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0 years
0 Lacs
Hyderabad, Telangana, India
On-site
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Posted 4 weeks ago
4.0 - 8.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Date: 30 Jun 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Designation: AQA Reviewer Job Location: Bangalore Department: Analytical Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation . At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines: Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene’ s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Job Purpose: To review the data & reports generated from GMP Laboratory (Stability) and to monitor the GMP Lab compliance. Key Responsibilities Online Sequence & Document review in HPLC, GC, KF, PXRD, ICPMS, LCMS & other all analytical instruments. (CD & FC – Intermediate, FP & Stability) Offline Raw Data review in ELN (CD & FC – IPQC, Intermediate, FP & Stability) and release of IPQC TI sheets in 24/7 Daily verification data review, PM reports and Lamp intensity report review in ELN. Compiled Report review (CD & FC – IPQC, Intermediate, FP & Stability). Calibration sequence, data review of HPLC (S17) and release of instrument. Raw material data review and release in LIMS & SAP. Reconciliation of EDMS issued prints (formats). Audit trial review of Standalone systems and chromeleon application. Monthly Date & Time verification of approximately 20 standalone instruments. Review of analytical raw data generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification. Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP. Review of Outsourced analytical report. Review of logbooks with respect to all activity performed in the lab. Responsible for taking any other job allocated by Department Head / Department In charge. Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document. Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents. Review the documents for completeness, compliance to Good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory. Ensuring of conducting regular GMP rounds at Quality Control Laboratory. Educational Qualification: M.Sc. Chemistry or Analytical or equivalent Technical/functional Skills The candidate should possess good communication, leadership and technical skills in Laboratory instruments like HPLC, GC,GCMS, LCMS, PXRD,KF etc., . He / she should have working knowledge in quality, conducting investigations and quality management systems. He / she should have experience in review of data generated from QC team of QA professional. Experience: 4 to 8 years Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Posted 4 weeks ago
0 years
4 - 5 Lacs
Baddi
On-site
Job Description Having adequate knowledge of Sampling, Testing of Raw material, Packing Material, Finish Product, Validation and Stability samples. Having adequate knowledge of Laboratory Instruments and equipment’s Calibration, Maintenance/External calibration. Having adequate knowledge of Preparation of laboratory chemicals, Reagents, test solution, and Volumetric solution. Having adequate knowledge of Reference, Chemical and Working standard management i.e., Working Standard qualification and support in working standard management. Having adequate knowledge of Data entry in SAP. Having adequate knowledge of operation and trouble shoot of HPLC/UV/IR and other QC analytical instruments and its software. Having adequate knowledge of data entry management in inventory/Information management software of QC like LIMS software. Having adequate knowledge of preparation of the QC documents like SOPs, Protocols and general documentation. Having adequate knowledge of Pharma Industry Guidelines and Pharmacopoeias. Having exposure of regulatory audit and GDP/DI compliance. Having adequate knowledge of GLP / GMP requirements.
Posted 4 weeks ago
0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Overview THE ROLE: The Staff Application Analyst will work within Agile Systems and Operations team to provide applications, business process support and continuous process improvement related to Oracle Product Lifecycle Management. This position is responsible for business process analysis, technical solution development, implementation, training and maintenance of the Agile PLM, Oracle fusion PLM Cloud, and related systems and applications. The Staff Application Analyst will work with various business groups and users in defining, prioritizing, and executing process, application enhancements and projects. In addition, the position will play the critical role of ensuring that users have adequate clarification and support on all business functional, technical requirements and specifications related to applications. How You Would Contribute Evaluate business processes and system capabilities and develop requirements for enhancements along with business collaborators. Develop and implement sound solutions related to Agile PLM and Oracle PLM Cloud. Evaluate and implement modern technology including Agile PLM, PLM Cloud application configurations, process extensions, workflow modifications, and security. Develop Agile-application-based solutions to support various enterprise application integrations including Oracle EBS, Oracle Agile for Process (Oracle P4P) Systems, LIMS (Laboratory Information System) and other related applications. Provide support to global business users to ensure the optimal performance of processes and system use. Participate in Change Management activities. Produce documentation and training on related business processes including application validation documents. Interact with Oracle Cloud Services on routine application services, issue resolutions and system upgrades. Provide daily/weekly/monthly updates to management staffs. What’s Special About The Team Agile PLM India team supports globally for production support , project development and enhancements. Team is bunch of experts with great experience and attitude. We work as a team supporting each other and believe in continuous learning. Skills SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL: Working experiences and skills with Oracle PLM Cloud, Agile 9.3.X (preferred 9.3.4) SDK/PX, J2EE technologies including Core JAVA, JSP, Servlet, JDBC, HTML, JavaScript, Groovy Scripting, XML. Linux/Unix, Weblogic, Windows servers, Web portal technologies, SQL. Good communication, interpersonal and documentation skills Business process analysis and design Excellent problem-solving skills and the ability to analyze complex business requirements. Experience Minimum 3 plus years of development experience with Agile 9.3.X (preferred 9.3.4) SDK/PX, JSP, Servlet, JDBC, HTML, JavaScript, Groovy Scripting, XML. Linux/Unix, Weblogic, Windows servers, SQL. Minimum a year of hands-on and relevant experience in Oracle Cloud PLM Product Development, Product Data Hub (PDH), Product Master Data Management, Quality Management, and Innovation Management Implementation knowlege of Oracle's Cloud PLM suite of features Experience with Oracle PLM Cloud integration capabilities such as Oracle Integration Cloud (OIC) In-depth experience with Agile PLM APIs and web services using REST and SOAP Knowledge of Oracle Product Life Cycle Analytics (OPLA), Oracle Business Intelligence Suite (OBIEE) technology platforms. Experience with supporting Agile PLM systems integration using SCMnet adaptors, Web Services, or an equivalent middleware. Good working knowledge of Agile tools like Data Load, ACP and Agile PLM Configurations for various modules including PC, PPM, PQM, PCM. Experience with product development process, data conversion and data migration. Education Bachelor’s degree in engineering, science, or information technology Preferred Qualifications Good knowledge, and skills working with business and agile users on requirements gathering, scoping analysis and solutions. Good and solid background and experiences with life sciences industry, compliances, regulatory, 21 CFR Part 11 validation processes and documentations. Certification of Oracle PLM Cloud, MDM, and PDH or equivalent experience is desired. Experienced and knowledgeable in PLM product, product functionality and related family of products Understanding of solutions, business processes, or technology designs within a product/technology family Oracle Transactional Business Intelligence (OTBI) and Business Intelligence Cloud Connector (BICC) skills Terms of Use Privacy Policy Compliance Documents CSR Policy
Posted 4 weeks ago
1.0 years
0 Lacs
Chennai
Remote
