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2.0 - 6.0 years
2 - 7 Lacs
Ankleshwar
On-site
Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India
Posted 2 months ago
5.0 years
0 - 0 Lacs
Ongole
On-site
Job Title: Laboratory Manager Location: Ongole, Andhra Pradesh Department: Diagnostic Laboratory Services Reports To: Center Head / Regional Operations Manager Employment Type: Full-Time Job Summary: We are seeking a highly motivated and experienced Laboratory Manager to lead and oversee all laboratory operations at our diagnostic center. The Lab Manager will be responsible for managing daily workflow, ensuring quality and regulatory compliance, supervising technical staff, and driving operational efficiency. This role is crucial to maintaining our high standards of patient care, accurate diagnostics, and timely reporting. Key Responsibilities:1. Operations & Workflow Management Oversee daily operations of pathology, biochemistry, hematology, microbiology, Ensure timely sample collection, processing, testing, and report delivery as per TAT (Turnaround Time) guidelines. Monitor and optimize lab workflows to improve efficiency and reduce errors. 2. Staff Supervision and Development Supervise a team of lab technicians, phlebotomists, and quality personnel. Conduct training, orientation, and competency assessments. Manage duty rosters, leave schedules, and workforce planning. 3. Quality Assurance and Regulatory Compliance Ensure compliance with NABL, NABH, CAP, and other relevant standards. Oversee implementation of quality control measures and participate in internal/external quality audits. Maintain and update SOPs, logs, and documentation per regulatory requirements. 4. Equipment and Inventory Management Oversee preventive maintenance, calibration, and validation of laboratory instruments. Coordinate with vendors and service providers for equipment servicing. Manage procurement and inventory of reagents, consumables, and lab supplies to prevent stockouts. 5. Data Management and Reporting Ensure accurate and timely data entry and reporting using LIMS or manual systems. Analyze lab performance data (e.g., sample volumes, error rates) and prepare periodic reports for management. Ensure patient confidentiality and data security at all stages. 6. Safety and Waste Management Ensure safe handling of samples, reagents, and hazardous materials. Oversee biomedical waste management practices as per statutory norms. Conduct safety drills, training, and audits regularly. 7. Customer and Stakeholder Coordination Act as a point of contact for clinicians, customer service teams, and patients for lab-related queries. Address patient concerns, complaints, or delays with empathy and professionalism. Required Qualifications: Bachelor's or Master’s degree in Medical Laboratory Technology (BMLT/MMLT), Microbiology, Biochemistry, or related field. Minimum 5 years of experience in a clinical diagnostic lab, with at least 2 years in a supervisory or managerial role. Strong understanding of diagnostic techniques and laboratory operations. Preferred Qualifications: Certification in NABL or internal auditing will be an advantage. Experience using Laboratory Information Management Systems (LIMS). Familiarity with automated analyzers and lab equipment from brands like Siemens, Beckman Coulter, Roche, etc. Key Competencies: Leadership and team management Decision-making and problem-solving Attention to detail and accuracy Effective communication (verbal and written) Adaptability to fast-paced environments Benefits: Competitive salary and incentives Health insurance Opportunities for training and career advancement A positive and professional working environment Job Types: Full-time, Permanent Pay: ₹14,446.65 - ₹62,169.34 per month Benefits: Health insurance Leave encashment Provident Fund Schedule: Rotational shift Supplemental Pay: Commission pay Overtime pay Performance bonus Shift allowance Work Location: In person
Posted 2 months ago
4.0 - 7.0 years
0 Lacs
Trivandrum, Kerala, India
On-site
Role Description Job Title: Dev III – LIMS Associate Engineer Experience Required: 4 to 7 years Qualification: Bachelor's or Postgraduate degree (BSc, BPharm, BCA, MCA, MSc, or equivalent) Location: [Add location if applicable] Job Summary We are seeking a skilled and proactive LIMS Associate Engineer with 2–5 years of experience, preferably with a strong background in Thermo Fisher’s SampleManager LIMS . The ideal candidate should have solid technical skills and hands-on experience in LIMS development, configuration, and implementation. Prior exposure to pharmaceutical laboratory processes and instrument interfacing is essential. Key Responsibilities Develop and configure SampleManager LIMS modules, including: Sample workflows Stock and instrument modules Instrument interfacing using Integration Manager Report Designer, Forms Designer, Label Designer Sample Scheduler, Batch and Lot Management Plate Handling, Stability, SQC, SM-IDI, PIMS, and Dashboards Participate in at least one or two LIMS implementation or development projects. Handle instrument interfaces, calibration, and maintenance requirements. Write and optimize SQL queries for database-related tasks. Develop and design reports, forms, and custom interfaces. Conduct thorough testing, documentation, and validation of developed solutions. Collaborate closely with QA, IT, and lab personnel to gather requirements and ensure solution alignment. Understand and follow ITIL-based support processes. Take ownership of technical challenges and resolve issues proactively. Required Skills & Experience Strong working knowledge of SampleManager LIMS and its core modules. Experience with instrument interfacing and lab equipment calibration/maintenance. Proficiency in SQL and experience working with databases. Hands-on experience in LIMS configuration and development. Familiarity with pharmaceutical lab practices and regulatory compliance. Good understanding of report and form design in LIMS. Exposure to ITIL processes and support lifecycle management. Strong documentation, testing, and validation practice adherence. Ability to work independently and take on challenges with a solution-oriented mindset. Preferred Qualifications Certification or formal training in LIMS platforms. Prior experience with stability studies, batch and lot management. Exposure to integration tools or scripting for instrument interfacing. Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less
Posted 2 months ago
2.0 years
0 Lacs
Ankleshwar, Gujarat, India
On-site
Job Description JOB TITLE Executive-I, Quality Control, Chemistry Country India Site / Unit Chemistry Ankleshwar Job Family / Sub Job Family Quality Operations Standard job Quality Control Job Purpose Generic To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to QO and regulatory requirements. All above activity shall be done living Group’s Values and Code of Ethics. Specific additions (if needed) N/A Key Accountabilities Analysis and approval Supporting in-process control sample testing by online analysis to support production activities in all 3 shifts Sampling, analysis and ascertaining quality of water, intermediates, In-process samples and API for Chemistry Ankleshwar. Testing of the method validation samples and process validation samples and cleaning validation. Perform analysis and documentation of API finished product stability study as per stability study protocol. Coordinating with Production, CWH and QA for Approval / Rejection of raw materials/finished product. Validation and verification of analytical procedures as per requirement. Reporting OOS / OOT results and deviations. Maintaining retained samples as per standard procedure. Assisting in investigation of customer complaint. Testing of new samples (Vendor approval) Give required suggestion for corrective actions and to plan effective preventive actions for the up gradation of the quality system. To ensure proper maintenance of the stability samples and their management. Disposal of waste according to the approved procedures. Continual reduction in the waste generation and effluent management. Co-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities. Documentation Generation, managing and archiving Documents including raw data, reports, COA etc as per requirements. Preparation and implementation of the SOPs in the laboratories system. Specification preparation and implementing for API raw material and API finished product according to requirement Maintaining LIMS data entries Providing technical support in compiling Annual Product Review. Analytical method development when required. 