15 Method Verification Jobs

You will be responsible for performing microbiological analysis, media inventory, and culture maintenance. This includes executing microbiological method development, method validation, and method verification. In addition, you will be required to perform qualification and calibration of instruments and equipment. It is essential to ensure concurrent documentation of analysis to maintain accurate records. Furthermore, you will be responsible for water sampling and testing to ensure compliance with regulatory standards. Your attention to detail and precision in executing these tasks will be crucial for the successful completion of your responsibilities.,

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Method verification/validation of compendia/pharmacopeial updations, Method verification of SDCs (Supplier Driven Changes) method. Method validation of cleaning verification, Preparation of method verification and validation protocols and reports, Evaluation of SDC, compendial/pharmacopeial updations, Preparation of In-House method and Specification. Analysis of raw material and excipients. Job Responsibilities Analysis of Compendia, raw material samples, Analytical method transfer samples as per method of analysis by adhering to the regulatory procedures. Preparation and review of Memo, Method Verification/ Method validation protocols, Method Verification/Method validation reports, Method transfer summaries. To involve in investigations and excursions as per SOP, to provide technical support during investigations of OOS/OOT results and to identify assignable cause. Compendia changes review, method verification. To perform the cleaning validation as per the protocol. Perform all work in accordance with all established regulatory and compliance and safety requirements. Responsible for preparation and updating of specification and method of analysis as per regulatory requirements and compendia requirements. To be responsible for all activities in the Quality control Laboratory, including cGLP, documentation and implementation of departmental quality system as and when required. To generate and maintain records related to laboratory samples. 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). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Able to perform multi parameter analysis on HPLC instrument. Experience Minimum 2 to 4 years of experience in GMP regulated Pharmaceutical Industry. At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer 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. Show more Show less

Role & responsibilities Perform the calibration and preventive maintenance of the instruments as per the respective schedules. Analysis of raw material / finished products / stability samples / Dissolution profiling for R&D/ Plant support. Analytical Method Development /Verification Assay, Related substances, Dissolution etc . Perform the determination of KF factor, Daily verification of Balances, pH meter, Milli-Q water system, Hot Air Oven, Refrigerator temperature monitoring. Develop/ optimize the analytical methods by Chemical/ instrument analysis Verify/ validate the analytical methods by Chemical/ instrument analysis Preparation / Revision of Specification and Method of analysis for Raw materials / Finished Product / Inactive / Excipients etc Appropriate documentation of results and calculations, preparation of SOPs, specifications and test methods. Interpret results, evaluate data, draw relevant conclusions and give timely feedback to concerned Departments. Analytical Technology transfer of analytical methods by Chemical/ instrument analysis Perform the Impurity standard/ working standard/ primary reference standards. Receiving and filling controlled copy of specifications / method of analysis / SOP / STP etc Operation of various software like Oasis LIMS, Q Edge TMS, Chromeleon etc Preferred candidate profile Qualification: B. Pharm / M.Pharm / M. Sc Experience: Minimum 2 years in HPLC Analysis Development and Validation Perks and benefits Mediclaim

1. Execute validation of analytical methods as per ICH guidelines 2. Method Verification 3. Method Transfer 4. Instrument Handling (HPLC,UV-Visible Spectrophotometer) 5. Documentation & Compliance 6. Audit Readiness & Regulatory Support Perks and benefits Bachelor's Accommodation and Travelling facility

As an R&D Executive at PTC - MORAIYA, your primary responsibility will be to perform analysis of Drug Product and Drug Substances for various test parameters according to the product development requirements. You will be involved in the method development of Drug Product and method verification of Raw Materials. Conducting literature searches for method development and impurity profile of drug products will also be a key part of your role. Additionally, you will be responsible for compiling analytical results and preparing Method Development Reports. Ensuring adherence to Good Laboratory Practices (GLP) in the analytical laboratory is crucial to maintain quality standards. Your contributions in these areas will play a vital role in the overall research and development process at PTC - MORAIYA.,

As a candidate for this role, you will be responsible for working in accordance with organizational compliance requirements. Your main tasks will include developing methods for various quality attributes for complex injectable drug products such as Liposomes and Ophthalmic Drug products. You will also be in charge of performing method validation and verification, as well as analyzing drug products using a variety of analytical techniques including HPLC, GC, UV, and other relevant methods. In addition, you will be tasked with identifying, investigating, and troubleshooting issues as they arise. Your responsibilities will also involve conducting chemical analyses such as Extraction, Refluxing, Residue on ignition, Centrifuging, and Evaporation. Furthermore, you will be expected to prepare study templates, analytical method validation and verification reports, as well as protocols to support your findings. Overall, this role will require a high level of attention to detail, strong analytical skills, and the ability to work effectively within a regulated pharmaceutical environment.,

