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1.0 - 2.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Role & responsibilities The individual has to follow safety/quality procedures of lab. Any other relevant task assigned by the lab leader. The individual must have the capability to visually inspect, collect, and analyze samples of raw material, packaging material, finished goods, intermediates according to standard analytical procedures. Follows procedures for basic calibration and maintenance of equipment Maintains the laboratory in a clean and organized manner. Skill Required The individual is responsible to work in QC Lab compliant with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP). Knowledge & Skills: Able to do understand basic principles of analytical tests & instruments. Person must also have knowledge and capability to operate Lab instruments. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.
Posted 3 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Quality Control Department In Formulation Division @ Vizag Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- Hotel Cygnett Inn Ramachandra , 31-2-4/5, NH16, opp. All India Radio Station, Kurmannapalem, Visakhapatnam, Andhra Pradesh 530046 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 3 weeks ago
3.0 - 8.0 years
5 - 10 Lacs
Ahmedabad
Work from Office
Qualification : BSC/MSC Organic/Analytical/Industrial Chemistry Experience : Minimum 3 years of experience in a chemical/pharmaceutical industries. Should have strong communication skill Handling & Calibration of instruments like HPLC, GC, KF, IR, UV, Viscosity, Tintometer Sampling and analysis of raw material as we'll as finish good ETP sample analysis - pH, COD, TDS. MLSS, TS, TSS Good Knowledge of physical as we'll as chemical testing of a material Doing wet chemical analysis Normal solution preparation and standardisation Working knowledge of nitrite value, acidity, chloride, sulphate, iodometry Working knowledge of Cloud point, Hydroxyl value, Saponification value Documentation work of Quality control as per GLP Preparing COA, MSDS and other quality reports, SOP, STP Should have experienced audit ie NABL, ISO, GMP, USFDA Reporting to : Manager - QA & QC
Posted 3 weeks ago
3.0 - 5.0 years
2 - 5 Lacs
Pune
Work from Office
Planning /Analysis (Routine and stability and QBD analysis) of ongoing projects by performing analysis of various tests (e. g. Dissolution, assay, Related substances test, or as per requirement) within given Time. Analytical Method development as per current SOP/guideline wherever required. Regulatory query/Plant Query related analysis for different products. To follow Good Laboratories practice while working. Documentation and compliance and review of data generated on all analytical activities as per the GLP/GMP norms and to keep working place neat and clean. Method transfer at plant. Method equivalency, method verification, pharmaceutical equivalency analysis of Pharmacopeial method. Preparation/review of various documents like method transfer waiver, method equivalency report, cleaning validation report SOP, T-STP/FP STP etc. Coordination with team members, superiors and subordinates within the group and across all relevant groups (customers) to achieve target timelines. Procuring of columns, reagents and miscellaneous items for analytical product development/support. Whenever required give training to subordinates/colleagues to upgrade their knowledge and current requirements. Education Masters in Analytical Chemistry or Analytical Chemistry Post Graduation in Pharmacy or Analytical Chemistry
Posted 3 weeks ago
1.0 - 3.0 years
5 - 10 Lacs
Hyderabad
Work from Office
Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 3 weeks ago
10.0 - 15.0 years
15 - 20 Lacs
Hyderabad
Work from Office
Role & responsibilities Responsible for performing and overseeing ELISA (Enzyme-Linked Immunosorbent Assay) testing, ensuring high standards of accuracy, quality control, and efficiency in laboratory operations. This role involves leading a team of technicians, optimizing assay protocols, managing lab inventories, and analyzing data. Deliver GLP and non-GLP ELISA/LBA, MSD ECL, and Luminex Multiplex Analysis for Pharmacokinetic (PK), Toxicology (Tox), Biomarker, Bioavailability (BA), Biosimilar, Immunogenicity, and other bioanalytical studies. Complete Method Development or Method Transfer of customized, robust, and highly sensitive Chromatographic Assay using necessary sample preparation Develop, validate, and optimize ELISA protocols and procedures to improve lab performance and efficiency. Conduct and supervise ELISA testing for various research, diagnostic, and quality control purposes. Analyze data generated from ELISA experiments, including quantification of analytes and assessing assay performance. Analyze and interpret test results, ensuring proper documentation and reporting of data. Well versed in Operation and Calibration of ELISA Instrument with advancements in ELISA technology and laboratory best practices. Manage Incidents, deviation and investigations of ELISA results with documentation. Prepare and review of SOPs, work