489 Method Validation Jobs - Page 19

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 rout...

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 ...

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...

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 d...

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 p...

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 s...

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 compl...

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 ...

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 kn...

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 performi...

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.

Key Responsibilities Perform analytical testing of raw materials, intermediates, and finished APIs using HPLC, GC, UV, and other analytical instruments. Execute analytical method validation, method transfer, and verification as per regulatory guidelines. Ensure compliance with cGMP, GLP, and regulatory standards (ICH, USFDA, EU, WHO) . Maintain accurate documentation, calibration logs, and test reports in compliance with company SOPs. Support investigations, OOS, OOT, and CAPA implementation . Coordinate with QA and Production teams for smooth project execution. Contribute to laboratory upkeep, safety practices, and audit readiness.

Role & responsibilities Execute Analytical method Validation activities of drug substances (API) by using HPLC,GC and Spectroscopic techniques as per regulatory guidelines Execution and coordination for Analytical method transfer activities of drug substances(API) Calibration of the Analytical instruments as per the master calibration schedule. Preparation and review of analytical protocols and reports (Analytical Method Validation). Handling of Laboratory investigations like OOS,OOT,Incidents,deviation etc

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- Holi Child School, Near Dundigal Police Station, Gandi Maisamma on Friday 22-08-2025. 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 ab...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- Qualychrome Research Labs, H.No .5-5-35/128, plot no.177, near Venkateswara Swamy temple, Prashanti Nagar, Kukatpally, Hyderabad, Telangana on Friday 22-08-2025. 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, wit...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 22-08-2025. 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 i...

Job Responsibilities: A) Project Management Undertake on-going referencing and literature reviews and provide strategic inputs to projects at all stages Evaluate methods under consideration by conducting literature survey (incl. regulatory guidelines, pharmacopeia guidelines, publicly available research, etc.) Identify initial cell-lines/ anti-body requirement based on method(s) identified Conduct lab experiments for bio-assay/ immuno-assay development and optimization Conduct lab experiments to qualify the method for reproducibility Prepare/provide inputs for the preparation of necessary documents like Method development report, Method qualification protocol and report. Method validation pr...

What you will do - This role intends to recruit a talent who will seat on the divisional team and will have responsibilities for making testing efforts and goals a success working with local and global test lab Drive consistency in terms divisional procedures, be an active contributor in making development/verification testing a success. Responsible for sign off on key deliverable from testing/test lab perspective. Example: protocols, reports etc Ensure continual improvement in capability building , quality, delivering higher value services. Learn and contribute In making overall R&D process efficient by bringing predictability in terms of plan, execution, budgeting of development/verificati...

Conduct Extractables & Leachable studies Operate LC-MS/MS, GC-MS/MS, UHPLC, GC-FID Method development, validation & data interpretation Ensure GLP, NABL, 21 CFR Part 11 compliance Exp. in PFAS, BPA, Nitrosamines preferred MSc/M.Pharm/Biotech required

Role & responsibilities 1. Development of Analytical methods. 2. Validation of Analytical methods. 3. Preparing analytical method development reports. 4. Literature survey for existing analytical methods. 5. Carry out literature survey by establishing the strategies. 6. Maintenance of FDA department. 7. Coordinating various development activities in FDA laboratory. 8. Maintenance of reference standard, working standards and their standardization. 9. Co-ordinating the activities in Chemical and Instrumentation. 10. Analytical Method Development and handling of Troubleshooting. Preferred candidate profile M.Sc. - Analytical / Organic Chemistry Candidate from Vadodara or nearby location preferr...

Candidates should have good hands on Experience on HPLC, GC, Stability, Wet Lab, RM Sampling & Analysis, Documentation, Standardization of Karl fisher Titrator. Responsible for Calibration of Instruments. Can handle QMS & AMV activities Required Candidate profile Preferred immediate Joiners. USFDA preferable. Interested candidate can share CV on sachin.kapte@enaltec.com Mob.8976826875

Role & responsibilities Execute Analytical method Validation activities of drug substances (API) by using HPLC,GC and Spectroscopic techniques as per regulatory guidelines Execution and coordination for Analytical method transfer activities of drug substances(API) Calibration of the Analytical instruments as per the master calibration schedule. Preparation and review of analytical protocols and reports (Analytical Method Validation). Handling of Laboratory investigations like OOS,OOT,Incidents,deviation etc