356 Method Validation Jobs - Page 6

Role & Responsibilities Complete all assigned routine lab tasks Maintain proper documentation and records for lab analysis Perform method validations and submit raw data and job spreadsheets Send confirmed results and documents for report preparation Follow safety protocols in chemical and microbiology labs Be available to work additional hours or shifts as needed Key Results Areas (KRAs) & Key Deliverables Ensure complete documentation per Quality system standards Review and verify completeness of audit documentation Record actions as per lab requirements and specifications

Company Name: Oneiro Lifecare Pvt Ltd Location: Ekalbara Designation: QC Chemist/Officer/Sr Officer Job description (JD): Qualification: Masters (Chemistry) Candidate should have following criteria: 1] Experience of 1-6years in ADL / QC. 2] Handling instruments like HPLC and GC-Headspace. 3] Handling other analytical instruments like KF-Titrator, Auto-Titrator, pH-meter, Polarimeter, UV Spectrophotometer, Balance etc. 4] Analysis of In-process monitoring, Raw material, Intermediates, Stability studies and Drug substances (API). 5] Analytical method development and analytical method validation exposure. 6] Calibration of analytical instruments 7] Should follow GLP practices, Document preparation for Specifications, SOPs, Certificate of analysis and technical reports. Note: Candidate should be willing to work in shifts and across multiple locations as per organizational needs.

Job Description Summary The Regulatory Affairs Senior Associate is responsible for the preparation, compilation, evaluation and submission of ANDAs & Amendments to USFDA and handling deficiencies with timely submission of responses to agency. Job Description Coordinate with cross functional team/stakeholders (R&D, Quality, manufacturing, SCM, IP, PM) and vendors as required and evaluation of documents in-line with the current regulatory requirements Review of Product Development Report, Executed and Intended Batch Records, Specifications, Analytical Procedures, Method Validation Protocols and Reports & Certificate of Analysis of API / Excipients / In-Process / Finished products/Packaging materials, stability protocols and reports. Review of vendor documents of API, Excipients and Packing materials Review of documents for adequacy (w.r.t content, requirements, legibility, PDF requirements, etc.) Preparation, review and compilation of ANDAs, Amendments and Supplements in eCTD format. Coordinate with Regulatory Operation team member for uploading the submission in e CTD software Review of exported submission shared by Regulatory Operation team for submission . Monitor the FDA website for any updation. Education & Experience :- Master of Pharmacy in Dept. of Pharmaceutics Total experience of 3-5 Years in Regulatory Affairs

Proven Experience of working in GMP/GLP and scientific environment. Basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, peptide and peptide characterization (Expertise in any one of the subject). Experience in related compound method development and method validation for Peptide drug product using LC-UV and Amino acid analyzer. Hands on Experience of using SEC-UV SEC-MALS, SV-AUC, CE and data interpretation (Expertise in any one of the techniques and data interpretation). Experience in preparation and review of method development, method validation reports. Knowledge of ICH guidelines and regulatory requirement for peptide product. Team player. Willing to work at different job location as per the team requirement. knowledge of scientific writing will be plus.

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to align with organization goal and other responsibilities assigned by reporting authority. Responsible to perform the calibration of instrument and to maintain instrument/equipment as per SOPs. Responsible to follow safety precaution as per laboratory procedure. Responsible for method development studies of Drug Substance, Drug Product & In process Materials related to Peptides. Responsible for method Validation studies of Drug Substance, Drug Product & In process Materials related to Peptides. Responsible for analysis of routine samples and stability studies of Drug Product & In process Material Drug Substance, Drug Product & In process Materials related to Peptides. Responsible to prepare Study Protocol and Study Reports. Responsible for analysis of Oligonucleotides (DNA & RNA molecules) of single strand (Sense and Antisense) and Duplexes molecules. Responsible for Development of IEX and Ion Pair method for Sense and Antisense to separate charge variants in DNA and RNA molecules Responsible for Development of SEC method to separate size variants in DNA and RNA molecules. Responsible for Isolation of Peptide molecules from impurities by PREP HPLC.