instructions, method development and method validation protocols and reports. Ensure compliance with safety and quality standards, including SOPs (Standard Operating Procedures) and regulatory requirements. Client management, including acting as company representative to help existing and potential clients, and serving as operational lead in client visits, facility and pre-qualification audits. Supervise junior and senior scientific staff, including evaluating performance and ensuring that all bioanalytical service activities are performed in a safe manner and according to SOPs and GLP regulations. Train, mentor, and provide technical support to junior lab staff and technicians. Work with cross-functional teams to support ongoing research or clinical studies. Preferred candidate profile Bachelor's or Master's degree in Biology, Biochemistry, Biotechnology, or a related field (PhD preferred). Minimum of 8-10 years of experience working with ELISA assays, including advanced experience in assay development and troubleshooting. Ph.D. plus 8 years relevant industry experience or 6 years CRO experience Master's Degree plus 13 years relevant industry experience or 9 years CRO experience Bachelor's Degree plus 14 years relevant industry experience or 12 years CRO experience Interested and suitable applicants can mail their updated CV to hr@qpsbioserve.com
Posted 3 weeks ago
2.0 - 5.0 years
7 - 8 Lacs
Pune
Work from Office
Establish, maintain, and scale mammalian cell lines including adherent and suspension cultures under sterile conditions.Perform routine cell-based assays such as viability, proliferation, cytotoxicity, reporter assays, and high-content imaging.
Posted 3 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Quality Control Department In Formulation Division @ Jadcherla Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 3 weeks ago
18.0 - 25.0 years
35 - 50 Lacs
Hyderabad
Work from Office
We are looking for a dynamic and experienced General Manager to spearhead Sales and Marketing efforts within our CDMO markets at Chieron Active Ingredients. This pivotal role demands a seasoned leader capable of building and nurturing a robust CDMO business, leveraging extensive industry knowledge and contacts. The ideal candidate will possess a comprehensive understanding of the entire product development lifecycle, coupled with strong technical acumen and familiarity with global pharmaceutical regulations. This individual will collaborate closely with technical leaders, both internally and externally, to drive business growth. The role requires a strategic mindset, patience, and unwavering persistence, given the long sales cycles inherent in the CDMO sector. The General Manager will be responsible for developing and executing sales strategies, managing key accounts, ensuring regulatory compliance, and fostering innovation within the CDMO division. They will also play a crucial role in identifying and capitalizing on emerging pharmaceutical industry trends to maintain Chieron Active Ingredients' competitive edge. This is a high-impact position for a results-oriented professional eager to shape the future of our CDMO business. Job Details: Industry: Active Pharmaceutical Industry Department: Sales and Marketing (CDMO) Role: General Manager (Sales and Marketing for CDMO Markets) Location: Hyderabad Experience: 18 to 25 years Employment Type: Full-time Qualifications: Bachelor's or Master's degree in Chemistry, Pharmacy, or a related field. MBA preferred. Responsibilities: Strategic Leadership & Business Development Lead the development and execution of the CDMO sales and marketing strategy to achieve revenue targets and market share growth. Identify and evaluate new business opportunities within the CDMO landscape, including market trends, competitive analysis, and potential partnerships. Develop and maintain strong relationships with key decision-makers at target pharmaceutical companies. Oversee the preparation and presentation of compelling proposals and presentations to prospective clients. Monitor and report on market trends, competitor activities, and customer feedback to refine sales and marketing strategies. Represent Chieron Active Ingredients at industry conferences, trade shows, and networking events to enhance brand visibility and generate leads. Sales Management & Key Account Management Manage and mentor the CDMO sales team, providing guidance, training, and support to achieve individual and team goals. Develop and implement effective sales processes and tools to optimize sales efficiency and conversion rates. Oversee the management of key accounts, ensuring customer satisfaction and fostering long-term partnerships. Negotiate contracts and agreements with clients, ensuring favorable terms and conditions for Chieron Active Ingredients. Monitor sales performance metrics and identify areas for improvement, implementing corrective actions as needed. Collaborate with cross-functional teams to ensure seamless execution of CDMO projects and deliverables. Technical & Regulatory Compliance Maintain a thorough understanding of API manufacturing processes, pharmaceutical regulations (GMP, GLP), and