489 Method Validation Jobs - Page 16

Responsible for developing the cell based assays and conduct routine screening. Expert knowledge/skill sets in cell culture, biochemical and cell based assays, animal tissue samples. Analytical techniques : Cell culture, ELISA, flow-cytometry, Confocal microscopy, animal Industry - Pharma / Biotech / Clinical Research Functional Area - RD, Pharmaceuticals, Biotechnology Role Category - Research Scientist Desired Profile PG - M.Sc - Bio-Chemistry, Microbiology, M.Tech - Bio-Chemistry / Bio- Technology.

Role & responsibilities 01 Quality Control Functions: 1.1 To ensure that the laboratory carrying out its testing, calibration, validation and all other technical activities in such a way to meet GLP requirements. 1.2 To carry out all technical activities and implementation of documented quality system. 1.3 To plan, schedule and monitor analysis of Raw Materials, Premix, Packing Materials, In-process materials, Finished products, Microbiological analysis, Water analysis and ensure that they meet defined relevant quality standards. 1.4 Periodically review logbooks, reports and test protocols related to Raw Materials, Premix, Packing Materials, Microbiological analysis, In-process and Finished ...

The selected candidate will work directly in a private setup focused on stock and commodity trding in a residential setup with free accommodation. This role is ideal for someone who is looking for a long-term, stable opportunity. Free meal Cafeteria Food allowance Shift allowance Over time allowance House rent allowance Flexi working Accessible workspace Assistive technologies Sports for women

Candidate must have experience from chemical manufactiring industry.

Find endless opportunities to solve our clients toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Strategy & Consulting, Global Network I Areas of Work: Cost takeout, earnings before interest, taxes, depreciation, and amortization, (EBITDA) improvement in Direct Spend | Level:Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad| Years of Exp:4-8 years for Consultant, 1-4 years for Analyst Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment...

Provide remote analytical support to PPL sites, including review of analytical data and preparation of documents such as specifications, test methods, and protocols. Upload documents for review in ENSURE and initiate QMS elements in TrackWise/eDMS. Prepare and review stability protocols and reports, and perform stability data trending and analysis B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Review of analytical data generated in the analytical lab (QC/AS) including but not limited to Cleaning verification data, IPC , raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a t...

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 safe...

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...

Role & responsibilities : Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables) Daily calibration of pH meters, balances etc. Stability sample management (loading & withdrawal as per stability plan) Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicable Hands-on experience of analytical instrumental techniques (HPLC with chromatographic software etc.) Assisting analytical method development/validation/method transfer activities, as per need Supporting other assigned lab responsibilities for GLP compliance Preferred candidate profile

Analysis of in-process, raw materials, intermediates API with expertise on HPLC and wet chemistry. To carry out analytical method development and method validation, in-process samples and finished products. To carry out analytical method transfer activity to QC. Trouble shooting of analytical instruments for difficulties faced during day-to-day operations. Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc. Literature Search for development of analytical methods. To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practice...

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 cry...

We have opening for Formulation AR&D Department. Job Openings: 6 Nos Position : Research Analyst or Sr Research Analyst Handling Instruments like HPLC 1-5 Years Exp 2- 8 Yrs. Job Location: Pashamylaram - Patancheruv (Telangana) Salary : As Per Company Norms Qualification: Pharm or M.Sc. or M .Pharm 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 ...

Over see the development, implementation, and validation of analytical methods used for the testing of Active Pharmaceutical Ingredients (APIs) in compliance with internal standards, industry regulations, and customer requirements. The role requires leadership skills to manage a team, ensure compliance with good laboratory practices (GLP), and drive continuous improvement in method validation processes. This position also involves close collaboration with various cross-functional teams including R&D, Regulatory Affairs, and Quality Assurance.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Greeting from Biophore India pharmaceutical Pvt Ltd. Hiring for Formulation Analytical R&D Department. Job Openings: 6 Nos Position : Research Analyst or Sr. Research Analyst Exp 2 - 7 Yrs. Job Location: Pashamylaram - Patancheruv -Hyderabad. Salary : As Per Company Norms Qualification: M .Pharma or M Sc or B.Pharm 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 Me...

Greeting from Biophore India pharmaceutical Pvt Ltd. Hiring for Formulation Analytical R&D Department. Position : Research Analyst or Sr. Research Analyst Exp 2 - 7 Yrs. Job Location: Pashamylaram - Patancheruv -Hyderabad. Salary : As Per Company Norms Qualification: M .Pharma or M Sc or B.Pharm 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 act...

Method development and validation of Genotoxic impurities/ nitroso amine impurities/NDSRIs in pharmaceutical products/ substances by LC-MS/MS. Development of MS compatible methods for the HPLC RS methods for the identification of unknown peaks by LC-MS Development of MS compatible methods for the identification of degradation impurities and unknown impurities

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Role & responsibilities 1. generate sample run list from the laboratory's information management system (LIMS). 2. Set up the LCMS system for sample analysis and run samples according to defined methods. Documents activity according to company sops. 3. Process and review instrument data and document all observations according to company sops. 4. Update data into Laboratory's LIMS. 5. Prepare reagents required for routine analysis. 6. Write or contribute to the review of written SOPs in the laboratory. 7. Understand and comply with all safety procedures applicable to the type of work performed. 8. Work with all laboratory personnel to maintain a safe and clean working environment. 9. Work wit...

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and...

Develop analytical methods for biochemistry samples using GC-MS, LC-MS, and other relevant techniques. method validation, optimization, and transfer to ensure accuracy and reliability of results. data analysis, and reporting in accordance .

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Physical R&D Researcher I - TAPI Date: May 2, 2025 Location: Greater Noida, India, 201306 Company: Teva Pharmaceuticals Job Id: 61663 Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industrys broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead t...

Qualifications: Educational Background: M.Sc. in Chemistry, Pharmaceutical Chemistry, or related field. M.Pharm in Pharmaceutical Analysis is a plus. Experience: 38 years of experience in analytical development within the pharmaceutical industry. Technical Skills: Proficiency in analytical techniques such as HPLC, UV-Vis spectroscopy, and dissolution testing. Familiarity with method validation and stability study protocols. Soft Skills: Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Ability to work independently and in a team-oriented environment.

Oversee and execute analytical testing of raw materials, in-process samples, and finished products. Ensure compliance with cGMP, GLP, and regulatory guidelines. Review and approve analytical data, test results, and documentation. Troubleshoot analytical instruments like HPLC, GC, UV, and FTIR. Support method validation, stability studies, and regulatory audits. Implement quality improvement initiatives and ensure data integrity

Role & responsibilities 1. Performing Stability analysis, Method transfer and Method Validation. 2. Develop formulations for solid oral dosage forms (Tablets, Capsules) with expertise in compression, granulation, coating, OSD, and formulation development. 3. Conduct production monitoring activities to ensure compliance with quality standards. Desired Candidate Profile 4. Strong understanding of tablets, capsules, compression, granulation, coating processes; knowledge of OSD technology an added advantage. 5. Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports. 6. To carry out analytical method development, method validati...