LIMS environment? (medium)
  • What are some common challenges faced in LIMS implementation and how do you overcome them? (medium)
  • Describe a situation where you had to troubleshoot a LIMS-related issue and how you resolved it. (advanced)
  • How do you stay updated with the latest trends and advancements in LIMS technology? (basic)
  • Can you discuss a successful LIMS project you were involved in and its outcomes? (medium)
  • What are the key factors to consider when selecting a LIMS vendor for an organization? (medium)
  • How do you handle data migration and integration in a LIMS system? (medium)
  • Explain the importance of validation and verification in LIMS implementation. (basic)
  • Discuss the role of LIMS in ensuring regulatory compliance in a laboratory setting. (medium)
  • How do you prioritize tasks and manage timelines in a LIMS project? (basic)
  • Can you elaborate on your experience with user training and support in a LIMS environment? (medium)
  • What are the key components of a LIMS system and their functions? (medium)
  • Describe a scenario where you had to customize a LIMS system to meet specific requirements. (advanced)
  • How do you ensure data accuracy and integrity in a LIMS database? (medium)
  • What strategies would you implement to optimize the performance of a LIMS system? (medium)
  • How do you handle upgrades and maintenance of a LIMS system? (medium)
  • Discuss the role of LIMS in enhancing laboratory efficiency and productivity. (basic)
  • What are the best practices for data backup and disaster recovery in a LIMS environment? (medium)
  • How do you collaborate with different stakeholders such as laboratory staff, IT teams, and management in a LIMS project? (medium)
  • Can you explain the role of cloud-based LIMS systems in modern laboratories? (medium)
  • How do you ensure scalability and flexibility in a LIMS system to accommodate future growth? (medium)
  • What are the key performance indicators (KPIs) used to measure the success of a LIMS implementation? (medium)

Conclusion

As you embark on your journey to explore LIMS jobs in India, remember to equip yourself with the necessary skills and knowledge to stand out in the competitive job market. Prepare thoroughly, showcase your expertise confidently, and pursue your dream career in the dynamic field of Laboratory Information Management Systems. Good luck!

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