483 Method Validation Jobs - Page 11

Role & Responsibilities: Complete all of the routine tasks that have been allocated Retain paperwork and records as required by lab analysis Finish required method validations and transmit job spreadsheets, raw data, and supporting documentation Once results are confirmed, send documents to appropriate teams for report production Follow laboratory safety protocols in chemical and microbiological laboratories Be willing to work extra hours or shifts Complete documentation per the Quality system standards Review audit documentation and ensure completeness Record actions according to laboratory specifications Have a thorough understanding of chemical analyses in test techniques Apply chemistry,...

Role & Responsibilities Complete all routine lab tasks as assigned Maintain records and paperwork required for lab analysis Perform method validations and submit job spreadsheets, raw data, and supporting documents Forward confirmed results for report preparation Follow laboratory safety protocols in chemical and microbiology labs Work flexible hours or additional shifts when required Ensure documentation aligns with Quality System standards Review audit documentation for completeness Record activities as per lab specifications Required Competencies Understanding of microbiological analysis techniques as per test procedures Experience in microbiology and biochemistry testing for food, water,...

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 preparat...

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 mat...

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 ...

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 Dr...

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...

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...

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,...

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/annu...

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 gene...

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 gene...

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...

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...

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