2.6.Executing on line documentation Laboratory Management Qualification and Validation of instruments/equipment Appropriate training and guidance to the subordinates. Safety in the laboratory. Regular housekeeping and upkeep of the work area. Maintaining adequate inventory of chemicals and reference standards. Adapting relevant technologies and systems in Quality control. Laboratory equipment calibration and their maintenance. Developing training modules for improvement / training for HSE and Quality systems Generate up gradation plans as need basis. Any other activity assigned by the In charge, Quality control Quality, HSE and Compliance Adhere to current GMP guidelines Following ALCOA+++ practices during documentation and related activities Compliance to local and international HSE norms Regulatory compliance ISO 14000 related activities Regular Pharmacopoeia and regulatory requirement review for compliance To participate in any regulatory/Customer inspection takes place at the site Training of self and subordinates on quality and HSE systems Team member Member of validation team. Member of Analytical transfer team. Participating in discussions and giving feedback to Manager, Quality control regarding on-going activities. Other Projects Trouble shooting activities. Participation in Industrial Excellence projects. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations Plant round in absence of QA and during IInd and IIIrd shift. Online checking of critical process parameters during round. Requirements Education / Experience M.Sc. Analytical/Organic Chemistry/Inorganic Chemistry Min. 2 years’ Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment Technical Skills & Competencies / Language Technical competence Leadership skills Analytical ability Planning ability Communication skills Problem solving Team Building Behavioural Competencies (LEAD And Others) Leveraging group values ‘Accountability, Authenticity, Collaboration, Courage and Trust’ during day to day operations Show more Show less
Posted 2 months ago
2.0 - 4.0 years
2 - 4 Lacs
Hyderabad / Secunderabad, Telangana, Telangana, India
On-site
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. 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 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 documentation, 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. Basic Qualifications Bachelor's degree with 0 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics, or a related field. OR Diploma with 4 - 7 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics, or a 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.
Posted 2 months ago
5.0 - 2.0 years
0 Lacs
Ongole, Andhra Pradesh
On-site
Job Title: Laboratory Manager Location: Ongole, Andhra Pradesh Department: Diagnostic Laboratory Services Reports To: Center Head / Regional Operations Manager Employment Type: Full-Time Job Summary: We are seeking a highly motivated and experienced Laboratory Manager to lead and oversee all laboratory operations at our diagnostic center. The Lab Manager will be responsible for managing daily workflow, ensuring quality and regulatory compliance, supervising technical staff, and driving operational efficiency. This role is crucial to maintaining our high standards of patient care, accurate diagnostics, and timely reporting. Key Responsibilities:1. Operations & Workflow Management Oversee daily operations of pathology, biochemistry, hematology, microbiology, Ensure timely sample collection, processing, testing, and report delivery as per TAT (Turnaround Time) guidelines. Monitor and optimize lab workflows to improve efficiency and reduce errors. 2. Staff Supervision and Development Supervise a team of lab technicians, phlebotomists, and quality personnel. Conduct training, orientation, and competency assessments. Manage duty rosters, leave schedules, and workforce planning. 3. Quality Assurance and Regulatory Compliance Ensure compliance with NABL, NABH, CAP, and other relevant standards. Oversee implementation of quality control measures and participate in internal/external quality audits. Maintain and update SOPs, logs, and documentation per regulatory requirements. 4. Equipment and Inventory Management Oversee preventive maintenance, calibration, and validation of laboratory instruments. Coordinate with vendors and service providers for equipment servicing. Manage procurement and inventory of reagents, consumables, and lab supplies to prevent stockouts. 5. Data Management and Reporting Ensure accurate and timely data entry and reporting using LIMS or manual systems. Analyze lab performance data (e.g., sample volumes, error rates) and prepare periodic reports for management. Ensure patient confidentiality and data security at all stages. 6. Safety and Waste Management Ensure safe handling of samples, reagents, and hazardous materials. Oversee biomedical waste management practices as per statutory norms. Conduct safety drills, training, and audits regularly. 7. Customer and Stakeholder Coordination Act as a point of contact for clinicians, customer service teams, and patients for lab-related queries. Address patient concerns, complaints, or delays with empathy and professionalism. Required Qualifications: Bachelor's or Master’s degree in Medical Laboratory Technology (BMLT/MMLT), Microbiology, Biochemistry, or related field. Minimum 5 years of experience in a clinical diagnostic lab, with at least 2 years in a supervisory or managerial role. Strong understanding of diagnostic techniques and laboratory operations. Preferred Qualifications: Certification in NABL or internal auditing will be an advantage. Experience using Laboratory Information Management Systems (LIMS). Familiarity with automated analyzers and lab equipment from brands like Siemens, Beckman Coulter, Roche, etc. Key Competencies: Leadership and team management Decision-making and problem-solving Attention to detail and accuracy Effective communication (verbal and written) Adaptability to fast-paced environments Benefits: Competitive salary and incentives Health insurance Opportunities for training and career advancement A positive and professional working environment Job Types: Full-time, Permanent Pay: ₹14,446.65 - ₹62,169.34 per month Benefits: Health insurance Leave encashment Provident Fund Schedule: Rotational shift Supplemental Pay: Commission pay Overtime pay Performance bonus Shift allowance Work Location: In person
Posted 2 months ago
2.0 - 3.0 years
2 - 3 Lacs
Thane, Navi Mumbai, Mumbai (All Areas)
Work from Office
FSSAI Approved 1.Perform chemical analysis of food samples. 2.Operate instruments like HPLC,GC-MS. 3.Ensure compliance with FSSAI, NABL & ISO standards 4.Conduct method validation 5.Preapre test reports and audit documentation 6. Supervise lab staff
Posted 2 months ago
0 years
0 Lacs
Gurgaon, Haryana, India
On-site
Job Description : R&D Tech II, Responsibilities: • Hand on exposure on Gas Chromatography, Combustion analyzer & XRF. • Collect, organize, and interpret data from instruments & enter those results into LIMS. • Interact with R&D and Pilot Plant staff to provide support, analyzing and characterizing materials for Honeywell UOP • Ability to work in shifts as per the designed schedule. • Maintain compliance with HSE policies and procedures and adopt HSE requirements for safe laboratory operations. • Communicate well with co-associates in the group and with internal customers. • Recommend and implement safety, quality, and productivity improvements. • Occasional lifting and moving of bags, samples, and other objects up to 10 pounds may be required. Show more Show less
Posted 2 months ago
0 years
0 Lacs
Mumbai, Maharashtra, India
Remote
Trending Job Description Provide remote analytical support to PPL sites, including review of analytical data and preparation of documents such as specifications, test methods, and protocols. Upload documents for review in ENSURE and initiate QMS elements in TrackWise/eDMS. Prepare and review stability protocols and reports, and perform stability data trending and analysis Responsibilities Review of analytical data generated in the analytical lab (QC/AS) including but not limited to Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner. Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc. Knowledge in analytical data review in Empower/Chromeleon/Open-Lab/Lab-Notebooks/LIMS/QMS module. Analytical Method Development and Documentation: Create and revise working test methods in compliance with compendia requirements and laboratory practices to support analytical testing. Change Request Forms (CRF) Management: Routinely initiate and manage Change Request Forms via the TrackWise system, including updates to product specifications and Certificates of Analysis (COA). Data Trending and Out-of-Trend (OOT) Analysis: Perform trend analysis of release testing data to identify OOT results. Develop, implement, and maintain procedures for trending and statistical data evaluation. External Data Review: Review analytical data generated by external laboratories to ensure compliance with specifications and quality standards. Share the review deficiencies with site team for further actions. Develop, revise, and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity. Conduct thorough Compendia reviews of USP (United States Pharmacopeia) monographs and ensure alignment with internal specifications and regulatory expectations. To participate and support site during customer audits and regulatory inspection. Lead and participate any other task assigned by HOD. Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Job Info Job Identification 8774 Posting Date 06/03/2025, 08:30 AM Apply Before 06/30/2025, 08:30 AM Degree Level Bachelor's Degree Job Schedule Full time Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN Show more Show less