quality standards. Ensure that all CDMO activities comply with relevant regulatory requirements and industry best practices. Collaborate with the technical and quality assurance teams to address client inquiries and resolve technical issues. Oversee the preparation and review of technical documentation, including CMC sections, regulatory submissions, and quality control reports. Stay abreast of changes in global pharmaceutical regulations and update internal processes accordingly. Participate in client audits and inspections, ensuring successful outcomes and maintaining a strong reputation for quality and compliance. Project Management & Cross-Functional Collaboration Oversee the project management of CDMO projects, ensuring timely completion, adherence to budget, and achievement of quality objectives. Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless project execution. Communicate effectively with clients and internal stakeholders, providing regular updates on project progress and addressing any concerns. Identify and mitigate risks associated with CDMO projects, implementing contingency plans as needed. Track project performance metrics and identify areas for improvement in project management processes. Ensure that all project documentation is complete, accurate, and readily accessible. General Expectations and Past Experiences: Proven track record of successfully building and managing CDMO sales teams and achieving revenue targets in the pharmaceutical industry. Extensive knowledge of API manufacturing processes, pharmaceutical regulations (GMP, GLP), and quality standards. Demonstrated expertise in contract negotiation, strategic account management, and business development within the CDMO sector. Strong technical acumen and ability to communicate effectively with technical leaders, both internally and externally. Excellent communication, presentation, and interpersonal skills, with the ability to build rapport and influence key decision-makers. Experience in developing and implementing sales and marketing strategies to drive business growth in the CDMO market. Proficiency in project management methodologies and tools, with the ability to manage multiple projects simultaneously.
Posted 3 weeks ago
12.0 - 16.0 years
18 - 25 Lacs
Dehradun, Roorkee, Yamunanagar
Work from Office
Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.
Posted 3 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Ahmedabad, Gujarat, India
On-site
Role & responsibilities Responsible for Analytical Method Validation and Method Development activity. Responsible for F&D sample analysis. Responsible for Good Lab Practices (GLP) Activities and its compliance. Responsible for Calibration of lab instruments. Responsible for Preparation and review of Validation Protocols/Reports and Analytical Reports including data. Responsible for Departmental SOP Preparation/Review and its compliance. Responsible for Procurement of analytical and Lab requirements. Preferred candidate profile Key technical skills: Key behavioral attributes: Lateral coordination Team working Policy compliance Task completion orientation Candidates from parenteral or Injectable would only be preferred. Interested candidate can share their resume at [HIDDEN TEXT]
Posted 3 weeks ago
3.0 - 5.0 years
3 - 5 Lacs
Ahmedabad, Gujarat, India
On-site
Role & responsibilities To perform all test for in process product & finish product as per the specification and schedule. To investigate failure of FP / Out of specifications (OOS) and take the corrective and preventive actions (CAPA). To perform and ensure the calibration of instruments as per the schedule. To perform and ensure preparation of reagent / volumetric solution as per schedule. To perform and ensure observation of FP retained samples. To ensure that all documents related to the testing data and related papers are maintained properly. To implement Corrective and Preventive Action (CAPA). To carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To carry out the testing of Raw Material and Packing Material according to approved procedure. To release Raw Material and Packing Material. To carry out the calibration of instruments as per the schedule. To prepare the working standards as per the guidelines and various pharmacopoeias. To ensure the status tag on the released material and transfer such material in the released area. To follow the Good Laboratory practices and Good Manufacturing practices (GMP). To prepare requirement list of chemical & reagent for procurement. To perform the analysis of stability sample as per current specification. To compile the data required for internal quality audit in the plant, as and when required. Preferred candidate profile Managerial skill Problem solving & Decision Making skill Guiding skill Team development skill System thinking Delegation Interested candidates can share their CV at [HIDDEN TEXT] Fresher can also can apply and their CV on the mentioned email ID
Posted 3 weeks ago
2.0 - 6.0 years
4 - 8 Lacs
Noida
Work from Office
" The Position Organization : - Jubilant Biosys Designation Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience.
Posted 3 weeks ago
6.0 - 11.0 years
22 - 27 Lacs
Hyderabad
Work from Office
The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions Documentation (SD) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements: PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement: Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology
Posted 3 weeks ago
1.0 - 3.0 years
5 - 10 Lacs
Hyderabad
Work from Office
Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 3 weeks ago
1.0 - 6.0 years
4 - 7 Lacs
Ahmedabad
Work from Office
Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.
Posted 3 weeks ago
2.0 - 3.0 years
3 - 6 Lacs
Vadodara
Work from Office
Responsibilities: Conduct Laboratory Tests: Perform routine and non-routine laboratory analyses using various analytical techniques and instruments, including: HPLC (High-Performance Liquid Chromatography) UV/Vis Spectrophotometry (USV) TOC (Total Organic Carbon) Analysis FTIR (Fourier Transform Infrared Spectroscopy) Dissolution Apparatus AAS (Atomic Absorption Spectroscopy) Other relevant analytical methods as required Prepare samples for analysis according to established procedures. Operate and maintain laboratory equipment and instruments accurately and safely. Calibrate and perform routine maintenance on laboratory equipment as per established schedules. Maintain accurate and complete laboratory records in accordance with Good Laboratory Practices (GLP) and regulatory requirements. Quality Control: Analyze test data, interpret results, and identify any deviations from specifications. Investigate and troubleshoot any analytical problems or discrepancies. Prepare and review analytical reports and certificates of analysis. Participate in root cause analysis of quality issues and recommend corrective and preventive actions. Laboratory Maintenance: Maintain a clean, organized, and safe working environment in the laboratory. Ensure proper inventory management of laboratory supplies and reagents. Comply with all safety regulations and procedures within the laboratory.
Posted 3 weeks ago
12.0 - 18.0 years
15 - 20 Lacs
Jhagadia
Work from Office
Hello, Greetings for day! Please find the below JD Preparation/ review of standard operating procedure (SOP), calibration procedures, specifications, standard test procedures, general test procedures etc. Conducting training on specification and method of analysis, SOPS and calibration procedures. Handling of QMS documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To ensure timely closure of documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To investigate the laboratory error / incident and its impact on quality and analysis of all samples. Participating as a cross functional team member for investigation of any QMS related issues. To observe and maintain Good Laboratory Practices. To prepare / review documents like stability schedule, hold time study schedule, preventive maintenance schedule, calibration schedule. Co-ordination with outside calibration agencies. To prepare/review instrument qualification data. Coordinating with other departments for smooth functioning of laboratory. Arranging standards required for the analysis. Arranging columns required for analysis. To approved sign in TRF( Intermediate) ,GRN,Hold time sample, stability sample Ensuring training of departmental staffs as per job requirement. Attending training program as per CGMP training schedule. To take part in method validation/transfer/verification activity. To maintain discipline in the laboratory. To prepare the analysis request form and send the sample to contract laboratory for analysis. To take part in customer/regulatory/internal audits. Responsible for follow the health, safety & environment norms as per company policy & procedures. To monitor the good housekeeping practices in all quality control area. To co-operate in achieving the quality control objective. Preferred candidates should be form CDMO industry or somebody who has handled multiple API product and handled 50 members team. Interested candidates can share their update resume and below details on 'jyotsna.sable@aartipharmalabs.com' Total years of exp: Current CTC Exp CTC: Notice Period: Are you open for move to Gujarat: Do you have experience in CDMO/API Manufacturing Industry: what is the team size did you handle?