Company Overview: ElizaLIMS is a cutting-edge healthtech company building next-generation Laboratory Information Management Systems (LIMS) to streamline operations, ensure compliance, and enable smart automation in analytical, clinical, and research laboratories. We are looking for a seasoned Device Interfacing Developer with deep expertise in integrating medical and laboratory instruments with LIMS platforms. Job Overview : As a LIMS Device Interfacing Developer , you will be responsible for building, maintaining, and optimizing interfaces between laboratory instruments and our LIMS platform. You will ensure accurate and secure data capture, parsing, and transmission in compliance with industry protocols (e.g., ASTM, HL7, RS232, TCP/IP). Key Responsibilities : Design and develop device interface modules (middleware) for lab instruments using industry-standard protocols (ASTM, HL7, LIS, RS-232, TCP/IP, USB). Develop bi-directional communication to capture test orders and results between LIMS and devices. Handle instrument-specific data parsing, data validation, and error handling. Work with vendors/OEMs to understand instrument data formats, specifications, and APIs/SDKs. Implement and manage queueing mechanisms for asynchronous data transfers. Ensure robust logging, retry, and exception mechanisms for high uptime and accuracy. Collaborate with QA and domain experts to validate data mapping and clinical accuracy. Perform field installation support and remote diagnostics when needed. Maintain security and compliance with healthcare data standards (HIPAA, CAP/CLIA, GDPR). Document interface design, configuration, and maintenance procedures. Required Skills & Experience: 1+ years of experience in LIMS device interfacing/integration . 1+ years of experience in .Net development . Strong understanding of serial (RS-232), TCP/IP socket , and file-based data communication . Experience with ASTM, HL7 , or vendor-specific protocols (e.g., Roche, Siemens, Beckman Coulter, Abbott) . Familiarity with LIS middleware systems or frameworks (e.g., Data Innovations, Orchard Copia, etc.). Experience handling instrument drivers and parsing ASCII/HEX/binary data formats. Knowledge of clinical/laboratory workflows, assay mapping, and test result normalization. Hands-on experience with SQL/MySQL/PostgreSQL and structured logging. Preferred Qualifications Experience with cloud-based LIMS or SaaS platforms . Knowledge of Regulatory compliance (HIPAA, CLIA, ISO 15189, FDA 21 CFR Part 11). If you are passionate about LIMS Device Interfacing development and eager to contribute to innovative projects, we encourage you to apply. Join us in creating exceptional digital experiences! Job Types: Full-time, Part-time, Permanent, Contractual / Temporary, Freelance Application Question(s): What is your current monthly salary? What is your expected monthly salary? What is your notice period? Experience: LIMS Device Interfacing Development: 1 year (Required) Work Location: Remote
Posted 4 weeks ago
4.0 years
0 Lacs
Chennai
On-site
Line of Service Advisory Industry/Sector Not Applicable Specialism Risk Management Level Associate Job Description & Summary At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformation, co-sourcing, outsourcing and managed services, using AI and other risk technology and delivery models. IA capabilities are combined with other industry and technical expertise, in areas like cyber, forensics and compliance, to address the full spectrum of risks. This helps organisations to harness the power of IA to help the organisation protect value and navigate disruption, and obtain confidence to take risks to power growth. Why PWC At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us . At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firm’s growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations. Responsibilities · Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. · Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). · Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. · Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis) · Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. · Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. · Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR) Mandatory Skills: CSV Preferred Skills: LIMS/QMS Years of Experience: 4-8 years Education qualification: B.Tech/MBA Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required: Bachelor of Technology, Master of Business Administration Degrees/Field of Study preferred: Certifications (if blank, certifications not specified) Required Skills Creating Shared Value (CSV) Optional Skills Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Communication, Compliance Auditing, Corporate Governance, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Emotional Regulation, Empathy, Financial Accounting, Financial Audit, Financial Reporting, Financial Statement Analysis, Generally Accepted Accounting Principles (GAAP) {+ 19 more} Desired Languages (If blank, desired languages not specified) Travel Requirements Available for Work Visa Sponsorship? Government Clearance Required? Job Posting End Date
Posted 4 weeks ago
24.0 years
0 Lacs
Noida
On-site
SynapseIndia is a software development company with over 24 years of experience, featuring development offices in India and the USA. We serve clients worldwide, delivering innovative solutions tailored to their needs. Our Noida SEZ office is conveniently located just a 10-minute walk from the nearest metro station. Why work with us? Partnerships with Industry Leaders: We are a Google and Microsoft partner, staffed by certified professionals. Global Presence: As a multinational corporation, we have clients and employees across the globe. Structured Environment: We follow CMMI Level-5 compliant processes to ensure quality and efficiency. Timely Salaries: We have consistently paid salaries on time since our inception. Job Stability: Despite market fluctuations, we have not had to lay off employees. Work-Life Balance: Enjoy weekends off on the 2nd and last Saturday of every month, with no night shifts. Our employees are 100% satisfied, thanks to a culture of trust and growth opportunities. Eco-Friendly Workplace: We promote health and well-being with special anti-radiation and energy removal features in our offices. We prioritize the job security of all our employees. We celebrate all festivals with enthusiasm and joy. Yearly Appraisals: Exceptional performers can receive over 100% increments during appraisals. We recognize and reward top performers on a monthly basis for their outstanding contributions. We provide Accidental and Medical Insurance to our employees. Who are we looking for? Designation : Sr. Software Engineer (Odoo) Experience Range : 3+ years What is the work? Develop, customize, and deploy modules on the Odoo platform 16, 17, and 18. Design and implement workflows, business processes, and custom reports within Odoo. Optimize existing Odoo applications to enhance performance and user experience. Would be able to create the website under Odoo using the custom design. Collaborate with stakeholders to understand LIMS-specific requirements. Develop Odoo modules tailored to LIMS workflows, including sample tracking, testing, quality control, and inventory management. Customize Odoo modules to meet unique business needs. Configure Odoo settings, security rules, and access controls for efficient system usage. Build and implement automated workflows to streamline operations. Perform data migrations, imports, and exports between Odoo and external systems. Maintain data integrity and ensure compliance with industry standards, particularly in laboratory environments. Provide ongoing technical support for Odoo applications. Troubleshoot and resolve issues related to functionality, performance, and integrations. Regularly update and patch Odoo installations to leverage the latest features and improvements. Work closely with cross-functional teams, including lab managers, IT staff, and business analysts. Prepare technical documentation and provide training to end-users. Participate in team meetings to align on project timelines and deliverables. What skills and experience are we looking for? Proficiency in the Odoo version 16, 17, and 18, including module development, customization, and integration. Strong understanding of Odoo’s ORM framework, Python, and QWeb templates. Experience with Odoo’s core modules like Inventory, Accounting, CRM, Sales, and HR. Hands-on experience developing or integrating Laboratory Information Management Systems. Knowledge of laboratory workflows, including sample management, testing, and compliance. Familiarity with regulatory requirements in laboratory environments (e.g., ISO 17025, CLIA). Strong command of Python for Odoo development. Experience with JavaScript, XML, and HTML/CSS for front-end customization. Familiarity with PostgreSQL for database management. Experience with RESTful APIs and third-party tool integrations. Knowledge of integrating Odoo with lab instruments or ERP systems. Strong analytical and debugging skills for troubleshooting complex issues. Ability to optimize workflows and enhance system performance.