Posted 2 months ago
0 years
0 Lacs
Pune, Maharashtra, India
On-site
Experience: 12+ yrs Educational Qualification: Any Degree Job Title - S&C Global Network - Strategy - MC - Industry X - Production & Operation -7 Management Level: 7-Manager Location: Bangalore, Gurgaon, Pune, Mumbai Must-have skills: SAP PPQM/ SAP EWM/ SAP PPDS Good to have skills: Ability to leverage design thinking, business process optimization, and stakeholder management skills. Job Summary: This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Provide strategic advisory services, conduct market research, and develop data-driven recommendations to enhance business performance. About Accenture Strategy & Consulting: The incumbent will be a part of the Accenture – Strategy & Consulting with Capability network in various capacities as an intern. Groups will be assigned based on assessment on the day of final hiring. The selected candidate will be aligned to one of the various Industry groups and functional areas that Accenture Strategy & Consulting operates out in. About Accenture Industry X: We help companies keep pace with change leveraging our key strengths - resilience, relevance and responsible business. At Capability Network, part of the Strategy & Consulting practice, we create 360° value and empower organizations to be ready for whatever the future holds. Through Industry X, we embed intelligence with an eye on the future of products, platform development, manufacturing and operations. Harnessing our domain expertise and the power of AI-led insights, you will work on some of the most exciting game-changing projects for global companies. Join us to reimagine digital marketplaces as you cultivate brand loyalty, create innovative customer journeys and ignite new market growth for manufacturers. As a part of this high-impact Production & Operations team within Industry X, we are looking for trailblazers, creative thinkers and problem solvers who believe in making the world a better place. We offer a vibrant career and community where you can help curate and drive global manufacturers accelerate their digital transformation journey through the following: Accelerate digital transformation journey and deploy digital manufacturing vision for our clients to deliver value through AI-led solutions, innovative experiences and smarter go-to-market strategy. Reimagine digital manufacturing with the power of AI-led insights Enabling Business from being good to being great Leverage intelligence to drive greater insights, as well as personalize experiences and optimize performance within and across marketplaces Professional & Technical Skills: Relevant experience in the required domain. Strong analytical, problem-solving, and communication skills. Ability to work in a fast-paced, dynamic environment. Has played roles like workstream lead, Solution Architect for Manufacturing work areas. Experience in scoping, designing, configuring SAP modules, and implementing it in projects. Knowledge of SAP modules integration with third-party tools (MES/ LIMS/Track & Trace etc.). At least 4-5 full cycle implementations experience in any of the modules (ECC or S/4HANA) Cross module integration knowledge Should have experience writing functional specifications and testing new functionalities. Experience in delivering technology guidance, proof of concepts, performed enterprise portfolio assessments, industry best practices reviews and technology leadership workshops. Experience in providing User trainings and conducting workshops for business. Certifications such as SAP ECC /S4 Hana certificates for respective modules will be an added advantage. Good to have certifications such as Lean Six Sigma Black Belt, APICS CSCP, IOT Platform, Advanced analytics, Agile certification (CSPO or CSM) will be an added advantage. Good to have knowledge of IOT Platforms like Microsoft Azure, AWS, SAP Leonardo, PTC etc. is a plus. Demonstrate sustained client relations management experience at a C-suite level or operated at a senior management level in the industry role Experienced in managing large teams, multi-stakeholder environments and complex digital projects engagements with a preferred global exposure Be adept at collaborating in a multi-stakeholder environment handling complex digital projects engagements, preferably in a global network Leadership skills along with strong communication, problem solving, organizational and delegation skills to nurture and inspire team members Key Competencies Day in a Life: Project Delivery: Leading/working closely with business and client stakeholders to understand client pain points, diagnose problem areas, design SAP based solutions, and facilitate deployment Responsible for SAP support to plan the activities of configuration, configure the product as per the design, conduct conference room pilots, and assist in resolving any queries related to requirements and solution design Work with cross fucntional teams to desgin the integrated solutions, identify gaps against the standard SAP functionalities and bridge those gaps by guiding technical teams to have the performance agnostic RICEFWs developed Sales & Business Development: Responsible for developing new SAP S4 Hana business, driving sales by participating and leading end to end sales origination to conversion process Experience in owning & driving responses to SAP Requests for Proposals (RFPs), Requests for Information (RFIs) Knowledge & experience in leading S/4HANA transformation proposals & projects Practice Development: Reimagine, build, and transform client business and operations by developing cutting edge assets, tool and methodologies, development of PoVs, research, white papers, support development of Go-to-market offerings. People Development: Manage and mentor talented teams of consultants and technologists supporting, providing input and guidance into the talent strategy and actively participate in engagement, capability development activities Technical Attributes: Following Module knowledge is required along with it’s cross module integrations. SAP PP PP- Production Planning: Worked on Bill of Material (BOM)/recipe management, PP Work Centre, Routing, rescheduling, MRP and MPS parameters. MRP controllers, MRP groups, Configured Production Order Types, Confirmations, Operations, Status Profile, and Selection Profile, Defining print control, Order costing, and Production order type Dependent Parameters. REM profile, planning table, reduction strategies, back flushing Should have deep knowledge in supply chain planning processes. DDMRP knowledge is good to have. Experience in requirements gathering, User Story creation and grooming, blueprint preparation, system configuration, testing, cutover, Go-live and operations for PP. Experience with Shop Floor control, MRP, VC routing, POs/STOs set-up, Batch Management & Handling Unit Management and Quality Management. Experience with dealing with key integration areas in Procurement, Supply Chain, Warehouse Management and Quality. Strong knowledge in setting up various kind of planning processes (Make to Stock, MTO, ETO, CTO) and integration with other planning solution i.e., IBP, APO & third-party planning solutions. Deep experience in various planning strategies MES: working experience on integration between MES and SAP. Worked on fixing failure of IDOCS due to master data issues or over consumption issues. Solving issues related to stock transfer IDOCS. PPDS Experience in requirements gathering, User Story creation and grooming, blueprint preparation, system configuration, testing, cutover, Go-live and operations for PPDS processes. Experience with SAP Production Planning