835 Method Validation Jobs

ql-editor "> Research Scientist The Analyst will be responsible for supporting bioanalytical studies within the clinical research domain, with a focus on method development, method validation, and routine sample analysis. The role requires strong technical expertise and adherence to established quality and regulatory standards. The selected candidate will actively contribute to the execution of bioanalytical projects in full compliance with GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and all applicable regulatory guidelines. The Analysts will additionally be responsible for providing supervisory support, guiding junior team members, and taking on broader project leadershi...

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of ho...

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of ho...

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of ho...

Role & responsibilities : Reviewing, verifying, and processing of all technical documents for accuracy before compilation or submission of dossiers as per USFDA & PEPFAR requirements. Review and regulatory compliance of Initial ANDA Documents like Trade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Size and Shape, Elemental iron, Residual solvent, Elemental impurity and Exactable and Leachable impurity, Specifications [API and Finished drug Product), Master Formula (with respect to Bio-waiver), Stability Protocol, Labeling Information, Product development Report, Method Validation Report, BMR and BPR etc. Participate and represent as regulatory team in meetings (Level 1 and 2 ...

Role Overview: As a Quality Specialist II at Teva Pharmaceuticals, you will play a crucial role in ensuring that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner. Your responsibilities will include compiling high-quality APRs/PQRs, liaising with third-party contract manufacturers for data collection, recommending actions for continuous improvement in product quality, and participating in various quality management systems activities. Key Responsibilities: - Compile high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at different sites - Retrieve data from Quality and regulat...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Primary Responsibility: Pre-sales demonstration with applications for high end technology (LCMS and LCMSMS) Post-Sales training to customer trouble shooting at customer place as well as in Technical Centre to support LSMS sales team (30-50%) Technical Training sessions for Customer as well as internal customers. Help to maintain and increase product usage and support sales efforts through technical presentations and product demonstration. Develop and maintain positive relationship with customers. Accompany Sales Representatives on sales calls in customer laboratories to provide technical and applications assista...

Responsible for lab functions-QC,Analytical & Application, RM/PM/Inprocess/FP testing & Analysis, Checking & review of QC SOPs/STPs, cGMP, Handling/Calibration/troubleshooting of Lab instruments, system Devlp,Co-ordn with Prod/SCM/R&D/QA Dept,MIS etc Required Candidate profile M.Sc./M.Pharm with 11 to 16 yrs exp in API industry. Should have sound exp of handling HPLC, GC, KF, AT, LOD tester, MP/BP,Polarimeter etc. System knowledge like IMS, GMP, NABL RC, SAP, ISO is must.

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 Saturday 06-12-2025. 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, w...

Role & responsibilities : HPLC monitoring and handling Inspection and testing Equipment operation Perform analytical testing Operate and maintain instruments Handle data and documentation Support stability studies Report and investigate Out of Specification (OOS), Out of Trend (OOT) results, and deviations. Manage lab supplies Ensure compliance Environmental monitoring Testing and analysis Strong knowledge of microbiology principles and testing methodologies Proficiency with microbiology laboratory equipment.

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 06-12-2025. 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...

Ensure compliance for audit of QC as per USFDA, EU GMP GLP in QC Calibration Review of all QC Standards & Procedures regarding Calibration, Raw and Packing Material, Finished products Excellent communication & coordination Required Candidate profile B.Pharma / M.Pharma/ M.Sc with 7 to 20 years experience as QC reviewer, ensuring compliance as per USFDA & EU GMP standards Capable to Review of all QC procedures Willing to relocate to Jaipur

Role & Responsibilities Lead development of device coatings with and without drug-eluting capability for medical applications. Formulate and optimize polymer matrices for device coating and for controlled release from device coatings. Design and synthesize sodium-based and acid etching solutions for surface treatment and functionalization. Develop surface modifying reagents tailored for L-605, Nitinol, and other medical-grade alloys. Oversee wet chemistry lab setup including equipment specification, layout, and compliance setup. Establish lab SOPs and ensure strict adherence to EH&S and GLP standards. Plan and execute in vitro drug release studies, stability protocols, and surface characteri...

Role & responsibilities We are looking fresher candidate Preferred candidate profile Male candidate

Role & responsibilities Routine analysis using HPLC and GC independently Method execution, system suitability, and troubleshooting Analysis of RM/Intermediates/Finished Products Calibration & maintenance of HPLC/GC instruments Review of chromatographic data, audit readiness, and documentation Preparation of COA, STPs, and analytical records Ensuring strict compliance to cGMP and data integrity Preferred candidate profile 3+ years QC experience in an API manufacturing unit Strong hands-on expertise with HPLC & GC (operation, troubleshooting, calibration) Good understanding of ICH Q2 , cGMP, and data integrity principles Experience in routine analysis of RM/Intermediates/Finished Products Abil...