Posted 4 weeks ago
0 years
3 - 4 Lacs
Himachal Pradesh, India
On-site
🔯 Position:- Site leader - Senior Microbiologist Quality Department 🔯 Location:- Kalamb Himachal 🔯 Salary:- 50 K 🔯 Experience:- Minimum [5-6] years of working experience in plant microbiology laboratory of a pharma, cosmetic or food industry, with at least [2-3] years of experience in leading plant micro control program 🔯 Qualification:- Master Degree in Microbiology Key Responsibilities ☀️Perform microbiological testing of raw materials, water, in-process, finished products, and environmental monitoring samples in accordance with approved test methods & SOPs. ☀️Oversee routine testing for microbial contamination and maintain aseptic practices in the laboratory. ☀️Supervise, train, and mentor junior microbiologists and lab technicians on microbiological testing, SOPs pertaining to microbiological laboratory, Reporting of micro data & other microbiology related work. ☀️Ensure micro compliance with applicable regulatory standards (e.g., FDA, ISO, HACCP, cGMP, EU regulations). ☀️Supervise/lead site Cleaning & Sanitization program, Identify & execute areas of improvement ☀️Develop and validate microbiological test methods (e.g., bioburden, endotoxin, sterility, pathogen detection). ☀️Investigate deviations, out-of-specification (OOS) results, and contamination incidents; participate in root cause analysis and CAPA implementation. ☀️Maintain and calibrate laboratory equipment and ensure availability of necessary supplies. ☀️Prepare and review technical documents including SOPs, reports, and protocols. ☀️Coordinate with cross-functional teams (Production, QA, R&D, Maintenance) to resolve microbiological issues and support continuous improvement. ☀️Manage microbiological data, trend reports, and present findings to management. ☀️Participate in internal and external audits and inspections. 👉🏻 Key Attributes 🔆 Certifications (preferred): Six Sigma, Lean, ISO Lead Auditor, ASQ Certified Quality Manager (CQM), or similar. 🔆 Technical Skills: Basic knowledge of quality tools and methodologies (FMEA, SPC, Root Cause Analysis, etc.) Hand on working experience in data management tools like LIMS, DMS, ERP & MES Systems 🔆 Regulatory Knowledge : Basic knowledge of industry regulations and standards relevant to IP, BP, USP, WHO GMP guidelines 🔆 Soft Skills : Leadership, communication, problem-solving, result oriented with good interpersonal skills. Computer knowledge & proficiency in Microsoft tools like Word, Excel, Powerpoint is essential. Skills: regulatory compliance,technical documentation,training and mentoring,plant microbiology,microbiology,microbiological testing,method development and validation,plant micro control program,cleaning and sanitization,root cause analysis,food industry,,data management tools (lims, dms, erp, mes)
Posted 1 month ago
0 years
0 Lacs
Baddi, Himachal Pradesh, India
On-site
Job Description Having adequate knowledge of Sampling, Testing of Raw material, Packing Material, Finish Product, Validation and Stability samples. Having adequate knowledge of Laboratory Instruments and equipment’s Calibration, Maintenance/External calibration. Having adequate knowledge of Preparation of laboratory chemicals, Reagents, test solution, and Volumetric solution. Having adequate knowledge of Reference, Chemical and Working standard management i.e., Working Standard qualification and support in working standard management. Having adequate knowledge of Data entry in SAP. Having adequate knowledge of operation and trouble shoot of HPLC/UV/IR and other QC analytical instruments and its software. Having adequate knowledge of data entry management in inventory/Information management software of QC like LIMS software. Having adequate knowledge of preparation of the QC documents like SOPs, Protocols and general documentation. Having adequate knowledge of Pharma Industry Guidelines and Pharmacopoeias. Having exposure of regulatory audit and GDP/DI compliance. Having adequate knowledge of GLP / GMP requirements.
Posted 1 month ago
4.0 years
0 Lacs
Greater Chennai Area
On-site
Line of Service Advisory Industry/Sector Not Applicable Specialism Risk Management Level Associate Job Description & Summary At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformation, co-sourcing, outsourcing and managed services, using AI and other risk technology and delivery models. IA capabilities are combined with other industry and technical expertise, in areas like cyber, forensics and compliance, to address the full spectrum of risks. This helps organisations to harness the power of IA to help the organisation protect value and navigate disruption, and obtain confidence to take risks to power growth. Why PWC At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us. At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firm’s growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations. Responsibilities · Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. · Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). · Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. · Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis) · Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. · Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. · Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR) Mandatory Skills: CSV Preferred Skills: LIMS/QMS Years of Experience: 4-8 years Education qualification: B.Tech/MBA Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required: Bachelor of Technology, Master of Business Administration Degrees/Field of Study preferred: Certifications (if blank, certifications not specified) Required Skills Creating Shared Value (CSV) Optional Skills Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Communication, Compliance Auditing, Corporate Governance, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Emotional Regulation, Empathy, Financial Accounting, Financial Audit, Financial Reporting, Financial Statement Analysis, Generally Accepted Accounting Principles (GAAP) {+ 19 more} Desired Languages (If blank, desired languages not specified) Travel Requirements Available for Work Visa Sponsorship? Government Clearance Required? Job Posting End Date
Posted 1 month ago
0 years
2 - 6 Lacs
Hyderābād
On-site
Job title : Global stability management specialist Grade: Level 1.1 minimum Hiring Manager: Head of Report Issuance, Hyderabad Hub Location: Hyderabad % of travel expected : As per business needs Job type: Permanent About the job Our Team: Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Attach supplementary materials that support the report's content Check the report is consistent in appearance and adheres to style guidelines Evaluate and adjust user access rights to system documentation to ensure security and validity Launch and manage the review workflow in CMS Receive report approval, final reviewer agreement and initiate approval workflow in CMS/ Veeva Regularly update and maintain records of document ownership and ensure compliance with access protocols Review the report to correct any language or typographical errors About you Experience : Experience in pharmaceutical quality Soft skills : Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments Technical skills : LIMS, Word, Excel, Power Point; Experience in a Pharmaceutical GxP environment, preferred experience in stability management or activities Education : Bachelor's degree in stability science, biology, chemistry, or a related field. Advanced degree preferred Languages : Excellent English communication and writing, French or other Languages in addition preferred
Posted 1 month ago
1.0 - 31.0 years
1 - 2 Lacs
Ulwe, Panvel
On-site
Job Summary:A Phlebotomist is responsible for collecting blood and other specimens from patients for laboratory testing, ensuring proper handling, labeling, and documentation. The ideal candidate should be skilled in venipuncture, maintain patient safety and comfort, and uphold infection control protocols. Key Responsibilities:Collect blood samples via venipuncture and capillary puncture. Label and document specimens accurately. Ensure timely dispatch of samples to the lab. Verify patient identity and explain procedures to ensure comfort and cooperation. Maintain cleanliness and sterility of equipment and work areas. Follow all protocols for infection control and biosafety. Assist in conducting ECGs, audiometry, and other pre-medical tests (if trained). Maintain inventory of phlebotomy supplies. Handle sample tracking and documentation via LIMS or manual records. Participate in health camps and home collection services as required. Qualifications and Skills:Education: Diploma or Certification in Phlebotomy / DMLT or relevant lab technician course. Experience: 0–2 years (freshers can be considered with proper training). Good communication and patient-handling skills. Knowledge of basic medical terminology and lab safety standards. Familiarity with sample preservation and transport guidelines. Desirable Attributes:Compassionate and patient-centered attitude. Attention to detail and organizational skills. Ability to work under pressure and in a team environment. Willingness to travel for sample collections (if applicable).