processes and PPDS (Production Planning & Demand Scheduling) Knowledge of PPDS master data, integration models, Heuristics configurations, planning procedures, detailed scheduling board setup and usage, data transfers mechanisms for transactional data, planning runs Experience in detailed scheduling, alert monitors Knowledge in PPDS Optimizer & characteristics dependent planning will be a big plus. Deep knowledge of SAP ECC PPDS /APO, Shelf-Life Planning, Safety Stock Planning, and MRP Live functions, Sales and Operational Planning, Contract Manufacturing business processes SAP QM Should have knowledge on QM Configurations, QM Master data, different inspection types, QM Certificates, QM business processes, QM Notifications, Batch Management etc. Should understand integration between QM and other SAP modules such as PP, MM, SD, FI for inbound inspection, in-process inspection, final inspection, recurring inspections, outbound logistics etc. Strong experience in configuring Release Procedure for all purchasing documents. Good exposure in configuring business scenario like subcontract and Stock Transport Order (STO), Third Party Scenario Customer Consignment, Vendor Consignment. Integration Knowledge with MM-PP, MM-SD, MM-QM &MM-FI, MM-WM. Additional Information: Opportunity to work on innovative projects. Career growth and leadership exposure. About Our Company | Accenture Experience: 12+ yrs Educational Qualification: Any Degree Show more Show less
Posted 2 months ago
7.0 years
0 Lacs
Delhi
On-site
Overview: Jhpiego is a non-profit global health leader and Johns Hopkins University affiliate that is saving lives, improving health and transforming futures. We partner with governments, health experts and local communities to build the skills and systems that guarantee a healthier future for women and families. Through our partnerships, we are revolutionizing health care for the world’s most disadvantaged and vulnerable people. In India, Jhpiego works across various states in close collaboration with national and state governments, providing technical assistance in the areas of family planning, maternal and child health, strengthening human resources for health, and non-communicable diseases. These programs are funded by USAID, Bill & Melinda Gates Foundation, David & Lucile Packard Foundation, Children’s Investment Fund Foundation (CIFF), MSD for Mothers and other anonymous donors Jhpiego intends to respond to the urgency and magnitude of the second wave of COVID-19 in India while identifying areas and modalities of implementation aligning it to the country and state’s response to the surge. Jhpiego is hiring for the position of National Program Officer – Laboratory Systems based at New Delhi for its RISE project. The position will work closely with the India country office and state office teams for strengthening of lab capacity. The position will report to the Associate Director. Responsibilities: Lead national-level planning, budgeting, and project management for laboratory systems strengthening under the RISE project. Develop—and continuously refine—national strategies and roadmaps for laboratory capacity enhancement, aligning with government priorities. Serve as the principal liaison for laboratory systems between Jhpiego, the Ministry of Health & Family Welfare, Department of Animal Husbandry and Dairying, state health departments, and other stakeholders, fostering collaboration and ensuring alignment of objectives. Implement comprehensive gap assessments of laboratory infrastructure, workflows, biosafety, and biosecurity systems; drive targeted improvements through infrastructure upgrades, equipment deployment, and optimized SOPs. Champion the introduction and scale-up of advanced diagnostic modalities, including metagenomic (NGS) and other molecular techniques, to enhance pathogen identification and genomic surveillance. Establish a rigorous quality management system—encompassing proficiency testing, audits, and corrective action plans—to sustain high standards in diagnostic accuracy and biosafety compliance. Design and lead national-level training programs for laboratory personnel on pathogen-specific diagnostics, data management, biosafety, and laboratory leadership skills. Mentor state-level laboratory teams and focal points, building their capacity to manage laboratories independently and to train others. Document and disseminate best practices, guidelines, and policy briefs on laboratory strengthening, facilitating knowledge exchange among government partners and technical stakeholders. Architect and oversee the roll-out of a robust national laboratory network, including sample referral pathways and electronic data management platforms that support real-time reporting and analysis. Collaborate with digital health teams to optimize laboratory information management systems (LIMS) integration with national health surveillance databases. Analyze laboratory performance metrics and surveillance data to inform strategic decision-making and to produce high-quality reports for donors and government counterparts. Cultivate and manage strategic partnerships with international agencies, NGOs, academic institutions, and private sector stakeholders to leverage resources and technical expertise. Represent Jhpiego at national and international forums, advocating for investments in laboratory systems and shaping policy dialogues around diagnostic preparedness. Identify and pursue new funding opportunities, contributing to proposal development and budget design. Required Qualifications: Abilities/Skills: Familiarity with Biosafety norms, Quality management systems and laboratory information management systems Ability to work independently and as part of a team in a fast-paced environment. Experience working with government agencies, international organizations, and NGOs. Ability to analyse data and produce documents and reports of professional quality and coordinate activities independently. Fluency in spoken and written English and Hindi required. Computer skills demonstrating competency in MS Office Suite Ability to handle a variety of assignments under pressure of deadlines Ability to multitask and work in a multi-cultural team. Ability to develop productive working relationships with other team members, agencies, stakeholders and other organizations. Excellent communication, interpersonal, and organizational skills. Ability to travel up to 30% of the time. Qualifications/Knowledge and Experience: MD/PhD in microbiology/pathology. At least 7 years’ experience in implementing Lab programs Experience in HIV/TB/PM ABHIM is desirable Experience with next-generation sequencing/metagenomics applications in pathogen surveillance is desirable. Experience in capacity building e.g. developing content, planning, and facilitating training and providing technical assistance. Familiarity with the Indian public health system, newer initiatives in health sector and relevant government policies/ strategies particularly National Health Mission, and Ayushman Bharat. Jhpiego is an equal opportunity employer and offers highly dynamic and enabling work environment. Jhpiego offers competitive salaries and a comprehensive employee benefits package. Women candidates are encouraged to apply. Due to high volume of applications, only shortlisted applicants will receive a response from Jhpiego HR. RECRUITMENT SCAMS & FRAUD WARNING Jhpiego has become aware of scams involving false job offers. Please be advised: Recruiters will never ask for a fee during any stage of the recruitment process. All active jobs are advertised directly on our careers page. Official Jhpiego emails will always arrive from a @Jhpiego.org email address. Please report any suspicious communications to Info@jhpiego.org
Posted 2 months ago
0 years
0 Lacs
Hosūr
On-site