Job description Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What you d gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelor s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Master s or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

You will be responsible for performing analyses of Drug Product and Drug Substances to evaluate various test parameters as per product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. Additionally, you will compile analytical results and prepare Method Development Reports. It is essential to ensure adherence to GLP aspects in the analytical laboratory to maintain quality and accuracy in testing processes. The ideal candidate should have 0 to 3 years of experience in a similar role.,

Food Tech -calibration ,maintenance and inter of LC-MS,GC-MS method validations and method verification for food and water samples, testing peptides, residue, antibiotics, water samples and water samples using GC-MSMS &LC-MSMS

The R&D Executive at PTC - MORAIYA will be responsible for performing analysis of Drug Product and Drug Substances for various test parameters according to product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. The role also involves compiling analytical results and preparing Method Development Reports. Additionally, the R&D Executive will be responsible for ensuring Good Laboratory Practices (GLP) aspects in the analytical laboratory. The ideal candidate should have 0 - 3 years of experience in a similar role.,

JOB DESCRIPTION (JD) Designation: Executive/Senior Executive Location: Gurugram Department Name: R&D Quality-CMC QA List of Responsibilities / Job Functions: Review of R&D documents such as stability data, Analytical reports, Method Qualification reports, Method verification reports, Method validation protocols & reports, Working Standard / Impurity Standard profile, analytical data of pilot bio batches and Method transfers protocol & report. Review of Lab event/Deviations/Change control/CAPA and associated investigation reports prior to Technology Transfer. Support and participate in f ailure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R&D sites. Visiting the AD Labs / Areas for verification of GDP & GMP compliance. Audit of Analytical Development department. Ensure the periodic activities as per the quality procedures are performed in a timely manner. Work in partnership with the site cross functions and corporate functions for Audit readiness. Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Perform other duties as assigned by Functional Head time to time. Review and approve the periodic activities as per the quality procedures. Support operations team during corporate audit/ external audits Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Review of Product development data and specification.

Stedman Pharmaceuticals is looking for a dynamic and experienced candidate for the Quality Control (QC) department with hands-on experience in Analytical Method Validation for various dosage forms. Resume to hrd@stedmanpharma.com / 9786920463

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.

Department: Quality Location: Kurla Travel: Low Job Overview: Remote support to PPL sites in reviewing analytical data remotely, preparing master build in LIMS (Lab Vantage / Labware), Document Preparation (specifications, test methods, protocols, etc.) and uploading for review in ensure, initiating QMS elements in Trackwise / eDMS. Key Stakeholders: Internal Site Quality Team (QC, QA), Corporate Functions Key Stakeholders: External Regulators (during inspection), Solution Providers Reporting Structure PPL Site Quality (Functionally) and CQA Document, Data Review & Creation (Administratively) Qualification B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology Experience Need to be ready to live and embrace the Piramal values. Quality professional with 8+ years of QC / QA experience in a regulated pharma companies. Must have hands-on experience in Laboratory software's, testing, applications and systems (Chromatography By HPLC and GC, UV, IR, Dissolution, Malvern, KF auto titrator, etc). Must have worked in LIMS for Data entry / master build, and data review. Knowledge of applicable regulatory requirements / regulations (USFDA, EU, Health Canada, others). Need to be aware of latest regulations and pharmacopeial requirements. Well-organized and committed, with strong verbal and written communication skills. Good Collaboration skills and Team player. Key Roles and Responsibilities: Preparation of Master Build in LIMS. Oversee track-wise operations for QMS activities. Preparation and review of Method Validation, Method Transfer, Method Verification, and Equivalency documents. Preparation and review of Test Methods, STPs, and Specifications. Operational knowledge of eDMS and ensure application compliance. Monitor compendial changes and prepare evaluation reports (including specifications and methods) for affected site products and materials. Review analytical data, raw data, chromatography, and LIMS for RM/PM/FP. Prepare and review new SOPs. Ensure timely completion of documentation. Maintain data integrity while preparing, uploading, or reviewing documents. Collaborate effectively across Piramal Plants. Provide support to any PPL site as required, with role assignments based on evolving needs and timelines. Perform activities across US, Canada, and EU time zones; available to travel for up to 3 months to PPL sites (India and overseas) as needed. Perform additional tasks as assigned by the Leadership team based on requirements Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology