279 Glp Jobs - Page 5

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

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

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

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.

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.

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

Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic data for IPQC and FG analysis.; Analytical method validation, OOS and OOT.; Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities.; Training to subordinate and employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification and Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies; (Technical, Functional and Behavioral) Responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data and hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)

Vibonum Technologies Private Limted conducting a Walk-in interview for Quality Control Executives and Officers Production for its OSD Plant at Mysore. Quality Control Executive Total Vacancies - 20, Education: B. Pharm / M. Pharm / M.Sc Exp: 6-8 Years Quality Control Officer Total Vacancies - 20, Education: B. Pharm / M. Pharm / M.Sc Exp: 2-5 Years Work Location: Nanjangud Mysore Walking Address: Sai Vishram Business Hotel, Hebbagodi, 144-C/1, Kirloskar Road, opp. MTR, Bommasandra Industrial Area, Bommasandra, Bengaluru, Karnataka 560099 Google Map: https://maps.app.goo.gl/Pkh8ASL1JFpJv2An8

Key Responsibilities: Oversight of Quality Control activities related to Raw Materials and Packing Materials . Supervision & review of analytical data, documentation & compliance for material release. Handling of Quality Management System (QMS) elements including OOS, OOT, deviations, CAPA, and change controls . Coordination with cross-functional teams for timely review and resolution of quality issues. Ensuring regulatory compliance as per current GMP standards. Leading audits, facing regulatory inspections, and supporting continual improvement initiatives. Candidate Profile: B. Pharm / M. Pharm / M.Sc. with 15 - 20 years of relevant experience in the pharmaceutical industry. Strong exposure to quality control of raw and packing materials in regulated environments. Hands-on experience in QMS implementation and review processes . Excellent documentation, communication, and leadership skills. Must be willing to relocate to Mysore, Karnataka .

About the Role We are currently seeking a data-driven and detail-oriented Program Intern to join the Founder’s Office. This role will involve critical thinking, problem-solving, and analytical thinking to drive operational improvements and support strategic initiatives. The charter for this role will include Work closely with the founder/senior leaders to turn ideas into validated experiments. Dive into industry trends, discover competitor insights while also working on user research. Build a hypothesis to solve the different problem statements, execute, validate and scale the results Align with stakeholders across the org to drive the actionables; be a driving force in cross-functional teams Present findings, recommendations, and progress updates to leadership. Support key projects and initiatives, ensuring they are on track and aligned with the company's objectives Ideal Persona would Prior experience in building a start-up or interning at a start-up. Good communication and presentation skills, both written and verbal. Ability to work collaboratively and effectively with diverse teams and stakeholders. High on agency with first principle problem-solving approach Familiarity with analytical tools like Excel (advanced), SQL, Python, or other business intelligence software is a plus. Strong organizational skills and ability to manage multiple tasks simultaneously. A proactive mindset with a strong ability to identify potential problems and come up with creative solutions.

Job Title: Junior Analyst / Analyst Experience: 1 to 3 years Location: Hyderabad CTC: 2.5 3.5 LPA Qualification: M.Sc. in Chemistry / Analytical Chemistry Preferred profile: from a food testing laboratory background Job Description: We are seeking a dedicated and skilled chemist with 1 to 3 years of experience in HPLC impurity analysis handling within the food testing industry. The ideal candidate should have a strong foundation in analytical chemistry, method development, and instrument calibration. Key Responsibilities: Perform HPLC impurity analysis in accordance with regulatory and laboratory standards. Conduct routine calibration and maintenance of HPLC instruments. Ensure accurate documentation of sample preparation, analysis, and results. Adhere to Good Laboratory Practices (GLP), ISO 17025 standards, and safety protocols. Assist in method development and validation as per standard operating procedures. Maintain and update instrument logs and calibration records to support audit readiness. Collaborate with QA/QC teams to ensure compliance and continuous improvement. To analyze all Food & Agri samples using HPLC as per IS, AOAC, FSSAI , SOP and customer supplied methods. To Calibrate and perform Intermediate checks for all major and minor laboratory instruments such as HPLC, pH meter, micropipette, sonicator etc. To analyze all the food & Agri samples using GC and UV-Visible spectrophotometer as per IS, AOAC, FSSAI and customer supplied methods. To develop, validate and verify methods as per requirement using HPLC & GC. Candidate Requirements: M. Sc - Chemistry. 1 to 3 years of relevant experience in HPLC and GC techniques, preferably in a food testing laboratory. Hands-on experience with chromatographic software and analytical instrumentation. Willingness to work in rotational shifts. Flexibility to relocate to other branches across India including Bangalore, Nellore, Nashik, Mumbai, Ahmedabad, and Noida for deputation or transfers. Strong analytical skills, attention to detail, and effective communication abilities. Regards, Priyanka Jajula Sr. Executive - HR

quality checks on raw materials, in-process, and finished product proper documentation as per GMP standard stability studies, sampling, and lab testing compliance with SOPs, regulatory, and safety guideline audits and assist in CAPA implementation

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legislation, guidelines and customer practices. 10. Approval of Artworks. 11. Undertake and manage regulatory inspections. 12. Responsible to handle the SUGAM portals and Online Drug licencing system and National single window system (NSWS). 13. Complete knowledge on ROW and EU market registration. 14. Query response submission received from various M. 15. Coordination with the relevant departments for completion of Regulatory works.