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
Mumbai Metropolitan Region
On-site
Kenvue Is Currently Recruiting For a Scientist, R&D Analytical What We Do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role Reports To Director - Analytical Chemistry Location: Asia Pacific, India, Maharashtra, Greater Mumbai Work Location: Hybrid What You Will Do Kenvue is currently recruiting for: Scientist, R&D Analytical This position reports into Principal Scientist, R&D Analytical and is based at Mumbai, India Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role reports to: Principal Scientist, R&D Analytical Location: Mumbai Responsibilities The Scientist, R&D Analytical is responsible for performing analytical and stability testing, conducting advanced research activities and utilizing technology and programs to enable Innovation projects: Key Responsibilities Lead and manage analytical research projects in R&D department Develop, optimize, validate and transfer analytical methods to support product development and life cycle management projects Execute developmental stability testing for Drug and Cosmetic products Collaborate with cross-functional teams to drive scientific advancements Provide technical expertise in analytical instrumentation and data analysis Ensure expertise in a wide range of analytical technologies and instrumentation for testing capabilities. Execute the assigned stability testing for shelf-life assessment of stability studies. Participate in method transfer process regarding testing activities. Work on specific research projects, if required. Stay current with industry trends and technologies to drive innovation Support process owners or subject matter experts for assigned responsibilities, critical laboratory processes and quality systems. Required Qualifications What we are looking for Minimum Masters in Chemistry or equivalent science (e.g. Biochemistry, Pharmaceutical Sciences) or Ph.D with 4-8 years of proven working experience in Analytical Chemistry and/or Medicinal chemistry, Quality Control or related functions in healthcare/pharma/FMCG sector with exposure to GMP and Quality environment preferred Proven track record of leading successful scientific projects Experience working in Analytical Chemistry supporting new product development and life cycle management projects in a Consumer Health or Pharmaceutical environment Strong knowledge in UPLC, HPLC, and GC to execute Analytical test method development, validation and optimization in a cGMP environment Solid understanding of analytical and physical testing capabilities, technical skills related to instrumentation principles and working, basic troubleshooting, good documentation practices, data integrity aspects, etc. Experience working in Analytical Chemistry supporting new product development and life cycle management projects in a Consumer Health environment Excellent communication and collaboration skills Strong experience with Empower chromatography data system, using electronic laboratory notebooks (ELN), and LIMS systems. Ability to grasp technical/compliance requirements and execute assigned work to meet the key performance indicators Excellent oral and written communication and articulation skills Challenges the status quo and brings innovative ideas and suggestions Displays technical curiosity and self-initiative to deliver beyond usual activities Good interpersonal skills to partner across functions, sites, and regions If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Posted 1 month ago
0 years
0 Lacs
Vadodara, Gujarat, India
On-site
Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive - Analytical Development Date: Jul 3, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Method development, Method Validation and routine analysis in Orals and Non-orals Formulations. Area of Experience: Microbial Enumeration Test Test for specified Micro-organisms Bio-burden Test , Antimicrobial Effectiveness Test, Sterility Test , Bacterial Endotoxin Test Microbiological Assay Microbial Culture propagation, maintenance and enumeration. Growth Promotion Test Environment monitoring. Preparation of SOP's/STP's/Documentation Calibration of laboratory equipment/Instrument To work as per cGMP/GLP Compliance Exposure to LIMS Apply Now » Apply Now Start applying with LinkedIn Please wait...
Posted 1 month ago
4.0 - 9.0 years
5 - 11 Lacs
Hyderabad, Pune, Bengaluru
Hybrid
At least 3-9 years of experience in LIMS(LV/LW) Implementation /Configuration/Customization using Java, Java script. integration with Lab applications, and should have implemented at least 2-3 projects with role involving development using LabVantage platform and Jasper/iReport/Java reporting tool Interface with key stakeholders and apply your technical proficiency across different stages of the Software Development Life Cycle including Requirements Elicitation and translating to functional and/or design documentation for LabVantage LIMS solution, Application Architecture definition and Design, Development, Validation and release.