Only Male Candidate Location - Hosur Job Responsibilities: Operational Management Oversee the daily operations of the diagnostic center, ensuring smooth workflow across all departments (e.g., lab, radiology, reception, billing). 2. Staff Management and Development Recruit, train, and manage staff, including lab technicians, medical assistants, customer service representatives, and other operational staff. Develop and implement training programs to ensure staff stay updated with the latest medical technologies and protocols. Conduct regular performance reviews, motivate staff, and resolve any employee issues or conflicts. Ensure that staff adhere to health and safety standards, quality control measures, and customer service protocols. 3. Quality Assurance and Compliance Maintain and oversee compliance with all healthcare regulations and legal requirements (e.g., HIPAA, lab accreditation standards). Monitor the quality of services and diagnostic results, implementing corrective actions if necessary. Ensure the diagnostic center maintains its certifications, licenses, and accreditations. Ensure patient confidentiality and privacy are maintained at all times. 4. Financial Management Oversee budgeting and financial performance, ensuring the diagnostic center operates within its allocated budget. Manage billing processes, ensuring accurate and timely processing of patient payments and insurance claims. Monitor and control costs, identify cost-saving opportunities, and ensure financial goals are met. Analyze financial reports to identify trends and areas for improvement. 5. Patient Care and Customer Service Ensure high standards of patient care, providing a positive and professional experience for patients. Address patient concerns, complaints, and inquiries in a timely and professional manner. Work with the marketing team to develop strategies to increase patient retention and attract new clients. Ensure efficient patient flow within the center, from check-in to test completion. 6. Inventory and Equipment Management Oversee the procurement and maintenance of diagnostic equipment, ensuring they are properly calibrated and functioning. Manage the inventory of medical supplies and ensure they are stocked and available when needed. Coordinate maintenance schedules for diagnostic equipment, ensuring minimal downtime. Implement systems for tracking and ordering necessary supplies. 7. Strategic Planning and Reporting Contribute to the development of strategic goals for the diagnostic center’s growth, expansion, and service offerings. Develop and track key performance indicators (KPIs) to measure the effectiveness and efficiency of operations. Prepare and present regular reports on operational performance, financial status, patient satisfaction, and other relevant metrics to senior management or stakeholders. Identify opportunities for service innovation or expansion to stay competitive in the healthcare market. 8. Health and Safety Management Ensure that the center adheres to health and safety regulations, both for employees and patients. Implement safety protocols, including the proper handling and disposal of medical waste. Conduct regular safety drills and ensure staff are trained on emergency procedures. 9. Technology Integration Oversee the use and integration of health IT systems, including patient records (EHR), laboratory information management systems (LIMS), and other diagnostic tools. Implement new technologies that improve the accuracy, speed, and reliability of diagnostic testing. Ensure the proper training and usage of these technologies by staff. 10. Stakeholder Management Build and maintain relationships with healthcare providers, insurance companies, suppliers, and other external partners. Engage with external stakeholders to explore business development opportunities or partnerships. 11. Emergency Response Management Develop and maintain emergency response plans for situations such as power outages, equipment failures, or natural disasters. Ensure staff are trained to handle emergencies and that all safety protocols are followed. Key Skills and Qualities: Leadership : Ability to lead a diverse team and motivate staff. Problem-solving : Quick thinking to address operational challenges. Communication : Strong verbal and written communication skills to interact with staff, patients, and stakeholders. Analytical Skills : Ability to interpret data and make informed decisions to improve operations. Attention to Detail : Accuracy in managing diagnostics and patient information. Knowledge of Healthcare Compliance : Familiarity with healthcare regulations and standards. Ensure compliance with healthcare regulations, medical safety standards, and ethical practices. Develop and implement standard operating procedures (SOPs) to improve operational efficiency and service quality. Coordinate with medical professionals (e.g., doctors, lab technicians, radiologists) to ensure accurate and timely diagnostic services. Job Type: Full-time Benefits: Paid sick time Provident Fund Work Location: In person
Posted 2 months ago
130.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Job Description Manager-Lab Information Management System(LIMS) Engineer - Research & Development The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology Centres focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company’s IT operating model, Tech Centres are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each Tech Centre helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centres. Role Overview The Research and Development Sciences (RaDS) value team in R&D IT brings together product management, engineering, and data science expertise to enable data and technology products and services that accelerate our scientists' ability to discover and develop innovative medicines that change the course of human health. Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation and advance the drug discovery and development pipeline. What Will You Do In This Role Development & Testing Design, code, verify, test, document, amend, and refactor moderately complex programs and scripts using LIMS Basic. Develop subroutines and functions to enhance system functionalities. Create and test integrations with external systems to ensure seamless data flow. Implement unit and integration tests to validate code quality and functionality. Configuration & Deployment Configure user roles, permissions, and workflows within the Labware LIMS. Design, verify, document, amend, and refactor complex software configurations for deployment. Contribute to the selection of software configuration methods, tools, and techniques. Support & Troubleshooting Guide support teams in troubleshooting and issue resolution related to LIMS functionalities. Monitor and report on project progress, identifying and addressing issues as they arise. Propose practical solutions to resolve software development challenges. Collaboration & Communication Collaborate with cross-functional teams, including Application Management Services (AMS) and Quality Assurance (QA), to ensure alignment on project goals. Participate in reviews of own work and lead reviews of colleagues' work to maintain high standards of quality. Provide training and support to end-users to maximize the effective use of the LIMS. What Should You Have Bachelors’ degree in Information Technology, Computer Science or any Technology stream. 3 + Years Proficiency in LIMS Basic programming and experience with software development best practices. Proficiency in SQL and database design. Proficiency in design, modification, and optimization of Crystal Reports. Strong understanding of laboratory processes and data management. Excellent problem-solving skills and the ability to propose practical solutions. Strong communication and collaboration skills, with the ability to work effectively in a team environment. Preferred Qualifications Experience with integrations between LIMS and other laboratory systems (e.g., ERP, ELN). Knowledge of regulatory compliance standards in laboratory environments. Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Data Engineering, Data Visualization, Design Applications, Laboratory Information Management System (LIMS), Laboratory Information Systems (LIS), LabWare LIMS, Software Configurations, Software Development, Software Development Life Cycle (SDLC), Solution Architecture, SQL*LIMS, System Designs, Systems Integration, Testing Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R346605 Show more Show less
Posted 2 months ago
0 years
0 Lacs
Trivandrum, Kerala, India
On-site