Job Description Position : Senior Executive Quality Assurance Section : Quality Assurance Grade/Band : 1C Qualification : M.Sc. /B. Pharm. Desirable Experience: 06 - 10 years Followings will be the responsibilities of the position holder: To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance in laboratory. To participate in investigation of laboratory error report, incidents, out of trend and out of specification results and review the investigation report. To handle & coordinate QMS through SolTRAQs. To ensure the effective implementation of QMS through SolTRAQs application system. To participate in investigation exceptions, market complaints and out of specification results and review the investigation report. To act as a laboratory compliance administrator for creation of new users and projects and to review the audit trials. Compliance of QMS related SOPs and records. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. Any other task assigned by reporting manager. JOB FAMILY: Operations Quality t

Walk-In Drive : Analytical Services Required Qualification & Experience: M.Sc. Chemistry/Analytical/M-Pharmacy, with 0 - 3 Years of experience in the field of pharmaceutical industry/CRO setup. Candidate should have knowledge in method development and validations by GCMS /LC-QTOF. Candidate should have knowledge on GLP/cGMP. Good to have experince in E&L. Job Responsibilities Carries out experimentation in the area of GCMS/LC-QTOF for E&L studies. Records experimental data, ensuring clear and accurate transcription of results and calculations. Completes assigned work with quality and in a timely manner. Assists the group leader in instrument qualifications, implementing laboratory procedures and systems. Coordinates with other team members as per requirement. Follows QMS (cGMP/GLP) practices and aspects related to policies, safety and compliance. Performs in-charge duties for the allocated lab/equipment/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned. Demonstrates a strong desire to continue learning and grow personal capability. Performs other duties as assigned. Please bring your Updated CV along with 3 Months Payslips, Recent Increment Letter, Aadhar Card/PAN Card: Date : Saturday, 17th May 2025 Time: 09:00 AM to 4:00 PM Walk-in Interview Location: Daicel Chiral Technologies (India) Pvt Ltd Genme Valley, IKP Knowledge Park, Survey No. 542/2, Koltur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101 Note: Candidates who are unable to walk-In, May send their resume to hr@chiral.daice.com or whatsApp to 7207760479

Vendor approvals (RM/PM) GMP training & implementation Regulatory compliance Product complaints & recall Batch release QMS execution & audits Validation, deviations & change control

Openings for Residue analysis persons in Food Testing - Hyderabad , Navi Mumbai , Ahmedabad Designation : Junior / Senior Analyst Experience: 2- 10 Years Department : Residue Location : Hyderabad Qualification : M.Scs. (Organic Chemistry/Chemistry/Analytical chemistry) Industry : CRO & Testing Laboratory (Third party testing lab ) Roles and Responsibilities: Analysis of Pesticide residues of Food and Agriculture products as per SOPs, IS, AOAC, FSSAI. Method development, validation and report preparation. Operation and Calibration of equipment i.e., LC-MS/MS, GC-MS/MS, Analysis of Pesticide residues in Water samples. Analysis of Antibiotics in Aqua & Marine products, Feed, Milk & Milk products. Analysis of Pesticide Residues in Fruits and vegetables, Milk & Milk products, Feed & Feed Products and Miscellaneous samples. Mycotoxin analysis in Food & Agricultural products and feed samples. Use and calibration of instruments such as Micro Pipettes, Analytical Balance, Micro balance, Centrifuge, Turbo Evaporator, HPLC & GC. Analysis of Residue in food by LC MS/MS,GC MS/MS, method development and validation, food additives, contaminants analysis on HPLC,GC with different detectors, Worked in ISO 17025:2017 and FSSAI approved lab NABL audit will be added advantage. Regards, Priyanka Jajula

Dishman Group is looking for Officer - QC to join our dynamic team and embark on a rewarding career journey Conduct quality checks on raw and finished goods. Ensure compliance with manufacturing standards. Document defects and corrective actions. Assist in internal audits and inspections.

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.

Scientific Business Analyst (Specialist) – ELN What you will do This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role maximises scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree with 6 - 8years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms. Good-to-Have Skills: Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business stakeholders Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job description Position Offers: Designation : QA Officer/Executive Reports to : Head Location : Precise Analytics Laboratory - Thane Wagle Estate Qual. : (MSC Chemistry/Nutraceuticals/Food Science/M Pharm Quality Assurance) Exp. : 2-3 years experience in Food Analysis . Industry : Only pharma company Open position : 1 Roles and Responsibilities 1) Knowledge of analytical methods and Instruments with software 2) Verification of reports of analysis and reports of method validation 3) Verify the implementation of laboratory management system and GLP 4) Maintenance of lab records. 5) Knowledge of ISO 17025:2017 standard. 6) Control of records and documents 7) Knowledge of IQC, ILC, PT testing

Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time.

Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation / verification / transfer in alignment with ICH Q2(R1) guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm

Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH Q2(R1) guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc. ) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment M. Sc. (Chemistry/Analytical Chemistry) / M. Pharm

Role: Officer / Executive - Quality Control Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 2 to 6 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.