Posted 1 month ago
5.0 - 8.0 years
15 - 25 Lacs
Noida, Hyderabad, Bengaluru
Work from Office
Computer system validation Experience: 5 to 8 Years Location:- PAN India Notice period : Immediate to 15days Computer system validation regulatory and compliance support Create and implement SOPs for Computer System Validation CSV including templates for validation deliverables Conduct validation activities for software implementation ensuring compliance with regulatory standards Prepare and update SOPs for equipment instruments and analytical methods Manage incidents deviations and CAPA related Monitor calibration validations and routine laboratory operations Train team members on SOPs and validation processes Qualifications Skills Strong expertise in CSV and software validation processes Experience in incident management CAPA handling and lab compliance Knowledge of regulatory requirements
Posted 1 month ago
0 years
8 - 9 Lacs
Himachal Pradesh, India
On-site
Position:- QUALITY ASSURANCE (Site leader) Location:- Kalamb Himachal Pradesh Salary:- 8-9 LPA Experience:- Minimum [5-6] years of quality assurance experience in a manufacturing/production environment, with at least [2-3] years in a lead role Qualification:- Master Degree in Chemistry or equivalent Key Responsibilities 🔆 Lead QA Activities: Oversee all on-site quality assurance activities, ensuring compliance with company policies, industry standards, and regulatory requirements (e.g., ISO, GMP, FDA, HACCP, etc.). 🔆 Quality Systems Management: Maintain and improve the Quality Management System (QMS), including product release, non-conformance management, change Control, failure investigation & CAPA, audit readiness, and documentation control etc 🔆 Inspections & Audits: Prepare for and lead internal and external audits, including those by customers and regulatory bodies. Implement corrective actions and ensure follow-through. 🔆 Team Leadership: Supervise and mentor QA staff; manage workloads, training, and performance reviews. 🔆 Process Improvement: Work closely with production and engineering teams to identify quality issues, root causes, and implement effective corrective and preventive actions. 🔆 Reporting & Metrics: Track and report key quality metrics (KPIs), such as defect rates, customer complaints, audit scores, and non-conformance trends. 🔆 Customer Interface: Serve as the point of contact for customer quality issues, complaints, and audits. 🔆 Training & Compliance: Develop and deliver quality training programs across the site to foster a culture of quality and continuous improvement. 👉🏻 Key Attributes 🔆 Certifications (preferred): Six Sigma, Lean, ISO Lead Auditor, ASQ Certified Quality Manager (CQM), or similar. 🔆 Technical Skills: Proficiency in quality tools and methodologies (FMEA, SPC, Root Cause Analysis, etc.) Hand on working experience in data management tools like LIMS, DMS, ERP & MES Systems 🔆 Regulatory Knowledge: In-depth knowledge of industry regulations and standards relevant to IP, BP, USP, WHO GMP & ICH guidelines 🔆 Soft Skills: Strong leadership, communication, problem-solving, result oriented with excellent interpersonal skills. Skills: iso,spc,gmp,lean,root cause analysis,leadership,quality systems management,quality assurance,six sigma,iso lead auditor,asq certified quality manager,quality management system (qms),fda,iso compliance,haccp,data management tools (lims, dms, erp, mes),fmea
Posted 1 month ago
4.0 years
3 - 8 Lacs
Hyderābād
On-site
Description: To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc.). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage. Performing qualification, periodic calibration, and maintenance of laboratory instruments. Maintain proper cleanliness, calibration, and qualification status of analytical instruments. Coordinate with warehouse and QA for sampling of incoming materials as per SOPs. Ensure proper labeling, storage, and disposal of samples and reference standards. Support internal, customer, and regulatory audits by providing required documentation and clarifications. Implement corrective and preventive actions (CAPA) as per audit observations. Additional Responsibilities: Participate in method validation, verification, and transfer activities as required. Assist in updating and reviewing SOPs, specifications, and analytical procedures. Contribute to continuous improvement initiatives in the QC department. Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor. Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed. Education: B. Pharma - Required Master Degree M. Sc - Preferred Master Degree M. Pharma - Preferred Experience: 4 years or more in 4 - 6 Years Skills: Material Specifications Review - Intermediate Material Release and Compliance - Intermediate Non-Conformance Management (RM/PM) - Intermediate Sampling and Testing Procedures for RM/PM - Advanced Regulatory Compliance for RM/PM - Intermediate Sampling of Raw & Packaging Materials - Intermediate GLP Compliance & Documentation - Intermediate Documentation & Data Integrity - Intermediate CAPA, Deviation, and Change Control Management - Intermediate Specifications & Test Methods Documentation - Intermediate Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Posted 1 month ago
5.0 years
6 - 9 Lacs
Panchkula
On-site
About Vibcare Healthcare Vibcare Healthcare is a WHO-GMP certified contract manufacturer that supplies high-quality allopathic medicines across India and to export markets. Our modern plant makes tablets, capsules, liquids and topical products under strict quality standards. Role Overview The QC Manager will lead our Quality Control laboratory and ensure every raw material, in-process sample and finished product meets the required specifications and regulatory guidelines. You will manage a team of analysts, uphold cGMP practices and support regulatory audits. Key Responsibilities Lab Management : Plan and supervise daily testing of raw materials, bulk and finished goods (HPLC, GC, UV, wet chemistry, microbiology). Documentation : Review and approve analytical reports, COAs, SOPs and calibration logs. GMP Compliance : Maintain data integrity, good documentation practices and readiness for WHO, FDA and customer audits. Equipment & Calibration : Ensure timely qualification, calibration and preventive maintenance of all QC instruments. Stability & Validation : Oversee stability studies and analytical method validation/verification. Team Development : Train, guide and appraise QC chemists and technicians; promote a culture of continuous improvement. Change Control & CAPA : Investigate OOS/OOT results, implement corrective actions and monitor effectiveness. Cross-Functional Support : Coordinate with Production, QA and Regulatory Affairs for timely product release and dossier requirements. Requirements Experience : Minimum 5 years in pharmaceutical QC, with 2 years in a supervisory / manager role. Education : B.Pharm / M.Pharm / M.Sc (Chemistry, Pharmaceutical Sciences or equivalent). Technical Skills : Strong hands-on knowledge of HPLC, GC, dissolution, microbiology, cGMP, GLP, ICH guidelines and data-integrity principles. Soft Skills : Good leadership, problem-solving and communication abilities; proficiency in MS Office / LIMS / ERP. Personal Traits : Detail-oriented, disciplined, able to meet deadlines and comfortable facing audits. Benefits Competitive salary + performance bonus Medical & accidental insurance for self and dependants Professional training and skill-upgradation support Subsidised meals and company transport Friendly, growth-oriented work culture
Posted 1 month ago
5.0 - 8.0 years
0 Lacs
Mehsana
On-site