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

About Us Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs. Job Roles & Responsibilities Analytical Method Development & Validation: Develop and optimize analytical methods for pharmaceutical compounds using HPLC, GC, UV-Vis, and other analytical techniques. Perform method validation studies including accuracy, precision, linearity, specificity, and robustness testing. Transfer analytical methods between laboratories and ensure successful implementation. Troubleshoot analytical methods and resolve technical issues. Sample Analysis & Testing: Conduct routine analysis of raw materials, intermediates, and finished pharmaceutical products. Perform quantitative and qualitative analysis following established protocols and regulatory guidelines. Execute stability studies and analyze samples at designated time points. Instrumentation & Maintenance: Operate and maintain analytical instruments including HPLC, GC, GC-MS, FTIR, UV-Vis spectrophotometers. Perform routine calibration. Troubleshoot instrument issues and coordinate with service technicians when needed. Ensure proper documentation of instrument performance and maintenance activities. Data Management & Reporting: Analyze and interpret analytical data using statistical methods and software. Prepare technical reports, certificates of analysis, and regulatory submissions. Maintain accurate laboratory records and electronic data systems. Knowledge & Experience Master's degree in Analytical Chemistry, Chemistry, or related field. 2 - 4 years of relevant experience in pharmaceutical, chemical, or analytical laboratory settings. Strong foundation in analytical chemistry principles and techniques. Preferred Qualifications Experience with advanced analytical techniques (DSC, TGA). Previous experience in pharmaceutical or biotech industry. Understanding of stability testing and forced degradation studies. Knowledge of cleaning validation by UV / HPLC. Why Join MPDRPL? Be part of an organization driving cost-effective global healthcare solutions . Work on end-to-end projects from concept to market. Collaborate with experts across departments in a quality-driven, innovation-centric environment . Access to modern formulation laboratories and pilot-scale facilities. Competitive compensation with performance-linked incentives . Professional development and career advancement opportunities . Comprehensive employee benefits including healthcare and retirement plans .

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file. Responsible to follow safety precaution as per laboratory procedure. Responsible to escalate any issue / incident to reporting manager for prompt corrective action. Responsible for method development studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for method Validation studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for routine and stability studies of API, Drug Product & In process Material preferably Peptide molecules Responsible to perform the pharmacopeial evaluation study as per requirement. Responsible to align with organization goal. Other responsibilities assigned by reporting authority. Responsible to follow Quality Management Document procedure. Responsible to perform the calibration of instrument. Responsible to prepare Study Protocol and Study Reports. Responsible to maintain instrument/equipment as per SOPs. Responsible for timely archival of documents as per SOP. Responsible to follow safety precaution as per laboratory procedure. Responsible to ensure proper Handling and Disposal of waste. Responsible to qualification reference standard / working standard/chemical reference standard samples as per approved and valid procedure.

Description: To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc.). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage. Performing qualification, periodic calibration, and maintenance of laboratory instruments. Maintain proper cleanliness, calibration, and qualification status of analytical instruments. Coordinate with warehouse and QA for sampling of incoming materials as per SOPs. Ensure proper labeling, storage, and disposal of samples and reference standards. Support internal, customer, and regulatory audits by providing required documentation and clarifications. Implement corrective and preventive actions (CAPA) as per audit observations. Additional Responsibilities: Participate in method validation, verification, and transfer activities as required. Assist in updating and reviewing SOPs, specifications, and analytical procedures. Contribute to continuous improvement initiatives in the QC department. Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor. Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Act as Senior Analyst in Bioanalytical Biosimilar Department Department : Bioanalytical- Proteins & Biosimilars Designation: Executive Location : - Ahmedabad Education : M.SC Biotechnology/ Biochemistry Experience: 4-6 yrs. CTC range : 8-10 Lac/annum Job description: Act as a Senior analyst for method validation and studies for LBA PK methods. Candidate has ability to develop and validate of LBA based bioanalytical PK methods and handling of 2 Project/MV activity together with 2-3 analyst team. Analyze serum samples clinical studies as per respective draft/method SOPs. Independent execution of ELISA / ligand binding assays, Collate, analyze and interpret data. Troubleshoot technical challenges during conduct of MD/MV/Projects. Review or prepare Method SOPs, BA-PBS SOPs, Study Plans, Analytical Reports and Validation Reports. Assist in reconciliation of study or MV raw data, Respond to QA and QC communications for in study or in process audits. Management of inventory for critical reagents or study specific general reagents. COMPETENCIES Accountability Communication Work Ethic Organizational Culture fit Initiative