Dear Candidate, Greetings from SGS India Pvt. Ltd.! We are actively looking for Chemist Role at our Kopar Khairane Lab. We are conducting a Walk-IN Interviews on 29th November 2025 (Saturday) between 10AM to 4PM. Brief Job Description : To perform E&L and nitrosamine testing and other analytical activities like method development and method validation on instruments like LCMS, HRMS, IC and GCMS. Documentation as per GMP requirement. Adhere to SOPs of SGS while performing the activities. Deliver the projects as per commitment to the clients. Interested Candidate can share updated CV on fleur.dsouza@sgs.com Venue Details: Address - Plot No. A-772/ A-773, MIDC, TTC Industrial Area, Kopar Khaira...

Job Description We are seeking an experienced analytical scientist to support method development, validation, and technology transfer activities for pharmaceutical products. The role involves close collaboration with chemical research teams and production sites to ensure analytical excellence and regulatory compliance. Key Responsibilities: Develop analytical methods for in-process materials, raw materials, intermediates, and finished products Conduct carryover studies for reagents and genotoxic impurities Perform method validation, equipment cleaning validation, and stability analysis Characterize and isolate impurities and support technology transfer to production Prepare specifications, s...

Walk-In Drive for Formulation Scientists (OSD) - EU Market Date: November 22, 2025 (Saturday) Venue: APL Research Centre - I, Sy. No. 313, Bachupally, Hyd - 90 (Landmark: Aurobindo Pharma Unit-III ) Formulation Development Scientists (FRD): Hiring for M.Pharm candidates with 3-8 years of experience in development of OSD Products for Europe (EU) market along with exposure to plant scale up activities. Formulation Analytical Research & Development (FARD): M.Pharm / M.Sc candidates with 3-8 years of experience in Analytical Method Development, Method Validation and Routine Analysis of OSD products for Europe (EU) Market.

Develop & validate analytical methods using HPLC, UPLC, GC, UV-Vis, IR Method transfer/verification. Routine & non-routine analysis of raw materials, intermediates. Stability samples under cGMP/GLP, OOS/OOT investigation.

Role & Responsibilities: : Conduct bioanalytical research activities such as method development, validation, and sample analysis using techniques like HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. Develop and validate methods for bioanalysis of biologics and biosimilars according to regulatory requirements (e.g., USFDA). Collaborate with cross-functional teams to ensure timely delivery of high-quality results. Perform stability testing of biological products under various conditions. Troubleshoot issues related to instrument calibration, maintenance, and operation. Desired Candidate Profile - Strong understanding of analytical instruments such as HPLC/UPLC/...

Job Overview: We are seeking a Lab Attendant to support our Chemical R&D team. The ideal candidate should have average to above-average knowledge of chemistry, willingness to learn, and passable communication skills. Key Responsibilities: Assist in routine lab operations, sample preparation, and testing. Maintain cleanliness, safety, and order in the lab. Support researchers with experiments and basic chemical handling. Ensure proper storage, labeling, and disposal of chemicals. Record and update experimental data as directed. Requirements: B.Sc. / M.Sc. in Chemistry (preferred). 01 year of experience in a lab environment. Basic understanding of chemical processes and lab practices. Ability ...

As an Analyst for the Small Molecule Bioanalytical Laboratory at Syngene International Ltd., your primary role involves conducting BA/BE studies in the laboratory. You will be responsible for critical method development and validation programs, ensuring technical and regulatory compliance of all studies. Your background in pharmaceutics or related life sciences, along with extensive experience in the bioanalytical field, particularly in small molecule bioanalysis, will be crucial for success in this role. Your commitment to compliance, integrity, and excellence in bioanalytical research, specifically in small molecule analysis, is highly valued. Key Responsibilities: - Perform bioanalytical ...

Date: 10 Nov 2025 Location: Bangalore, KA, IN, 560099 Division: Dedicated Centre Job Description Job Role : Analytical QA analyst Department : Quality Assurance BGRC Job Location : Bangalore 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. Mandatory expectation f...

Key Responsibilities: Develop and optimize analytical methods for APIs using techniques such as HPLC, GC, UV-Vis, FTIR, and titration. Perform method validation as per ICH guidelines (specificity, linearity, accuracy, precision, robustness, etc.) Responsible for analytical method development and method transfers to preparative HPLC. Conducted analysis of compounds to determine chemical and physical properties, composition and structure utilizing chromatography, spectroscopy and spectrophotometry techniques including but not limited to HPLC/UPLC. Prepare and review method development and validation protocols and reports. Conduct forced degradation and stability-indicating studies. Support tec...

The successful candidate will be responsible for designing, developing, and optimizing OSD formulations, ensuring product quality, stability, and performance. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Food allowance Health insurance Office cab/shuttle Provident fund