144 Method Validation Jobs

Analyst Analysis of raw material, Drug substance (API), drug products by HPLC, GC, UV-Visible Spectrophotometer, IR, SOR Instruments and chemical analysis (wet lab). Calibration of laboratory Instrument like UV-Visible Spectrophotometer, Balances, pH meter, KF Titrator, etc., and Preparation and maintenance of volumetric solutions, buffers, etc Exposure of GMP / GLP / GDP in laboratory. Designation - Officer / Sr. Officer /Executive Experience : 02 - 07 years Must be having experience in API Reviewer Analytical method development and validation of raw material, in-process and finished products by HPLC, GC, Dissolution apparatus. Review of analytical method validation / verification protocols and reports. Communication with R&D, RA, QA and QC department for to resolving method related queries. Preparation of Standard operating procedures (SOP) for all the instruments, equipment and procedures. Designation - Sr. Executive/Asst. Manager Experience : 07 - 12 years Must be having experience in API

Job Description To have good knowledge about all microbiology testing. To initiate Change controls, deviations and CAPAs related to Microbiology. To prepare and review the Microbiology related documents SOPs /EOPs/ GTPs/STPs, Validation / Qualification / Re-qualification , QRM, URS etc. To monitor the Sample invert and online documents. To prepare and execute IQ/OQ/PQ of the new equipment installed. To prepare method validation protocol and report. To ensure online and accurate recording of all cGMP records at Microbiology section and to follow cGMP practices. To ensure the all-time readiness for Internal and External Audits. To ensure the timely completion of AMCs and PMs. Work Experience 7 to 10 years of experience Education Post Graduation in Microbiology or Biotechnology Competencies

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCRs and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Deputy Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs)by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With guidance of scientists, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOPs, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 3-4 years experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

"1) Responsible for Laboratory execution of analytical activities on daily basis and ensuring compliance to the Safety and quality system as per cGMP. 2) Responsible for Laboratory execution of instrument calibration, stability analysis, WRS preparation/Qualification and for procurement of reference standard etc. 3) Responsible for maintaining stock of working reference standards and chemicals required routinely for raw material analysis. 4) Review and release of finished product, inprocess, intermediates, raw material, reaction monitoring results. 5) Responsible for Laboratory execution of analytical method validation/Verification and Method Transfer activites. 6) Coordination for reagents and volumetric solutions preparation, standardization and maintenance. 7) Coordination for maintaining analytical columns of HPLC, GC, IC and spare parts of instruments and Equipments. 8) Coordination of AMC / CMC of analytical laboratory instruments and its calibration. 9) Coordination for disposal of retained analytical samples of raw material, packing material, inprocess and stability samples. 10) Preparation, revision, review and checking of Raw material, inprocess, intermediates, reaction monitoring and finished products specifications and test procedure and departmental SOPs. 11) Planning and execution to review, checking of IQ, OQ and PQ documents of instruments and equipment. 12) Prepare and Review of certificate of analysis (COA) for finished products. 13) Responsible for investigation of incidents and Deviations in coordination with internal and cross functional team 14) Complying EHS promotional activities and complying EHS statutory requirements of the analytical department. 15) Handling of the ICP-MS/ ICP-OES, Ion Chromatography, GC-MS, UPLC,ION Meter and commissioning experience of the product and new Laboratory setup. "

Responsibilities: * Develop analytical methods using HPLC & GC techniques * Ensure compliance with regulatory requirements during validation process * Collaborate with cross-functional teams on method implementation Provident fund Health insurance

Job Description Roles and Responsibilities: Lab Business set up as per testing requests, tender & contracts with customers, Marketing as per Testing facility available in lab, Man power adjustment, Authorisation of SOP, Method Development & Method Validation, Standard Regulation comply with as per norms, Training program arrangement-Plan & impart Technical & Quality related Training to the staffs, evaluate & maintain, Authorisation of Test Reports, Take action for the purchase of consumables, spares of Instruments, chemicals, CRMs, Standards etc., Monitoring & supervising overall activity of the designed lab Experience/ Knowledge Have proper knowledge of water/ waste water/ Textile & Dye/ Chemicals analysis for wet lab Parameters, Spectroscopy parameters, heavy Metals & alloys analysis/ Chromatography testing. Have skills for method development, verification & validation. Have management skills for lab development. Have proper complete knowledge for analytical Instrument like; GC/GC-MS/HPLC/LC-MS/ICP/UVVIS etc. handling/ Calibration/ trouble shooting. Have proper documentation knowledge for Quality standard document