Role Description Job Description We are seeking a Technical Lead with strong hands-on experience in SampleManager LIMS . The ideal candidate will be responsible for leading development tasks, coordinating with clients and teams, and ensuring timely and high-quality delivery of LIMS projects. Candidates should have strong technical and domain expertise across Pharma and Oil & Gas industries, as well as a solid understanding of system integration, validation, and regulatory requirements. Key Responsibilities Lead and execute development and configuration activities in SampleManager LIMS, including: Sample workflows Stock and instrument modules Instrument interfacing using Integration Manager Report, Forms, and Label Designer Sample Scheduler, Batch Management, Lot Management Plate Handling, Stability, SQC, SM-IDI, PIMS, and Dashboards Work independently on end-to-end implementations, upgrades, and development projects. Coordinate effectively with clients and internal teams to gather requirements, plan deliverables, and track progress. Provide technical guidance and mentorship to junior team members. Ensure code quality, manage testing cycles, deployment processes, and patch preparation. Manage support, incident resolution, and enhancements using ITIL processes and change management practices. Collaborate with QA and validation teams to ensure compliance with GxP and regulatory guidelines. Participate in systems analysis, design, development, and integration activities. Essential Skills & Qualifications In-depth knowledge of SampleManager LIMS with at least 1–2 implementation or upgrade projects. Strong technical skills in .NET, Form Designer, ETL, and reporting tools. Sound understanding of the software development lifecycle, including testing, deployment, and validation. Knowledge of ITIL frameworks, support models, and change management processes. Proven experience in client coordination and project delivery in regulated industries. Good domain knowledge in Pharma and Oil & Gas lab environments. Strong attention to detail with the ability to balance and prioritize multiple projects. Excellent written and verbal communication skills. Preferred Skills Experience working on LIMS upgrades and migrations. Familiarity with SampleManager LIMS product architecture and customization. Understanding of compliance frameworks (21 CFR Part 11, ALCOA+, etc.). Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less
Posted 2 months ago
1.0 - 2.0 years
0 - 1 Lacs
Jaipur
Work from Office
Job Role: QC Assistant Job Location: Jaipur Education: BSC / MSC Experience: 1-2 Years About Brand: Minimalist (https://www.beminimalist.co) is a science-backed Indian skincare brand built on the core values of efficacy, transparency, and comprehensiveness. Known for its ingredient-first approach, the brand formulates high-performance skincare products using proven activities and clean formulations. The company believes in creating high-quality products using best-in-class ingredients at its own manufacturing facility. Minimalist empowers consumers with knowledgeclearly stating what goes into each product and whyso they can make informed choices. With a commitment to 'Hide Nothing,' the brand champions authenticity and honesty in skincare, creating solutions that work, without the fluff. With a robust portfolio of 60+ SKUs spanning Skincare, Haircare, and Bodycare, the brand is rapidly expanding its footprint. Focused on enhancing product availability, it is strategically deepening its penetration while strengthening both Modern Trade (MT) and General Trade (GT) channels in India. The brands global presence now extends across 15+ countries, including key markets such as the UK, USA, UAE, Malaysia, Indonesia, Germany, France & Italy. Roles and Responsibilities: Assist in the collection, labeling, and preparation of samples for analysis. Ensure proper storage and documentation of samples to maintain traceability. Perform regular cleaning and sterilization of laboratory equipment and workspaces. Dispose of waste materials following established safety protocols. Prepare reagents and solutions as per standard operating procedures (SOPs). Monitor inventory levels and assist in ordering laboratory supplies. Calibrate and maintain laboratory instruments to ensure accurate results. Maintain accurate records of all QC activities, including test results and equipment maintenance logs. Adhere to all laboratory safety guidelines and regulatory requirements. Qualifications: Bachelors degree in Microbiology, Chemistry, Biotechnology, or a related field. Minimum of 1-2 years of experience in a laboratory setting, preferably in quality control. Familiarity with laboratory equipment and basic analytical techniques. Strong organizational skills and attention to detail. Proficiency in using laboratory information management systems (LIMS) is a plus. Excellent communication skills and the ability to work collaboratively in a team environment.
Posted 2 months ago
0.0 - 6.0 years
0 Lacs
Ankleshwar, Gujarat
On-site
Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India
Posted 2 months ago
5.0 - 10.0 years
5 - 15 Lacs
Pune
Work from Office
Configure and customize LabWare LIMS to meet business needs. Lead development and implementation of LIMS projects. Build and manage custom reports Support validation, UAT, and documentation
Posted 2 months ago
2.0 - 7.0 years
3 - 8 Lacs
Hyderabad, Pune, Mumbai (All Areas)
Work from Office
Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report
Posted 2 months ago
5.0 years
6 - 8 Lacs
Hyderābād
On-site
Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About the Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e.g., LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth). Minimum Requirements: Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc. Fluent in English (oral and written).Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience: Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills: Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages : English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Posted 2 months ago
3.0 - 5.0 years
5 - 8 Lacs
Bengaluru
On-site
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. We are seeking a PLM Analyst to be part of our talented team in Bangalore. This position will be an integral part of running core operations for the Product Lifecycle of a dynamic, fast paced organization for both new product development and on market commercial operations. The person in this role is responsible for creating and submitting change control, while serving as a critical resource in the change management process from inception through end-of-life for Illumina products. Maintains product and process configurations in PLM and SAP ERP. Supports cross-functional teams on the creation of Change Requests and Change Orders and assures configuration and document changes include required information while resolving any issues that arise. Scope of Responsibility: Applies problem-solving skills to analyze scope of Change and the underlying business dataset (e.g., Items, Documents, Bill of Materials, Facilities, EH&S) Packages Change scope in the form of Change Request and Change Orders – in the most efficient manner, in order to bring efficiencies to scale Prioritizes processing Changes in full alignment with the defined Service Level and expected metrics (e.g., turnaround time and quality service level) Performs thorough data analysis in light of the Change scope, in order to achieve higher accuracy level of impacted items. Scope includes, but not limited to Item and Document search – by key attributes, and descriptions both within PLM and PLM ecosystem e.g., SAP, Camstar, LIMS etc. Verifies accuracy and completeness of Changes packages by other Change Originators – where necessary, in full conformance with the underlying procedures, work instructions or job aids. Performs data quality review while processing Change workflows. Review risk towards data integrity, check for data completeness and accuracy while advancing PLM workflows through lifecycle stages Experience Required: 3-5 years of prior professional experience in the PLM space of a MedTech company with working knowledge of Enterprise Change Management, Master Data Management and Enterprise Document Control Well versed with basic GMP, regulatory and compliance requirements of a MedTech company e.g., 21 CFR 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records and Electronic Signatures) and 21 CFR Part 809 (In-Vitro Diagnostic Products) Prior experience of Data Stewards role processing Item and Document Master Data in a controlled setup is preferred We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
Posted 2 months ago
0 years
0 Lacs
Bengaluru East, Karnataka, India
On-site
Hands-on experience on testing tools like HP ALM, Kneat and SNOW - Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage - OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) - PAS/DCS Qualification - ISA95 High level of understanding - OT Security will be a plus. - Standalone Systems Qualifications - PAS/DCS Integrated with Manufacturing Equipment qualification. Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM. Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation. Ensure GxP Computerized Systems are validated as per GAMP -5 requirements. Stakeholder management and good executor with required communication. Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation/Qualification o Risk management. o Handling of defects/Deviations o Investigations o CAPA Handling o Test Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide. Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Show more Show less
