746 Method Validation Jobs - Page 6

Executive for Micro R&D 1 Post based in Amritsar. The ideal candidate brings 6 - 8 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead...

The ideal candidate brings 1-6 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility assur...

oversee l operations and quality systems in a regulated CRO environment. ensuring microbiological data integrity, method development/validation, audit , and compliance (e.g., GLP, GMP, GCLP, ISO). Lead a team of microbiologists and QA personnel,

As a Sr. Manager - Micro Lead at Sun Pharmaceutical Industries Ltd in Ahmednagar, your role is crucial in overseeing the activities in Microbiology department. **Key Responsibilities:** - Planning, reviewing, and monitoring overall activities in Microbiology department - Coordinating with other departments to prioritize tasks and provide timely support/testing to avoid delays - Reviewing all departmental documents and results in LIMS system, ensuring completeness on time - Reviewing lysate sensitivity test, Bacterial endotoxin test of WFI and API products - Checking method validation of bacterial endotoxin test and microbial quality of products - Procuring, receiving, storing, maintaining, a...

As Manager - Office of Data Reliability at Sun Pharmaceutical Industries Ltd, your role involves critically reviewing data and documents from Analytical Research and Product/Packaging development departments for submission to USFDA. Your responsibilities include: - Perform a thorough review of raw data related to R&D activities such as Analytical Method Validations, Analytical reports, and Product Development Reports to ensure accuracy and integrity for regulatory submission. - Review supporting documents like user log books and electronic data related to USFDA submission. - Ensure compliance with employee Certification for all R&D data intended for USFDA submission. - Coordinate with stakeh...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Job Title Manager / Sr.Manager Micro Lead Job Grade G10 / G9B Function Global API Business Sub-function Manager's Job Title: Skip Level Manager's Title Function Head Title: Location: Ahmednagar No. of Direct Reports (if any) Areas of Responsibility To plan, review and monitor overall activities in Microbiology and lead the department. Co-ordination with other departments for priorities and provide the timely support/testing to avoid delay due to analysis. Review of all departmental related documents and review results in LIMS system in microbiology section. Ensure all documents are complete in time. To review the lysate sensitivity test, Bacterial endotoxin test of WFI and API products. To c...

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...

Walk-In Drive For API Analytical Research & Development(AR&D)- MSN Laboratories, Pashamylaram, R&D center on Wednesday 08-10-2025. Requirement for Executive / Senior Executive - API AR&D - API Analytical Research & Development(AR&D) HPLC,LCMS,GC,GCMS,PXRD High performance liquid chromatography HPLC,LCMS,GCMS,PXRD 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 guideli...

Roles & Responsibilities for Analyst 1. Understanding and maintenance of Quality Management System. 2. Performing the analysis as per the guidelines under supervision of Senior Analyst/ Lab manager. 3. Instrument operation and calibration on regular interval for Analytical balance, pH meter, HPLC, LCMS, etc. 4. Maintenance of the technical records, certificate of analysis as per requirement. 5. Recording Initial observations, necessary data, and calculations. 6. Inform the lab manager for any kind of equipment breakdown, fault or any kind of irrelevant test results (Preventive maintenance). 7. Perform method development, method validation and project related activities as per SOP/ Protocol. ...

Oversee Quality Control for API manufacturing, ensuring GLP, GMP, and regulatory compliance. Lead QC team, manage validations, audits, stability studies, and documentation from raw material to finished product with focus on quality excellence.

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

Key Skills / Knowledge Required The ideal candidate must have hands-on working knowledge and experience in the following areas: Chromatography: Expertise in operating and troubleshooting HPLC (High-Performance Liquid Chromatography) and GC (Gas Chromatography) . Testing: In-depth knowledge of IP/FP (In-Process/Finished Product) testing and analysis. Dissolution: Proven experience in performing and interpreting Dissolution studies for pharmaceutical formulations. Stability Studies: Experience in executing and managing Stability Studies as per regulatory guidelines. Documentation: Strong understanding of Good Laboratory Practices (GLP) and compliance requirements.

Role Description: We are seeking an individual who thrives in ambiguity, capable of shaping driving end-to-end process excellence and performance management with speed and precision. In this vital role, you will serve as the Performance Management Lead. Reporting to the Process Mgmt., E2E Policies, & Performance Lead, you will be support the designing and driving the deployment of a global strategy for procurement processes, defining and implementing best-in-class practices, and delivering processes and technology that align with channel and category strategies. This role plays a critical part in ensuring efficient, cost-effective, and compliant requisition-to-order transactions while mainta...

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical a...

Walk-in drive: Senior Chemist / Junior Research Associate - HPLC Analytical Method Validations Work Location: Hyderabad Eligibility: Must have 1 to 3 Years of experience in Analytical Method Validations by using HPLC for Formulation products. M.Sc. / M-Pharmacy or Equivalent Qualification. Job Description : Analytical method validations and method transfer as per cGMP requirements for drug products. Strong experience in handling various analytical instruments like HPLC, UPLC, UV and Dissolution USP type-I and II and type-IV. Dissolution, Assay and Related Substances method validationand method development of finished products like Tablets, Capsules, Pellets, oral suspensions and Injectables ...

About the Function: Our Supply Chain and Manufacturing team are problem-solvers, sourcing, producing, and delivering our much-loved brands to delight customers around the globe. Over half of Diageos 30,000+ people work in Supply Chain and Manufacturing. Its an intricate and sophisticated operation thats the product of logistical, manufacturing, and technical collaborations. Our teams in 100 sites in over 30 countries cover production facilities, supplier relationships, customer collaborations and third-party agreements. Were committed to realising our Society 2030: Spirit of Progress goals, to protect the environment and support our farmers and suppliers. Whatever your skills and experience,...

Dear Applicants, Greetings from Biophore India !! We have opening for Formulation AR&D Department. Experience : 2 - 6 Years Qualification : B. Pharm /M. Pharm or M Sc Work Location: R&D Centre -Pashamylaram, Isnapur, Sanga Reddy. Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative me...

As a candidate for this position, you will be responsible for conducting QC tests of raw materials, semi-finished, and finished products to ensure compliance with FDA, GMP, ISO, and other cosmetic industry regulations. You will be expected to perform microbiological, pH testing, and thermal stability testing on cosmetic formulations and should be familiar with lab equipment. Additionally, you will investigate quality deviations, defects, and complaints, ensuring corrective actions are taken. Collaboration with R&D, Production, and Regulatory teams will be essential to maintain quality standards. You will also be responsible for maintaining product batch QC release, COA approvals, SOPs, metho...

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 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...

Role & responsibilities Use of HPLC/GC/UV/Dissolution apparatus. Integration for Assay and RS. Method development and force degradation study for FP and API. Preparation of method development protocol. Dissolution development and impurity profiling. Force degradation study for FP and API. Pharmacopeia method interpretation, Literature/references search. Listing the requirements for method development. Review and interpretation of development trial data. Preparation and review of method development protocol and report. Descriptive method right up.

Job Description Maintenance of GLP in the Laboratory Upkeep of Housekeeping in the Laboratory. Ensuring activity logs are maintained for all critical instruments /equipment’s. Timely preparation of Laboratory Documents. Timely review of analytical data generated in laboratory. Ensuring Analytical Technology transfer from transferring lab as per approved protocol. Review and approval of incident , out of specification ,out of trend report and approval of QC related activities. Involved in QAMS activities such as change control, CAPA , incidents, deviation etc. Approval of stability summery report. Timely review of Quality control procedures and initiation for up gradation of same. Compliance ...

Roles & 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 b...