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation Development Quality Assurance Department (Formulation) Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDRs, PDR’s, MFR’s and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Should have experience in IPQA and Analytical QA (OSD/Injectable) Ref to Friends or colleagues. Please Share me update resume: careers@biophore.com Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization • You need to co-ordinate and follow up with external labs including training of their staff. • You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. • You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. • You will have to participate in handling and resolution of laboratory non-conformances with related documentation • You will be responsible for analytical methods and process compliance as per quality assurance requirement. Qualification Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 – 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills • Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies • Efficient in MS Office, Word/Excel/PowerPoint functionalities • Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. • Ability to understand analytical methods defined by global and local bodies • Ability to resolve analytical issue associated with different product matrix. • Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. • Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate • Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills • Systematic approach and strategic thinking • Possess excellent interpersonal skills, communication, coordination, and time-management skills • Ability to independently handle teams • Excellent oral/written communication and articulation skills • Passion for people development • Ability to prioritize work and change focus quickly • Ability to delegate effectively Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. 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/#!/

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025. Requirement for Executive - FAR&D - Formulation Analytical Research & Development(FAR&D) Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting. Write cGMP Quality documents including Standard Operating Procedures, laboratory equipment procedures and investigational protocols. Excellent, enthusiastic, clear communication skills, both written and verbal, with a diverse audience are critical to the success of this position. Proven ability to interact with cross - functional and cross - cultural teams. Previous experience of running analytical techniques such as HPLC, Dissolution, KF, IC with the ability to extract and prep various samples in a variety of forms. As this role involves liaising with other departments on a regular basis, you will need good communication skills and the ability to work effectively as part of a team. Note : Formulation Quality Control Candidates also eligible. Interview Date : 27-06-2025 Department : Formulation Analytical Research & Development(FAR&D) Experience : 1 to 6 Years Qualification : M. Pharmacy / M.Sc. / B Pharm Position: Executive Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue Details MSN Laboratories, R&D Center,Pashamylaram, Hyderabad

Role & responsibilities- Conduct analysis of samples using HPLC, GC, Spectrometer, and other basic analytical instruments of the lab with experience in developing and validating HPLC/GC methods Analysis of Sugars, Alcohols, Antibiotics, enzymes, active ingredients, and raw material using HPLC/GC Providing Technical support for internal and external stake holders Being the clear R&D player by working closely with cross-functional teams to drive execution across multiple projects while maintaining and achieving timelines to ensure speed to market. To conduct analysis of samples and provide inputs to R&D/QC teams Required Skill Sets: Hands on experience on HPLC, GC, Spectrometer, and other basic analytical instruments of the lab with experience in developing and validating HPLC/GC methods Experience in analysis of Sugars, Alcohols, Antibiotics, enzymes, active ingredients, and raw material using HPLC/GC Fair understanding of ISO/IEC 17025, ISO 9001, ISO14001, ISO 22000, ISO18001 Lab safety & GLP management

Qualifications required: Bachelors /Masters (2-10 Years of experience in Bioanalytical Department only) Role and responsibility: 1. To work on the method development / validation / study sample analysis using HPLC, LC/MS/MS techniques as per principles of GLP, SOPs and approved protocols. 2. To plan and monitor the laboratory work involving the various processing techniques, analytical methods and standard operating procedures (SOPs) and complying with the principles of Good Laboratory Practices (GLP) as well as approved protocols to ensure the quality, integrity and reliability of the results. 3. To establish quality control program and safety of the staff and to establish corresponding corrective actions. 4. To review the raw data forms and chromatographic data sheets 5. To electronically transfer the data duly checked with the raw data and chromatograms to Pharmacokinetics department for PK analysis. 6. Review of Method SOPs, bio-analytical reports of Method Validation and Studies. 7. Review and/or approval of operational SOPS and Method SOPs. 8. Training of personnel. 9. Responding to queries from Sponsor and/or regulatory authorities.

To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control. Analysis of In-process, finished products, stability samples of various formulation products: oral solids, Topical, cosmetics. Responsible for investigation and initiation of change control, Laboratory incidents, CAPA, OOS, OOT. To Co-ordinate with Quality control Manager to prepared the Analytical Method Validation protocol and Report. To perform the analytical method validation as per requirmnet. To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control Also having sound knowledge about data integrity, ALCOA principals and respective regulatory guidelines.

About Apotex Inc. Job Summary Execution of analytical method optimization /development, validation/ verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes( SDC) and other procedural updations.Preparation of method validation/verification protocols and reports. Job Responsibilities Execution of Method optimization / development studies. Method validation/ verification of In-house methods, Compendia, SDC, MLCM and Cleaning Analytical methods by adhering to the regulatory procedures. Preparation of Method verification/ Method transfer Protocols and reports. Execution of Method transfer analysis and reporting. Execution of analytical studies related to Regulatory queries/submisiion requirement. Perform all work in accordance with all established regulatory compliance and safety requirements. Responsible for the activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality system. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education MinimumMSc/BPharm or any equivalent degree. Knowledge, Skills and Abilities Command on Microsoft-Office (Word, Excel). Knowledge in Method optimization/development activities. Best in effective completion of work activities to meet the time lines. Able to perform multi parameter analysis on HPLC instrument. Experience: Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Description: The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the labs continuous development through training and adherence to SOP Essential Functions: Candidate should have worked at least 3- 5 years in injectable ARD. Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc. Prepare method development report along with tentative analytical method. Attain method transfer activity. Method validation like Dissolution, Assay, Related compound and Residual solvents etc. Preparation TT report To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory. Preparation of study protocols with respect to Laboratory. Development batch stability analysis as per stability protocols Responsible for COA preparation and release of development sample against TRF. Additional Responsibilities Taking responsibility to give training to junior for on job training Attend technical workshop /seminar and explore new technique and technology at work place

Job Description Accountable to ensure timely initiation, handling, tracking and closure of QAMS elements like change control, deviation. LIR, CAPA, OOS, OOT and their investigations. To prepare/ review Analytical validation protocols / Study protocols and their reports/method transfer report. Batch release/stability sample/Method validation analysis. QC lab training coordinator Work Experience 7to 14 years Education Post Graduation in Life Science or Biopharmaceutics Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent

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, Job Summary Job Title Research Associate II Location Whitefield, Bangalore Shift General Essential Duties And Responsibilities Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines, Make sound technical recommendations in routine analytical activities Provide analysis/redesign of key experimental procedures, Produce scientific experimental data based on written procedures like method of analysis, protocols etc Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc Provide input to select analytical techniques and procedures to solve problems within area of responsibility, Apply technical theories and principles to projects within area of expertise, Independently analyze and propose solutions to research challenges Learn newer analytical techniques to enhance the capability and productivity, Author documents like Method of analysis/ protocols/ reports Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory, Participate and take ownership of equipment installation and qualification activities as per Baxters QMS, Document laboratory work performed per Baxters GDP, Work according to appropriate quality standards and quality principle (e-g , Data Integrity, ALCOA) Follow Baxters Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement, Qualifications Hands-on experience in chromatographic and/ or spectral techniques like LC-MS/MS, GC-MS, and/or ICP-MS/ ICP-OES, Operation of analytical tools/ instruments (weighing balances, pH meters etc ) and wet chemistry sample preparation techniques, Should have analytical problem-solving skills, high learning agility, innovative experimental attitude along with good presentation skills, Excellent written and verbal communication skills in English, Demonstrates an inclusive attitude and an ability to collaborate with team members and cross-functional team members for project deliverables, 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, Provide and accept critical feedback from others in a constructive manner, Adapt to changes and have an agile mindset, Embrace diversity and inclusion, value differences, Education And/or Experience Educational Qualification: Postgraduate/ Ph D in Pharmacy/ Chemistry or related field (M Pharm / M Sc / Ph D ) Professional Experience: 6 to 10 years of relevant experience 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,

Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-3 years of experience in Bioanalytical Lab.