Posted 2 months ago
2.0 - 4.0 years
0 Lacs
India
Remote
LIMS LabVantage Developer (Senior & Principal Level) REMOTE FREELANCE Opportunity We are looking for Senior / Principal LabVantage Developer to work on a on a freelance/B2B basis on a minimum 12-month project with scope of the project continuing for more than 2 -4 years We have multiple positions from Developers / Architects so please apply to the position before you miss out on the opportunity Please find below more information regarding the ideal candidate for this position: Your role As a Senior Consultant, you are an expert at contributing to different phases of the consulting lifecycle. You will be intensely involved in; you will define the problem, propose and refine the solution. You will also play an important role in the development, configuration and deployment of the overall solution. You will guide teams on project processes, deliverables and contribute to the proposal development, client training and internal capability-building and help detail the project scope. You will have the opportunity to shape value-adding consulting solutions that enable our client to meet the changing needs of the global landscape. Required Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. At least 5 years of experience in LabVantage LIMS implementation, enhancements and support work. Knowledge of LabVantage 8.6 or higher Knowledge of Oracle, SQL, Core Java, Java Script Preferred At least 5 years of experience in creating requirement specifications based on Architecture/Design/Detailing of Functionality and Processes At least 5 years of experience in Pharma, R&D, Healthcare domain with implementation experience of LabVantage LIMS. At least 5 years of experience in creating requirement specifications based on Architecture Or Design Or Detailing of Functionality and Processes /Development/ Configuration/solutions evaluation/ Validation and deployment At least 3 years of experience in capturing requirements related to configuration and customization, documentation, data migration analysis and mapping current business process. Integration and Interfaces with other systems or applications like ERP, PLM/other applications Experience in Software development lifecycle, database (Oracle and SQL Server) concepts and integration design. Experience in Master Data Setup and Data Migration (master and legacy data) Experience in Jasper Reports and Bartender Labels Experience in Instrument Integrations using SDMS Experience in working with geographically distributed teams. Planning and Co-ordination skills Personal Besides the professional qualifications of the candidates, we place great importance in addition to various forms personality profile. These include: High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Excellent verbal and written communication skills If this position is something of interest, please apply and share your availability to speak over LinkedIn and I will call you shortly afterLIMS LabVantage Developer (Senior & Principal Level) REMOTE FREELANCE Opportunity We are looking for Senior / Principal LabVantage Developer to work on a on a freelance/B2B basis on a minimum 12-month project with scope of the project continuing for more than 2 -4 years We have multiple positions from Developers / Architects so please apply to the position before you miss out on the opportunity Please find below more information regarding the ideal candidate for this position: Your role As a Senior Consultant, you are an expert at contributing to different phases of the consulting lifecycle. You will be intensely involved in; you will define the problem, propose and refine the solution. You will also play an important role in the development, configuration and deployment of the overall solution. You will guide teams on project processes, deliverables and contribute to the proposal development, client training and internal capability-building and help detail the project scope. You will have the opportunity to shape value-adding consulting solutions that enable our client to meet the changing needs of the global landscape. Required Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. At least 5 years of experience in LabVantage LIMS implementation, enhancements and support work. Knowledge of LabVantage 8.6 or higher Knowledge of Oracle, SQL, Core Java, Java Script Preferred At least 5 years of experience in creating requirement specifications based on Architecture/Design/Detailing of Functionality and Processes At least 5 years of experience in Pharma, R&D, Healthcare domain with implementation experience of LabVantage LIMS. At least 5 years of experience in creating requirement specifications based on Architecture Or Design Or Detailing of Functionality and Processes /Development/ Configuration/solutions evaluation/ Validation and deployment At least 3 years of experience in capturing requirements related to configuration and customization, documentation, data migration analysis and mapping current business process. Integration and Interfaces with other systems or applications like ERP, PLM/other applications Experience in Software development lifecycle, database (Oracle and SQL Server) concepts and integration design. Experience in Master Data Setup and Data Migration (master and legacy data) Experience in Jasper Reports and Bartender Labels Experience in Instrument Integrations using SDMS Experience in working with geographically distributed teams. Planning and Co-ordination skills Personal Besides the professional qualifications of the candidates, we place great importance in addition to various forms personality profile. These include: High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Excellent verbal and written communication skills If this position is something of interest, please apply and share your availability to speak over LinkedIn and I will call you shortly after Show more Show less
Posted 2 months ago
2.0 years
0 Lacs
India
Remote
LIMS Labware Developer (Senior & Principal Level) REMOTE FREELANCE Opportunity We are looking for Senior / Principal LabWare Developer to work on a on a freelance/B2B basis on a minimum 12-month project with scope of the project continuing for more than 2 -4 years We have multiple positions from Developers to Architects so please apply to the position before we you miss out on the opportunity Please find below more information regarding the ideal candidate for this position: Your role As a Senior Consultant, you are an expert at contributing to different phases of the consulting lifecycle. You will be intensely involved in; you will define the problem, propose and refine the solution. You will also play an important role in the development, configuration and deployment of the overall solution. You will guide teams on project processes, deliverables and contribute to the proposal development, client training and internal capability-building and help detail the project scope. You will have the opportunity to shape value-adding consulting solutions that enable our client to meet the changing needs of the global landscape. Required Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. At least 3+ years of experience in Labware LIMS implementation, enhancements and support work. Knowledge of Labware 6 or higher Knowledge of Oracle, SQL Preferred At least 5 years of experience in creating requirement specifications based on Architecture/Design/Detailing of Functionality and Processes At least 5 years of experience in Pharma, R&D, Healthcare domain with implementation experience of Labware LIMS. At least 5 years of experience in creating requirement specifications based on Architecture Or Design Or Detailing of Functionality and Processes /Development/ Configuration/solutions Evaluation/ Validation and deployment At least 3 years of experience in capturing requirements related to configuration and customization, documentation, data migration analysis and mapping current business processes. Integration and Interfaces with other systems or applications like ERP, PLM/other applications Experience in Software development lifecycle, database (Oracle and SQL Server) concepts and integration design. Experience in Master Data Setup and Data Migration (master and legacy data) Experience in Jasper Reports and Bartender Labels Experience in working with geographically distributed teams. Planning and Co-ordination skills Personal Besides the professional qualifications of the candidates, we place great importance in addition to various forms personality profile. These include: High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Excellent verbal and written communication skills If this position is something of interest, please apply and share your availability to speak over LinkedIn and I will call you shortly after Show more Show less
