144 Method Validation Jobs - Page 6

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Gurugram) Accountabilities: This position is accountable for critically reviewing data and documents generated by Analytical Research Department and Product/Packaging development department which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Responsibility: Perform thorough review of raw data (pertaining to R&D related activities (viz. Analytical Method Validations /Analytical reports / Analytical Method Transfer / Product Development Report etc. ) compiled by respective department & already reviewed/approved by R&D Quality/QA and ensure the accuracy, completeness and integrity of data/document meant for regulatory submission to USFDA. Review of supporting documents like user log books, attendance records & electronic data, if any, (related to documents/data meant for USFDA submission). During review, ensure the compliance of employee Certification for all documents (R&D related data) intended for USFDA regulatory submission. Coordinating with stakeholders (Regulatory affairs, Analytical research & Product/Packaging development research etc. ) for raw data for ODR review. Critically review R&D related deviations (if any) during pre-submission review of documents/data related to filing for USFDA. Audit the pre-submission data and report any non-compliance activities to immediate Manager. Documentation of pre-submission audit checklists and worksheets of the product. To scan, review, and load the documents/data in Laserfiche and promote to ODR Manager with audit checklists and worksheets. Any other responsibilities which are appropriate and/or assigned by the department head. Education and Job Qualification: Minimum of a Bachelor degree in Pharmacy, Chemistry or related field. Experience: 08-12 years Industry: Pharmaceutical Experience: Experience in analytical laboratory having handled the latest analytical instruments Knowledge of GxP, cGMP and regulatory requirements ICH / USFDA guidelines Knowledge of QC Laboratory test procedures, Method validation, and Analytical method Transfers, API & Finished Products testing procedures and Stability testing procedures. Strong skill to review the Laboratory data including data in electronic format

• Perform analytical testing using advanced instruments like HPLC and GC. • Conduct dissolution analysis using HPLC and UV methods • Carry out method verification and transfer for various analytical procedures

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

a. Candidates should have hands on experience in qualification and calibration of instruments like HPLC/Dissolution/UV/GC/IR/KF. b. Candidate should be well conversant with GXP, QMS and SOPs preparation. c. Should able to work on software like Empower, LIMS, Nichelon, QAMS & DMS. d. Qualification : M.Sc ./M. Pharma/B. Pharma. e. 4-7 years of experience will be preferred

The Opportunity Avantor is looking for an Associate for the Customer Support team. Its an entry level position; provide initial technical product support to customers by handling inquiries and troubleshooting basic technical product-related issues. Gather information to identify and assess the nature of the problem. Record incident in a tracking system to maintain log of product issues for escalation and product development teams. Typically refer to transcript or established process in training manuals and guides to recommend solutions. Escalate complex issues to higher-level technical product support specialists or management. What were looking for Education: Post-secondary education or equivalent job experience; college degree preferred but not required. Experience: 0-3 years of experience in mining or commercial assay laboratory or related field required. Preferred Qualification: Computer skill and aptitude to operate a variety of computer software programs and systems is required. Exceptional communication and interpersonal skills. Display ability to be a strong team player. Excellent organizational skills. Skilled in relationship building is required How you will thrive and create an impact: Conducts sales calls in order to ascertain customer needs and/or to close sales. Seeks out new sales opportunities. Prepares expense reports. Prepares and evaluates territory reviews. Frequently travels to customer locations to evaluate onsite customer care needs. Continually enhances product knowledge as well as sales and customer applications skills. Maintains specific account records as required by management. Maintains awareness of territory and overall sales and profitability goals. Reports security and/or health and safety infractions or potential infractions in a timely manner and to the appropriate contacts. Performs other duties as assigned. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes peoples lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his moms voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. 3rd party non-solicitation policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation

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

Supervision of Sampling, Sample preparation, Sample Analysis, Instrument Calibration, Documentation etc.

We are hiring for a Public listed BSE / NSE - Pharma - API / Crop Protection / Animal Health Intermediates Mfg CDMO / CRAM Company. Role : Team Leader - ADL Title : Sr. Scientist R&D Centre Level : Deputy Manager CTC : Ceiling Rs 15 Lpa Experience: Minimum 14 years to Max 18 years Those working at R&D Centres of Crop Sciences / API / Specialty Chemicals are only eligible. Formulations / Vaccines / Bio labs are not eligible. Formulations Qualification : Full Time M.Sc in Organic Chemistry / Analytical Chemistry only. Those in other specialisation of Chemistry are not eligible. Those with Correspondence Masters degree won't qualify. Location: Pune Saturdays: 2nd / 4th Not working Local Company Transport on the major Trunk Road available. Those working in QC Labs not eligible. Those working in Foods Lab not eligible. Those working in Testing Laboratories should not apply. Role: To follow Good laboratory Practices. To follow the procedures mentioned in SOP's and General test Procedures To ensure availability of respective working standards/samples for method validation and method transfer activity To monitor periodic calibration of instruments as per the schedule To follow all safety standards while working To fulfil the requirement of RA department for different filings To review method validation data & preparation of respective protocol reports To ensure documentation of analytical activities as per Co. policy To provide complete support for internal & external Audits at Pune location To develop suitable analytical methods to support cross functional teams To prepare and review method validation protocols, data and reports