Required 1-2 years' experience in Analytical Research (Quality Control) Analytical Method Validation by using HPLC Hands on experience in handling HPLC. Will Be Preferred for shift working Required Candidate profile Knowledge about GLP Should have handled instrument like HPLC, GC, UV, Potentiometer, KF, Polarimeter, Dissolution etc. Should experiencing in Analytical Method Validation. Perks and benefits Mediclaim, 28 PL, 5 Days working, Birthday Leave

QC Daily Analysis Conducted tests Assay and Dissolution KF ,PH Preparation of solutions for HPLC Analysis Documentation preparation like SOP,MOA,MSDS,STP

Description: The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the labs continuous development through training and adherence to SOP Essential Functions: Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc. Prepare method development report along with tentative analytical method. Attain method transfer activity. Method validation like Dissolution, Assay, Related compound and Residual solvents etc. Preparation TT report To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory. Preparation of study protocols with respect to Laboratory. Development batch stability analysis as per stability protocols To attain and complete self-training through QMS. Responsible for COA preparation and release of development sample against TRF. Additional Responsibilities: Raise indents, prepare Capex, and manage laboratory inventory. Attend technical workshop /seminar and explore new technique and technology at work place

Role & responsibilities Must have experience in Analytical Method Development. Must have Analytical Method Validation Handling HPLC Apply only API background candidate Preferred candidate profile Male candidate preferred

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

Job Description To have good knowledge about all microbiology testing. To initiate Change controls, deviations and CAPAs related to Microbiology. To prepare and review the Microbiology related documents SOPs /EOPs/ GTPs/STPs, Validation / Qualification / Re-qualification , QRM, URS etc. To monitor the Sample invert and online documents. To prepare and execute IQ/OQ/PQ of the new equipment installed. To prepare method validation protocol and report. To ensure online and accurate recording of all cGMP records at Microbiology section and to follow cGMP practices. To ensure the all-time readiness for Internal and External Audits. To ensure the timely completion of AMCs and PMs. Work Experience 7 to 10 years of experience. Education Post Graduation in Microbiology or Biotechnology Competencies

Role & responsibilities Implement norms for safety culture and 5S in laboratory Provide support and execute analytical method development and validation Coordinate for analytical testing and reporting Execute calibration of various analytical instruments as per schedule Adhere to ADL department policies and SOPs Comply with statutory and regulatory requirements Eligibility Individuals who have cleared 10th and 12th in first attempt (50% and above) MSc (50% and above), with no academic gap. Interested candidates can share their CV to juhi_bhavsar@atul.co.in or call on 81605 01583

Qualifications required: Bachelors /Masters (2-6 Years of experience in Bioanalytical Department only) Role and responsibility: 1. To work on the method development / validation / study sample analysis using HPLC, LC/MS/MS techniques as per principles of GLP, SOPs and approved protocols. 2. To plan and monitor the laboratory work involving the various processing techniques, analytical methods and standard operating procedures (SOPs) and complying with the principles of Good Laboratory Practices (GLP) as well as approved protocols to ensure the quality, integrity and reliability of the results. 3. To establish quality control program and safety of the staff and to establish corresponding corrective actions. 4. To review the raw data forms and chromatographic data sheets 5. To electronically transfer the data duly checked with the raw data and chromatograms to Pharmacokinetics department for PK analysis. 6. Review of Method SOPs, bio-analytical reports of Method Validation and Studies. 7. Review and/or approval of operational SOPS and Method SOPs. 8. Training of personnel. 9. Responding to queries from Sponsor and/or regulatory authorities.