Posted 2 months ago
0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
We are a cutting-edge clinical Next-Generation Sequencing (NGS) lab based in Singapore, at the forefront of genetic research and diagnostics. Our mission is to revolutionize healthcare by providing accurate, reliable, and efficient genomic solutions at affordable prices for middle- and low-income populations. We work closely with research institutions, medical professionals, and biotech companies to advance scientific discovery and improve patient outcomes. As we continue to expand our operations, we are seeking a highly skilled and experienced Laboratory Operations & Logistics Executive to join our dynamic team. As the Operations & Logistics Executive, you will be responsible for overseeing and optimizing the logistics processes of an NGS laboratory, encompassing specimen collection through to result delivery. This role involves managing logistics efficiency, inventory management, ensuring compliance with quality standards to facilitate seamless operations. The ideal candidate should have a robust background in logistics operation and inventory management with the healthcare or biotech industry, demonstrating proficiency in managing end-to-end logistics processes and ensuring compliance with regulatory standards. RESPONSIBILITIES: 1. Pre-Testing Processes Develop and implement standard operating procedures (SOPs) for efficient biological specimen collection, handling, transportation, and receiving. Collaborate with the collection sites to ensure the integrity, proper labeling, documentation, and tracking of incoming samples. Collaborate with collection sites or healthcare facilities to streamline the pre-analytical workflows. Establish and monitor quality control measures during the pre-analytical phase to ensure accurate and reliable test results Implement and monitor protocols for sample accessioning, including data entry and verification processes 2. Post-Testing Processes Collaborate with bioinformatics teams to ensure accurate and timely result reporting. Oversee the logistics in delivery of results, ensuring secure and timely distribution to relevant stakeholders. Facilitate seamless data exchange by coordinating secure channels for sharing test results and relevant information, ensuring compliance with data protection regulations and confidentiality agreements during collaborative efforts. Develop and maintain communication channels strategies to keep internal teams informed about results delivery timelines, ensuring clear understanding of expectations, transparency, and alignment with organizational goals. Oversee the archival and retention of testing records in accordance with relevant guidelines. Collaborate with laboratory operations, and customer service, to streamline internal processes and enhance overall efficiency. 3. Logistics and Inventory Management Develop and execute logistics strategies to optimize the transportation and storage of biological samples, reagents, and consumables. Import of Biological samples: Coordinate with external shipping partners to plan and execute the timely import of biological samples, ensuring compliance with customs regulations and import restrictions. Oversee the filing and accurate completion of shipping documents, including import permits, customs declaration, and any required certifications. Coordinate with customs brokers to facilitate smooth customs clearance processes, minimizing delays and ensuring adherence to regulatory requirements. Monitor and track shipments in real-time, implementing proactive measures to address potential issues and optimize delivery timelines. Collaborate with internal teams to ensure seamless communication and coordination between logistics, laboratory operations, and sample processing teams. Implement and maintain a robust tracking system, providing visibility and accountability throughout the logistics chain. Proactively identify and address challenges related to transportation, customs clearance, or documentation, minimizing disruptions to sample processing timelines Stay informed about changes in import regulations and shipping requirements, adjusting logistics strategies accordingly to maintain compliance and efficiency. Ensure timely and secure delivery of shipments to the laboratory. Inventory (in collaboration with Laboratory Manager and QA personnel): Develop and implement comprehensive inventory management strategies for regents, consumables, and supplies, ensuring optimal stock levels to support laboratory operations. Monitor inventory levels regulatory, track usage patterns and forecast future needs. Collaborate with vendors and suppliers to establish efficient ordering processes, negotiate pricing, and maintain strong relationships to secure a reliable supply chain. Develop and maintain a system for proper storage, labeling and organization of inventory to facilitate easy retrieval and prevent errors in usage. · QUALIFICATIONS Bachelor’s degree in a relevant scientific or logistics discipline. Proven experience in laboratory operations and logistics management, preferably in a medical or biotechnology laboratory. Strong knowledge of shipping protocols and quality control processes. Familiarity with regulatory requirements and quality standards in a laboratory setting. Strong problem-solving skills with the ability to troubleshoot and resolve logistics issues. Meticulous attention to details, especially in documentation and record-keeping. Effective organizational skills to manage multiple tasks, priorities, and deadlines. Collaborative mindset with the ability to work within cross-functional teams. Willingness to stay updated on best practices related to logistics and operations. Proficient in using laboratory information management systems (LIMS) and other relevant software. Show more Show less
Posted 2 months ago
3.0 - 5.0 years
0 Lacs
Greater Bengaluru Area
On-site
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. We are seeking a PLM Analyst to be part of our talented team in Bangalore. This position will be an integral part of running core operations for the Product Lifecycle of a dynamic, fast paced organization for both new product development and on market commercial operations. The person in this role is responsible for creating and submitting change control, while serving as a critical resource in the change management process from inception through end-of-life for Illumina products. Maintains product and process configurations in PLM and SAP ERP. Supports cross-functional teams on the creation of Change Requests and Change Orders and assures configuration and document changes include required information while resolving any issues that arise. Scope Of Responsibility Applies problem-solving skills to analyze scope of Change and the underlying business dataset (e.g., Items, Documents, Bill of Materials, Facilities, EH&S) Packages Change scope in the form of Change Request and Change Orders – in the most efficient manner, in order to bring efficiencies to scale Prioritizes processing Changes in full alignment with the defined Service Level and expected metrics (e.g., turnaround time and quality service level) Performs thorough data analysis in light of the Change scope, in order to achieve higher accuracy level of impacted items. Scope includes, but not limited to Item and Document search – by key attributes, and descriptions both within PLM and PLM ecosystem e.g., SAP, Camstar, LIMS etc. Verifies accuracy and completeness of Changes packages by other Change Originators – where necessary, in full conformance with the underlying procedures, work instructions or job aids. Performs data quality review while processing Change workflows. Review risk towards data integrity, check for data completeness and accuracy while advancing PLM workflows through lifecycle stages Experience Required 3-5 years of prior professional experience in the PLM space of a MedTech company with working knowledge of Enterprise Change Management, Master Data Management and Enterprise Document Control Well versed with basic GMP, regulatory and compliance requirements of a MedTech company e.g., 21 CFR 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records and Electronic Signatures) and 21 CFR Part 809 (In-Vitro Diagnostic Products) Prior experience of Data Stewards role processing Item and Document Master Data in a controlled setup is preferred We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship. Show more Show less
Posted 2 months ago
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