Role & responsibilities 1. Knowledge of calibration and operation of HPLC with empower software. 2. Sound knowledge of analytical method development and Analytical method validation of OVI, purity, and assay method by HPLC as per pharma guidelines. 3. Knowledge of caliberation and operations of all equipments like balance, ph meter, in analytical opeartion. 4. good knowledge of sample preperation as per GLP. 5. Knowledge of retreival and storage working standards and columns. 6. Handling of final compilation of raw data, chromatographic data complying with GLP requirements. 7. Recording all analytical activities, approximately in respective raw data forms. 8. knowledge of preperation of general lab SOPs and instrument sops. Desired candidate profile: 1. Must have worked in method validation, ADL, analytical lab. 2, Knowledge of HPLC,

HPLC Analysis Method Validations Method Developments. Calibrations. Forced Degradation Studies Required Candidate profile HPLC Analysis

Regular Batch Analysis by using LCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS

Role & responsibilities 1. Knowledge of calibration and operation of HPLC with empower software. 2. Sound knowledge of analytical method development and Analytical method validation of OVI, purity, and assay method by HPLC as per pharma guidelines. 3. Knowledge of caliberation and operations of all equipments like balance, ph meter, in analytical opeartion. 4. good knowledge of sample preperation as per GLP. 5. Knowledge of retreival and storage working standards and columns. 6. Handling of final compilation of raw data, chromatographic data complying with GLP requirements. 7. Recording all analytical activities, approximately in respective raw data forms. 8. knowledge of preperation of general lab SOPs and instrument sops. Desired candidate profile: 1. Must have worked in method validation, ADL, analytical lab. 2, Knowledge of HPLC,

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 05-07-2025. 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 : 05-07-2025 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

Sterility, bioburden, endotoxin, AET/PET testing Method validation for medical & polymer products Lab setup, media prep, equipment handling Water (WFI/CS) & environmental monitoring Data review as per cGMP & compliance norms and Maintain lab records

Dear All, We are looking for Nitrosamine exposure candidates who are having an experience of 3-5 Years into the industry. Responsibilities: Lead method development and validation for trace-level detection of nitrosamines and NDSRIs using advanced instrumentation (GC-MS/MS, LC-MS/MS). Perform root cause analysis and establish robust impurity control strategies based on analytical data and scientific rationale. Prepare and review method validation protocols, risk assessment reports, and regulatory documentation for nitrosamine-related investigations. Interpret analytical data in compliance with GLP, ICH guidelines, and regulatory agency expectations. Drive nitrosamine risk assessments for APIs, excipients and finished dosage forms in collaboration with cross-functional teams. Stay up to date with evolving international regulations and scientific guidance on nitrosamine impurities. Provide technical support during regulatory inspections, audits, and client reviews. Mentor junior analysts and contribute to continuous improvement initiatives in laboratory practices. Note: Interested candidates can share their updated resume to sonyjeevitha.degala@aizant.com

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Analytical method development of API and intermediate. Handling of HPLC, GC, Karlfisher, potentiometry titration. Preparation of specification and STP. Titration expertise. Daily work reporting, literature search and trouble shooting in QC Labs. Required Candidate profile Must worked in ADL department of API industry for at least 5 Years. Perks and benefits PF Transportation Canteen

Walk-In Drive For API Analytical Research & Development(AR&D)- MSN Laboratories, Pashamylaram, R&D center on Saturday 05-07-2024. Requirement for Executive / Senior Executive - API AR&D - API Analytical Research & Development(AR&D) HPLC,GC,GCMS,LCMS,PXRD High performance liquid chromatography (HPLC) & GC HPLC with Software lab solu. UV-VIS Spectrometer GC with Software lab solution PH-Meter Moisture Analyser Karl Fischer titrator Micro- Weighter Balance Responsible for an Analytical team involved in Method development, Method Transfer and Validation for various stages of drug development. Method Validation of analytical methods as per internal and country specific regulatory guidelines and execution through proper protocols. Compliance of Good Laboratory Practice in the lab Responsible for providing support to technical issues related to R&D to file the Drug Master files. Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development. Responsible for ensuring delivery time-lines and adherence to quality and standards and customer Relationship management. Facilitating scientific and technical discussions with team members and external collaborators to resolve issues and communicating conclusions from stability studies. Interview Date : Saturday 05-07-2024 Department : Analytical Research & Development(API AR&D) HPLC,GC,GCMS,LCMS,PXRD Experience : 1 to 6 Years Qualification : M.Sc Position: Executive / Senior Executive Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue Details :Venue Details : MSN Laboratories Pvt. Ltd, R&D Centre, Pashamylaram (V), Patancheru (M), Sangareddy (D.t), Telangana