Job Title: Senior Executive - Quality Control Location: Mehsana, Gujrat About [Company Name]: Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter/manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America & Europe. Apart from promoting our branded products in the retail sector, we also participate in a number of global tenders in a number of countries. The team comprises of a group of first generation marketing expats and some of the best technocrats in the field. The company has four manufacturing bases in India, manufacturing a variety of products. This job posting is in a hormone formulation manufacturing division of Celogen Pharma. Job Summary: The Senior Executive - Quality Control will be a key member of our Quality Control team, responsible for ensuring the highest standards of quality for our pharmaceutical products, from raw materials to finished goods. This role involves the execution and oversight of various analytical tests, data review, documentation, and active participation in laboratory investigations and continuous improvement initiatives. The ideal candidate will have a strong background in pharmaceutical QC, excellent analytical skills, and a thorough understanding of cGLP guidelines. Responsibilities: Analytical Testing: · Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, stability samples, and packaging materials using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, KF, Dissolution, Titration, Physical testing). · Ensure all testing is conducted in accordance with approved pharmacopoeial methods and in-house specifications. · Operate, calibrate, and maintain analytical instruments, ensuring their optimal performance and readiness for testing. Data Review & Documentation: · Thoroughly review analytical data, raw data, and laboratory notebooks for accuracy, completeness, and compliance with established procedures and regulatory requirements. · Prepare and review Certificates of Analysis (COAs) and other relevant quality documents. · Ensure timely and accurate documentation of all testing activities, results, and observations. · Maintain detailed and organized laboratory records. Investigations & Deviations: · Participate in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, identifying root causes and recommending corrective and preventive actions (CAPAs). · Document and investigate laboratory deviations, ensuring adherence to established procedures. · Support the implementation and verification of CAPAs. Method Development & Validation Support: · Assist in the development, transfer, and validation of analytical methods as per regulatory guidelines. · Conduct feasibility studies and provide technical input for method optimization. Compliance & Audits: · Ensure strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable regulatory guidelines (e.g., FDA, MHRA, WHO). · Participate in internal and external audits (e.g., regulatory inspections, customer audits) by providing necessary documentation and technical support. · Address audit observations and implement corrective actions. Training & Mentorship: · May assist in training junior QC analysts on analytical techniques, instrument operation, and laboratory procedures. · Serve as a technical resource for other team members. Safety & Housekeeping: · Comply with all laboratory safety procedures and guidelines. · Maintain a clean, organized, and safe working environment. · Manage laboratory waste in accordance with environmental regulations. Continuous Improvement: · Identify opportunities for process improvements and efficiency enhancements within the QC laboratory. · Contribute to the revision and creation of Standard Operating Procedures (SOPs) and other quality documents. Qualifications: · Education: Bachelor's or Master's degree in Pharmacy, Analytical Chemistry, Chemistry, or a related scientific discipline. · Experience: 5-8 years of progressive experience in Quality Control within a pharmaceutical manufacturing environment. Skills & Competencies: · Proficient in operating and troubleshooting a wide range of analytical instruments (HPLC, GC, UV-Vis, FTIR, KF, Dissolution apparatus, etc.). · Strong understanding of analytical method validation and transfer principles. · Experience with LIMS (Laboratory Information Management System) is highly desirable. · Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). · In-depth knowledge of cGMP, GLP, and regulatory requirements (e.g., ICH guidelines). · Excellent analytical, problem-solving, and critical thinking skills. · Strong attention to detail and accuracy. · Ability to work independently and as part of a team in a fast-paced environment. · Excellent written and verbal communication skills. · Strong organizational and time management skills. · Experience with specific pharmaceutical dosage forms (e.g., tablets, capsules, injectables, liquids). · Familiarity with Data Integrity principles. · Certification in Six Sigma or Lean Manufacturing is a plus. Job Type: Full-time Work Location: In person Expected Start Date: 15/07/2025
Posted 1 month ago
4.0 - 5.0 years
2 - 5 Lacs
Ahmedabad
On-site
Department MORAIYA QC Job posted on Jul 03, 2025 Employment type P-P7-Probationer-HO Staff Role name: QC - QMS - GLP Division - Moraiya Department - Quality Control Category - Staff Qualification - M.Sc./B.Pharma/M.Pharma Experience - 4 - 5 Years Zydus Experience - Must have completed at least two PMS cycle. Job Responsibilities: Main activities- related to Trackwise - Change control/ CAPA /NQ incident trend / Risk assessment (rarely) / IRA documents submission like, raw data/chromatogram etc. , Effective ness check of CAPA in track wise / SOP revision and Training) 1. To ensure day-to-day monitoring and compliance of the laboratory activities. 2. To ensure data integrity and good laboratory practices in the department. 3. To ensure global CAPA implementation within timeframe. / To comply the statutory compliance aspect. 4. To follow the Good Laboratory Practices. 5. To maintain interpersonal relationship and provide support to other functional group in the department. 6. To maintain data integrity and follow cGMP and GDP. 7. To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI. 8. To maintain and ensure controlled laboratory practice in the quality control department. 9. To ensure laboratory inventory management. 10. To follow the SOPs of Quality control department and related area. 11. To prepare / revise the SOP's, related to QC in software except microbiology lab. 12. To impart the training after revision of SOPs as per the requirement. 13. To perform related documentation/transaction in the software (e.g. LIMS, Zytims/Trackwise/SAP) based on assigned user privileges. 14. To assist in the Qualification / Installation of instrument equipment with suitable documentation. 15. To perform the qualification of instruments as per the requirements 16.To co-ordinate with in-house service engineers and / or external service engineers as and when required. 17. To participate and provide appropriate feedback during failure investigation (if any). 18. To review the raw data of Raw material / Finish product /stability sample/ Validation sample / Exhibit sample analysis with respect to SOP and GDP. 19.To ensure the destruction of remainant samples after analysis as per applicable procedure. 20. To ensure the usage of required PPE’s during respective activities in the laboratory. 21.To ensure up-keeping of the instrument/equipment. 22.To inform section head about any OOS/ OOC/Incident on its immediate occurrence and for day to day activities. 23.To investigate OOS/OOC/Incident (if any) under consultation with the department head/section head. 24.To keep the things and work area clean and tidy and get involved for the routine trouble shooting (if any). 25. To execute the activities with maximum output with complete documentation. 26. To provide documentation of commercial batches to IRA. 27. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy. 28. To prepare the audit response of internal/external customer/SME observation to QC. 29. To perform related documentation/transaction in the software (e.g. LIMS, SAP, Trackwise, DMS, Minitab, Zytims, Legatrix) based on assigned user privilege. 30. To initiate, track and closure of QMS event (CAPA, change control, incident, deviation, event, extensions etc, through Trackwise and in format-based system) and escalate it for completion. 31. Handling of laboratory information Management System (LIMS) system under the guidance of LIMS administrator, which includes preparation/modification/review and approval of specifications, worksheets, tests plans, stability protocols, Masters etc. as per requirement. 32. To assist Validation/Re-validation of LIMS modules as and when required. 33. To prepare validation protocol and report and co-ordinate for the validation of spread sheets as and when required. 34. Completion of Any other specific work or assignment as given by the section head/department head. 35. To report abnormalities (if any) to section head or designee. 33. To prepare Quality metrics and QI sheet, department level QRM data and to record action plan 34. To prepare trend data of QMS events. 35. To prepare analytical method verification/validation protocol/report. 36. To initiate the activity regarding New / revision of technical agreement / Quality agreement. 37. To initiate the Risk assessment / Gap assessment involving in the respective activity 38. To Make entry and verify the details in Zytimes. 39. To perform the required activities related to QUEST / SLIM programme. 40. To perform the required activities related to statutory requirements in Legatrix. 41. Management of column and other resources used in analytical activities. 42. To escalate the Issues related to the Process, Product, Quality, Cleaning process or documentation related activities to his/her immediate supervisor and take the appropriate action related to it. 43. To escalate any failures and overdue activity that can have a potential impact on product quality to his/her immediate reporting authority.