Responsibilities: Conduct wet analyses and method validations Ensure compliance with industry standards and regulatory requirements Maintain cleanliness and safety protocols in the lab environment Share cvs to ramya_n@hikal.com

Key Responsibilities Quality Strategy & Planning Develop and implement quality control standards, procedures, and policies. Define inspection criteria and quality benchmarks. Team Management Lead and supervise a team of quality inspectors or analysts. Provide training and guidance to QC staff. Manage and supervise QC laboratory activities Use effective negotiation skills to drive alignment and resolve conflict Inspection & Testing Oversee routine inspections and testing of raw materials, in-process, and finished products. Ensure compliance with internal and external specifications and regulations. Documentation & Reporting Maintain detailed records of quality control activities. Analyze QC data and generate reports to identify trends and areas for improvement. Compliance & Audits Ensure compliance with ISO, GMP, or other industry-specific standards. Coordinate and support internal and external audits. Problem Solving Investigate product quality issues and customer complaints. Implement corrective and preventive actions (CAPA).

We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. Key Responsibilities: - Lead and manage chemical characterization studies, including planning, execution, and reporting of results. - Develop study protocols and ensure compliance with regulatory guidelines and internal standards. - Coordinate and communicate with cross-functional teams. - Analyze and interpret data, preparing comprehensive reports and presentations for internal and external stakeholders. - Mentor and train junior staff in scientific techniques and best practices. - Ensure that laboratory safety protocols are followed and maintain a clean and organized work environment. - Stay current with industry trends and advancements in chemical characterization methodologies. Qualifications: - Ph.D. or equivalent degree in Chemistry, or a related field. - A minimum of 10 years of experience in chemical characterization or a similar role within a laboratory setting. - Expertise in techniques such as LCMS - QTOF, GCMS, NVR, ICPMS, IC and other relevant analytical methods. - Strong project management skills with the ability to lead multiple projects simultaneously. - Excellent communication, organizational, and problem-solving abilities. - Familiarity with regulatory requirements and guidelines in the pharmaceutical or biotechnology industry. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation to completion, ensuring adherence to regulatory standards and internal protocols. 2. Design study plans and methodologies that are scientifically sound and aligned with project objectives, including the selection of appropriate analytical techniques and equipment. 3. Coordinate with cross-functional teams, including project managers, chemists, and quality assurance personnel, to ensure effective study execution and communication. 4. Review and approve study protocols, analytical methods, and reports to ensure accuracy, compliance, and scientific integrity. 5. Provide technical expertise and guidance related to chemical characterization, including the interpretation of analytical data and results. 6. Ensure that all studies are conducted in compliance with Good Laboratory Practice (GLP) and other relevant regulations. 7. Manage study budgets and timelines, identifying potential risks and implementing mitigation strategies to ensure successful project delivery. 8. Train and mentor staff on appropriate methodologies and regulatory requirements related to chemical characterization studies. 9. Participate in project meetings, presenting study findings and progress updates to stakeholders, and incorporating feedback into study design and implementation. 10. Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting chemical characterization and related fields. 11. Facilitate communication with regulatory agencies as needed, providing data and documentation to support submissions and inquiries. 12. Contribute to the continuous improvement of departmental processes and methodologies, ensuring best practices are followed in study design and execution.

To Lead and manage day to day activities at the Lab not limited to only recording data, maintaining equipment, including protecting the accuracy and efficiency of the experiments while keeping the lab organised. Contact : Hr.Apurva (8799969317)

Job Role: Analytical Chemistry-Analyst Department : Analytical - BGRC Job Location : Bangalaore About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Core Purpose of the Role: This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, etc Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. • Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers • Shall have experience on Good documentation/laboratory practices such as ALCOA+ Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments • Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures • Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control) Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects • Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure • Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity • Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas Behavioral Skills Good Interpersonal skills • Self-time management • Good Team player Polite/Good Communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence • Integrity • Professionalism Specific requirements for this role Experience Should have 3-6 years of experience in analytical lab Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, and QC other analytical instruments • Theoretical knowledge in Chromatography and spectroscopy technique • Good documentation/laboratory practices such as ALCOA+ Able to follow work instructions and perform the tasks under the supervision of the Team leader • Preparation and Maintenance of all the documents • Good knowledge of MS-office (word, excel, ppt) Education M. PharmM.Sc. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Position: QC Executive Location: Derma Unit, Karakhadi Role & responsibilities Analysis of In-process, Intermediates, Raw material, Packing material, Finished products, Stability study, Hold time study, Process validation, Cleaning samples, Vendor development and any analysis allocated by team leader and release with proper documentation.. Responsible for ensuring the quality and purity of pharmaceutical products using High-Performance Liquid Chromatography (HPLC) techniques Prepare samples for HPLC analysis according to established SOPs and specifications. Analyze HPLC data, interpret results, and generate reports documenting test results and deviations. Ensuring analysis is performed compliance to GLP. Ensuring analysis raw data is documented on-line. Initiation, Completion and filing of Daily analysis reports. Ensuring any abnormal results, incidents, deviations, discrepancies are reported immediately to the reporting Section Head. Ensuring all relevant log entries are made for every activity wherever applicable. Supervise compliance to all cGMP, GxP or any other regulatory requirements including EHS requirements. Report any quality concerns or suggestions for improvements to Department Head. Execute and supervise all tasks and activities as per the applicable SOPs and company policy. To maintain the safety norms while working in lab. (e.g. Wear goggles, PPE, Disposal of sample/media as per procedure etc). Ensuring analysis is performed as per valid procedures and by using calibrated instruments / Standards. Ensuring self-discipline with respect to wearing aprons, attendance and personnel hygiene and inter relations. To perform Labware LIMS related activities. Any other assignment given by the Section Head or Department Head.

