611 Method Validation Jobs

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,

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...

Job Title Executive Analytical Development (Microbiology) Business Unit R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Method development, Method Valid...

Job Title Executive Innovative Projects Business Unit R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. JOB Description: - To Access Study Plan and Standard Operating Pro...

Role & responsibilities Please find below JD for position in Research & Development at Intas Plasma Fractionation Centre based in Ahmedabad dealing in Plasma Protein Products: - Characterization of plasma proteins by various physicochemical methods - Responsible for stability sample analysis by different methods and its data management - Analytical Method Qualification and Analytical Technology transfer - Method Development & Troubleshooting - Instruments Handling/ Techniques: SDS-Page , HPLC, GC, IEF and Western blot - Reference standard qualification, instrument & micropipette calibration - Responsible for document preparation/review of LPs, MOA, MQP, MQR,TTD and documentation of related a...

Roles and Responsibilities Develop new APIs through organic synthesis, method development, and optimization. Conduct literature reviews to stay updated on latest research trends and technologies. Ensure compliance with GMP guidelines during API manufacturing processes. Collaborate with cross-functional teams for product development, scale-up, and commercialization. Perform impurity analysis using techniques like NMR, DSC, etc. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Ph.D/Doctorate in Chemical Sciences from a recognized university. Strong expertise in areas such as API synthesis, organic chemistry, method development/validation/transfer/methodology. 9-14 years of exp...

Exp. in ARD/AMD of minimum -20 to 30 years Lead the development and validation of analytical methods Prepare and review technical documentation Drive analytical strategy in global or cross-functional project teams

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Biosys Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Dev...

We are looking for a Senior Chemist with hands-on experience in analytical method development and validation The candidate will be responsible for designing experiments, interpreting data, and working with cross-functional teams to support drug discovery and development programs

Key Responsibilities Perform method development using Liquid Chromatography (LC) , Gas Chromatography (GC) , and Mass Spectrometry Conduct routine and non-routine analysis of raw materials , intermediates , and finished products Ensure accurate and timely execution of analytical testing Maintain and troubleshoot analytical instruments including HPLC , GC , KF , and other relevant techniques Prepare and review analytical documentation in compliance with regulatory standards Utilize chromatographic software such as Empower for data acquisition and processing Collaborate with cross-functional teams to support product development and scale-up activities

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...