Posted 1 month ago
34.0 years
2 - 4 Lacs
Gangānagar
On-site
Business Development Executive/Sr. Executive/Asst. Manager/Manager Company Name Dr. B. Lal Clinical Laboratory Company Website Company details Dr. B. Lal Clinical Laboratory, established in 1991, has been at the forefront of providing exemplary Pathological and Diagnostic solutions. With a commitment to incorporating the finest infrastructural and technological advancements in the global health sector, we have become a distinguished preference over the past 34+ years. Our relentless passion for delivering top-quality services, coupled with the unwavering trust of doctors and patients, has positioned us as a leader in reputed pathology lab networks. Dr. B Lal Clinical Laboratory Pvt. Ltd. stands out as the only Pathology Lab Network with a remarkable presence of more than 130+ collection centers across Rajasthan. Our highly sophisticated Central Processing Laboratory, equipped with state-of-the-art technology, is complemented by ten regional laboratories strategically located in Kotputli, Bhilwara, Chittorgarh, Bikaner, Ajmer, Alwar, Sriganganagar, Jodhpur, Ahmedabad, Kota, Bharatpur, and Sikar. This expansive network enables us to provide prompt and efficient services to our valued customers. Location Jodhpur, SriGanganagar, Sikar, Alwar, Bikaner, Ahmedabad Mode of Working Work From Office Days of Working 6 Days a week Responsibilities Role Definition: The Business Development Specialist is responsible for driving growth by identifying and acquiring new customers within the zone. This role involves prospecting, customer profiling, building relationships, and promoting the organization's brand and services to achieve sales targets and market expansion goals Deliverables: 1. Market Research and Analysis 2. Customer Acquisition and Pipeline Development 3. Customer Relationship Management 4. Sales Process Management 5. Reporting and Performance Analysis Key Responsibilities: Prospecting and Customer Acquisition: 1. Conduct market research in the zone to identify industry trends, competition, potential customers, and growth opportunities. 2. Prospect potential customers from different channels - Clinicians, Corporate hospitals, SIS, Franchisee partners, Corporate Industry, etc. Reach out to a minimum of 200 new prospects each month. 3. Implement a field-level lead generation plan to build a pipeline of qualified leads. Generate at least 25 qualified leads per month. MSL Development and Management: 1. Develop and update an MSL of a minimum 150 potential customers every quarter for conversion, engagement and building brand visibility 2. Regular meeting with identified potential customers to nurture relationships and explore business opportunities. Conduct at least 10 meetings with potential customers every day. Customer Profiling and Needs Assessment: 1. Create profiling of potential customers to understand their needs, desires. Identify customer pain points and business challenges through needs assessment. 2. Segment the customer based on criteria of A, B, C, and D Customer to prioritize outreach efforts. Solution Offering: 1. Create and present the elevator pitch, tailored solutions, products and proposals that address customer needs and align with service offerings. 2. Collaborate with the Product and Centre of Excellence team to develop and manage scientific content and promotional materials for effective communication with customers. Communicate scientific literature detailing product features, benefits, and advantages to the target audience. 3. Handle objections and close deals in collaboration with Zonal Managers to ensure customer conversion. Account Management: 1. Schedule regular follow up visits with existing customers to review their needs, satisfaction levels, and any issues they may have. 2. Plan and execute business activities such as RTMs,CMEs, Product-led scientific seminars, and other community engagement based on business needs and objectives. Engage a minimum of 30% of MSL through such activities every quarter. Sales Process Management: 1. Manage the end-to-end sales process from lead generation to contract closure and post-sales follow-up. 2. Log all sales activities daily in the LIMS Sales module to track progress, update records, and analyze sales performance metrics. 3. Prepare reports and presentations on sales performance, sales funnel status, and market insights every month. Success Metrics: 1. Generate at least 25 qualified leads per month 2. Conduct a minimum of 10 meetings with potential customers daily 3. Achieve a 30% conversion rate on presented proposals 4. Achieve minimum 75% MSL productivity Role Requirements: 1. Bachelor’s degree in science or a related field. 2. Demonstrated track record of success in sales and key account management, particularly in the Healthcare sector. 3. Minimum 60% score in matriculation and higher secondary 4. Exceptional customer service skills, encompassing active listening, problem-solving, and interpersonal communication. Strong written and verbal communication skills Interview process Virtual Any other additional information Candidate Profile Looking for a rock star developer. Contributes appropriately to conversations Understands client-server architectures Flexible attitude, ability to perform under pressure A commitment to quality and a thorough approach to the work Strong English communication skills (written/oral) Ability to work in a dynamic, agile environment ATGS official Email anita@atgs.co.in ATGS SPOC Contact number 7406026370 Job Types: Full-time, Permanent Pay: ₹20,000.00 - ₹40,000.00 per month Benefits: Cell phone reimbursement Health insurance Leave encashment Paid sick time Paid time off Provident Fund Schedule: Day shift Supplemental Pay: Performance bonus Ability to commute/relocate: Sri Ganganagar, Rajasthan: Reliably commute or planning to relocate before starting work (Preferred) Experience: Medical sales: 1 year (Preferred) Location: Sri Ganganagar, Rajasthan (Preferred) Willingness to travel: 75% (Preferred) Work Location: In person
Posted 1 month ago
0 years
0 Lacs
Sanand, Gujarat, India
On-site
ABOUT AGRATAS : Agratas is a wholly owned subsidiary of Tata Sons. We design, develop and manufacture high-quality, high-performance, sustainable batteries applied to multiple use cases in the mobility and energy sectors, to match our customers’ requirements. Agratas is a scale-up business with a start-up mentality, driven by our pursuit of green growth and technological progress. We develop next-generation battery technologies at our state-of-the-art R&D Innovation Hubs in India and the UK. JOB SUMMARY Key Accountabilities and Responsibilities: 1.Infrastructure Requirements: • Take ownership of OT and IT infrastructure and network requirements for the manufacturing site. • Collaborate with Facilities and Capital Delivery/Project teams on infrastructure expansion needs, including planning, design, and execution phases for the Gigafactory setup. • Ensure that infrastructure and network designs align with operational needs and manufacturing technology requirements. 2. OT & IT Support: • Serve as the primary point of contact for manufacturing stakeholders to manage and support OT and IT infrastructure. • Ensure operational readiness and uninterrupted functionality of systems in collaboration with central IT and vendor teams, maintaining service delivery as per defined SLAs. 3. Compliance and Audits: • Implement OT and IT policies across the manufacturing site in adherence to regulatory standards. • Support audits by ensuring infrastructure compliance with all relevant regulations and industry standards. 4. Risk Mitigation: • Identify risks associated with OT and IT infrastructure projects or site operations. • Develop contingency plans and apply mitigation strategies to prevent disruptions or failures in manufacturing processes. 5.User Experience: • Optimize user experience across the infrastructure ecosystem by addressing technical challenges proactively. 