Posted 3 weeks ago
0.0 - 2.0 years
2 - 4 Lacs
Bengaluru
Work from Office
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Summary The successful candidate for this role will bring familiarity and experience in characterization and failure analysis of polymeric materials pertinent to use in drug and device industry The role requires the candidate to perform polymer material testing at in-house labs and/or coordinate the testing with external testing labs under minimal supervision The individual will write required reports following pertinent internal and external guidelines that enable the eventual use of polymer materials tested by them in drugs or devices manufactured by Vantive, Essential Duties And Responsibilities, Perform characterization and failure analysis of polymeric materials used in multiple applications such as disposables (e-g filters, dialyzers, polymeric connectors etc ), packaging, and container closure materials and container systems, Employ appropriate techniques/methods to successfully and independently execute assignments within negotiated deadlines, Apply technical theories and principles to projects within area of expertise and select appropriate techniques and procedures to solve problems, Document results in laboratory notebooks/ELN according to established GDP procedures, Maintain laboratory reagents, materials and equipment as directed in good order, Create and update equipment SOPs and analytical procedures, participate in ordering of raw materials, analytical materials or equipment, Maintain knowledge of and apply relevant quality and safety requirements including equipment ownership and qualification, Have a working knowledge and understanding of GDP, GLP, GMP and related regulations and guidelines, Qualifications, Demonstrated hands-on experience in polymer characterization (FTIR, DSC, TGA, MFI, etc ), polymer microscopy and associated sample preparation techniques (microtomy/cryomicrotomy), as well as experience in failure analysis of polymers required, The successful candidate will demonstrate high level of passion and interest in polymer science and applications of that knowledge to be an effective problem solver in an industrial setting, Excellent written and verbal communication skills in English, Ability to effectively contribute as an integral member of a project team, Ability to objectively assess, organize, and clearly communicate information, Ability to interpret available information and make recommendations to resolve technical challenges, Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner, Demonstrate inclusive attitude, collaborate with team members and cross-functional teams for project deliverables, Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met, Provide and accept critical feedback from others in a constructive manner, Adapt to changes and exhibit an agile mindset, Embrace diversity and inclusion, value differences, Education And/or Experience, Mastersdegree in a relevant field (e-g , Material Science/Chemistry, Polymer Science/Chemistry) with 2 yearsof relevant professional experience, PhD candidates with dissertation work relevant to polymer characterization, polymer microscopy and polymer failure analysis are encouraged to apply, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,
Posted 3 weeks ago
0.0 - 1.0 years
2 - 3 Lacs
Mumbai
Work from Office
To execute sampling and analysis of Raw materials along with relevant laboratory documentation. To execute analysis of finished goods, In-process, packing materials and cleaning samples along with relevant laboratory documentation. Result reporting after completion of analysis & relevant documentation . Before starting an analysis, following points (but not limited to) must be checked: Check all the instruments on the equipment required for the analysis are in working condition and are in calibrated state. Checking and ensuring proper status labels after confirming availability of all the requirements (as applicable) for analysis such as approved control procedure, analytical protocol, reference standards, chemicals, reagents, GC/HPLC columns, glassware, water preparation equipment, water bath, sonication baths, mobile phase bottle etc . Ensure the online documents pertaining to day-to-day analysis are efficiently completed in timely manner. Reporting the activities daily to immediate supervisor. Ensure timely calibration & preventive maintenance of equipment/instrument. Destruction of respective records & QC Samples like Retention samples of Raw Materials, analyzed samples. To take out the quality reports, Data / Results entry in SAP system. To prepare and maintain the working standards & documentation. Ensure timely raising and closure of deviations, quality events, change controls, OOS/OOT. To execute Analytical Method Validation / Transfer, cleaning validation as per approved procedure & protocol. Preparation and maintenance of Analytical data sheets and Excel spread sheets. Adequate knowledge of all equipment/instruments & their functioning in the laboratory & assist in equipment/instrument qualification activities. Ensuring the quality and integrity of all GxP data and documentation generated. Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111. Ensure fully Engagement and Involvement regarding awareness, clarity maintained related to data integrity. Ensure the 21 CFR Part 11 compliance in the Laboratory. Effective implementation of practices like cGMP & GLP, ISO 9001, ISO 14001, ISO 22000, ISO 18001, HACCP and SQF in QC Dept. To follow and maintain the standard chromatographic practices. Ensuring good house-keeping and accident free working in the Laboratory. To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs, safe, secure storage of hazardous, toxic, explosive, corrosive, irritant materials. Ensure proper maintenance of logbooks in QC lab. To fulfill the analytical requirements of FSSAI regulation. To undergo assigned trainings on cGMP, HSE & departmental procedures / policies. To determine internal and external QEHS issues as we'll as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. To identify & communicate incidents, QEHS non conformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of waste. Masters in Science
Posted 3 weeks ago
9.0 - 13.0 years
35 - 40 Lacs
Vadodara
Work from Office
Designing, executing and interpreting bioassays/pharmacological studies. Knowledge of GLP/GMP. Leading and managing in-vitro/in-vivo projects, ensuring timely completion Mentoring junior scientists, building and leading cross functional teams Analyzing data, preparing reports and presenting to stakeholders Collaborating with other departments, to advance progress of projects
Posted 3 weeks ago
4.0 - 9.0 years
10 - 11 Lacs
Vadodara
Work from Office
Designing, executing and interpreting bioassays/pharmacological studies. Knowledge of GLP/GMP. Leading and managing in-vitro/in-vivo projects, ensuring timely completion Mentoring junior scientists, building and leading cross functional teams Analyzing data, preparing reports and presenting to stakeholders Collaborating with other departments, to advance progress of projects
Posted 3 weeks ago
4.0 - 9.0 years
10 - 11 Lacs
Vadodara
Work from Office
Histopathology evaluation and report preparation of pharmacology studies Planning, designing and monitoring of GLP/Non -GLP toxicity studies in rodent and non-rodent Scientific data collection, interpretation of toxicology data and study report preparation/review.
Posted 3 weeks ago
2.0 - 5.0 years
2 - 3 Lacs
Paonta Sahib
Work from Office
Roles and Responsibilities Conduct stability studies, method validation, and analysis of finished products using techniques such as GC, HPLC, UV-Vis, KF, FTIR, and dissolution testing. Ensure compliance with GLP guidelines and maintain accurate records of all experiments and results. Collaborate with cross-functional teams to resolve issues related to product quality control and manufacturing processes. Develop and implement new methods for analyzing raw materials, intermediates, and finished products. Participate in method development activities to improve existing methods or develop new ones.
Posted 3 weeks ago
3.0 - 11.0 years
6 - 7 Lacs
Medak
Work from Office
Key Roles Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in RD (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in RD activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities. 5. Periodic audits of RD laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. 6. Effective maintenance of RD records, distribution and archival systems. 7. Perform cGMP audit of RD facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory. 8. Ensure RD team is trained for their relevant job function and GMP/ GLP training. 9. Provide quality related inputs to new projects, existing project, up gradations etc. 10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified. 11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site. 12. Establish raw material standards by studying manufacturing/ RD requirements-conferring with suppliers. 13. Responsible to follow the safety and environmental procedures deployed in the site. Graduation and above in Science / Pharmacy
Posted 3 weeks ago
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