Perform Polymorph screening as per guideline. Follow cGMP Documentation and EHS compliance at workplace Perform Virtual and Experimental Screen and evaluate all literature that relates to solid-state issues. Screen new forms by performing stress tests and File ASAP new forms in patent application Analyze laboratory samples by XRD, DSC, TGA and other characterization techniques. Assess kinetic stability and interconversions and produce scheme of all polymorphic transitions Produce solubility curves of different polymorphs and assess thermodynamic stability relationships Develop detection methods to assess polymorphic purity and monitor in the laboratory samples Support the development of the crystallization process with full characterization Monitoring stability and physical properties of micronized/milled materials Perform calibration, method development, method validation, and troubleshooting using various instruments like PXRD, DSC, TGA and Particle size analyzer Knowledge of various regulatory guidelines w.r.t. method development, product development, and documentation. Your experience and qualifications MSc Chemistry / B Tech (Chemical Engineer) with 1-5 years of experience in relevant industry and profile

Roles & Responsibility: Perform method development, method validation and study sample analysis under supervision of Project Manager (s). Passaging of cells as well as performing cell based assays while maintaining aseptic conditions in cell culture laboratory. Perform ELISA & other Ligand Binding Assay according to study protocol guidelines and/or SOPs Processing of specimens to support the clinical studies. Preparation of required reagents and solvents. Preparation of SOP(s) and work instruction. Following GLP, GDP, GCLP & other good practices. Desirable candidate: MSc BioTech/ Biochemistry/ Microbiology or BTech Biotech fresher. 0-1 year of relevant experience will be preferable. Sound knowledge on Immunology. Good communication skills, analytical skills and team coordination.

Job summary We are seeking an individual to perform the Preventive Maintenance and Break Down Maintenance of Analytical Equipment's present in Quality Control . Roles & Responsibilities To perform the preventive and breakdown maintenance of analytical equipment's or Instruments like HPLC, UPLC, GC-HSS, Dissolution Test Appratus, Titrators, FTIR, UV-VIS Spectrophotometer,.... To update the preventive maintenance plan whenever addition of instruments or match the calibration schedule. To prepare the task lists for all analytical equipment's and update them in SAP. To perform the preventive maintenance as per the PM schedule. To make sure of closing the generated PM orders in SAP after performing the PM. To ensure that the instruments / equipment are used with utmost care and as instructed in the relevant SOP. To attend the breakdown's and close notification or order of the instrument /equipment after the Completion of breakdown maintenance. To be a part of investigating the incidence related to instrument Responsible for the maintaining of required spares for all instruments in warehouse. To get the quotations for the required spares and services for the maintenance of the instruments. To generate the purchase requisitions for the required spares and services. To perform the PM in the given frequency within the given period. Adhering to the allotted shift schedule with right time. If any changes prior permission shall be taken from Group leader. Qualification Educational qualification: An B.Tech. or any Degree in Instrumentation, Mechanical, Electronics, Electrical. Required Work experience : 3 to 6 years Skills & attributes: Technical Skills • Hands-on Experience on maintenance of Waters HPLC (Arc, e2695), Agilent HPLC (1200, 1260 Infinity), Agilent GC-HSS (7890, 8890, 7897, G1888), Dissolution Testers (Electrolab, Sotax), Metrohm Titrators. • Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP). • Basic knowledge in SAP usage Behavioural skills • Prioritizes effective communication and demonstrates a performance-oriented mind-set. • Effective verbal and written communication skills. • Performance-oriented approach, consistently striving for high standards. • Demonstrates flexibility in working shifts and a clear understanding of team dynamics. Additional Information About the Department Quality Control Formulations For more details, please visit our career website at https://careers.drreddys.com/#!/

The position is one of a leadership role. Work experience of at least 10 years in the Indian BFSI, real estate and infrastructure domain, of which at least 6 years should be in leading a team of 8 to 10 members wherein the candidate should have worked on and be centrally involved in project management and driving research and consulting engagements with or within banks, HFCs, NBFCs and corporates. Ability to drive business development and acquisition efforts in the above sectors is also critical.