6. Stakeholder Communication: • Maintain clear and effective communication with departments, stakeholders, and end-users to align OT and IT infrastructure strategies with business needs. 7. Collaboration and Problem-Solving: • Partner with central IT, vendor teams, and cross-functional departments to resolve OT and IT infrastructure and network related issues. • Foster a collaborative environment that supports innovation and continuous improvement of infrastructure systems. Knowledge, Skills and Experience • Bachelor's or Master's degree in Computer Science, Information Technology, or a related field, with a focus on OT and IT integration within manufacturing environments. • Extensive experience in managing OT systems (e.g., DCS, SCADA, PLCs, IoT devices) , IT infrastructure (e.g. networks, servers) for manufacturing facilities, IT-OT Integration and OT Security. • Knowledge of OT and IT applications such as MES (Manufacturing Execution Systems), PLM (Product Lifecycle Management), LIMS (Laboratory Information Management Systems), CAD (Computer-Aided Design), Simulation. Tools, and other digital solutions. • Strong presentation and interpersonal communication skills to foster collaboration between IT, OT, and business stakeholders. • Ability to translate technical concepts into business-friendly language for effective stakeholder engagement. • Proven skills in identifying and resolving complex issues within OT and IT systems, ensuring minimal disruption to manufacturing operations. • Ability to make informed decisions in fast-paced, high-pressure environments. • Experience in planning, organizing, and executing OT and IT infrastructure projects, including budget management and vendor negotiations. • Competence in conducting risk assessments and implementing mitigation strategies for project execution. • Familiarity with industry regulations and standards, ensuring compliance for OT and IT systems at manufacturing sites. • Strong understanding of manufacturing business processes and their interaction with OT and IT systems. • Ability to assess the impact of technical scenarios on business continuity and operations. • Ability to adjust to changing business needs and technology trends, leveraging creative problem-solving to maintain system reliability and efficiency. • Expertise in building partnerships with senior management, business units, IT teams, vendors, and regulators to align infrastructure solutions with organizational goal. Leadership Skills • Agility • Strong Communication • Entrepreneurial • Inclusive • Passionate
Posted 1 month ago
8.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Company Description YSK Laboratories Pvt Ltd specializes in producing Directly Compressible (DC) Granules for solid oral dosage forms. These semi-formulated granules allow one-step tablet manufacturing and offer significant benefits to formulation and FDF companies. YSK’s products are developed using proprietary solvent-free technology at a cutting-edge facility near Mumbai that is being established to comply with EU GMP and USFDA regulatory standards. Role Description: This is a full-time, on-site role for a Quality Control / Quality Assurance (QC/QA) Head at YSK Laboratories. The selected candidate will lead the quality function at our upcoming EU GMP- and USFDA-compliant manufacturing unit. The role involves establishing and maintaining world-class quality systems, ensuring compliance with international regulatory guidelines, and managing end-to-end quality operations from raw materials to finished goods. You will report directly to senior leadership and play a key role in audit readiness, documentation, and quality governance. Responsibilities Establish and lead the QA and QC systems for an international regulatory-compliant facility (EU GMP, USFDA). Oversee raw material, in-process, and finished product testing as per pharmacopeial and regulatory standards. Develop and implement SOPs, quality manuals, and documentation systems as per global compliance norms. Prepare for and host audits by global regulatory authorities and international clients. Manage analytical validations, method transfers, equipment qualification, and process validations. Ensure timely review of COAs, BMRs, BPRs, deviations, OOS investigations, and CAPAs. Oversee stability studies, cleaning validations, and batch release activities. Lead the training and development of QA/QC teams on cGMP, data integrity, and regulatory updates. Collaborate with R&D, production, and regulatory teams to ensure compliance from development to commercialization. Maintain supplier and raw material qualification systems in line with international standards. Qualifications Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or related discipline. Minimum 8 years of pharmaceutical QA/QC experience, with at least 3 years in a leadership role. Prior experience in a USFDA or EU GMP-audited facility is mandatory . Excellent understanding of ICH guidelines, cGMP, and global regulatory requirements. Proficient in managing audits, technical documentation, and laboratory operations. Familiarity with solid oral dosage forms, especially DC granules, is preferred. Strong leadership, communication, and problem-solving skills. Hands-on experience with instruments like HPLC, UV, dissolution testers, etc. Proficiency in MS Office; experience with LIMS/QMS systems is an advantage. Willingness to be based full-time at our plant near Mumbai.
Posted 1 month ago
0 years
0 Lacs
New Delhi, Delhi, India
On-site
Key Responsibilities • Laboratory Supervison o Lead and supervise a team of laboratory technicians. o Oversee daily laboratory operations, including scheduling, resource allocation, and workflow Supervision. o Ensure compliance with safety protocols, regulations, and quality standards. • PCR Experimentation o Run and optimize PCR experiments, including protocol monitoring. o Execute complex PCR assays, RNA extraction, and purification procedures. o Troubleshoot technical issues and provide guidance to laboratory staff. • Quality Control o Implement quality control measures to ensure the accuracy and reliability of PCR results. o Maintain documentation of quality control processes and results. o Participate in continuous improvement efforts to enhance laboratory efficiency. • Data Analysis o Oversee data collection and analysis, ensuring accurate and timely reporting of results. o Interpret PCR results and assist in data presentation. o Ensure the secure storage and management of PCR data. • Equipment and Resource Supervision o Manage and maintain PCR equipment, including thermal cyclers and associated instruments. o Coordinate equipment maintenance and repairs as needed. o Monitor and order laboratory supplies and reagents. • Training and Development o Provide training and mentorship to laboratory personnel. o Stay updated on the latest PCR techniques and technologies. o Foster a culture of continuous learning and skill development. Qualifications • Bachelor's or Master's degree in molecular biology, genetics, or a related field. • Several years of hands-on experience with PCR techniques and laboratory Supervision. • Proficiency in primer design, PCR assay optimization, and troubleshooting. • Strong leadership and team Supervision skills. • Excellent organizational and communication skills. • Familiarity with laboratory safety protocols and regulatory requirements. • Experience with data analysis software and laboratory information management systems (LIMS). • Detail-oriented and able to work effectively in a fast-paced research environment. • Proficient in English • Good written and verbal communication • Ability to work in teams • Ability to work under pressure • Customer oriented attitude • Ready to travel at short notice and conduct med-term abroad assignments
Posted 1 month ago
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Accenture
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