750 Method Validation Jobs - Page 24

Job Description Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instr...

Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method val...

Under general supervision of lab team leader, independently perform routine scientific research tasks using standard techniques, procedures and equipment. Adapt and optimize or develop new methods and procedures, actively contribute to technical solution finding process. Propose solutions and discuss with manager Show engineering and tech transfer proficiency Assist and support to R & D team and cross functional team in scale-up of new products technology Troubleshoot & or improve existing processes Summarize and document results in lab journal, prepare technical reports. Maintain clean working laboratory environment and suitable working equipment. Perform general lab assignments (e.g. raw m...

1.Good Communication skills, 2.Method Validation 3.Instrumentation knowledge of LCMS & GCMS Qualification :M.Sc(Oraganic Chemistry/Analytical Chemistry) / M.Pharma

Key Responsibilities: Perform analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs) as per approved specifications and SOPs. Operate and maintain analytical instruments like HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, etc. Review and verify analytical data and ensure proper documentation in line with cGMP and GLP guidelines. Prepare and standardize volumetric solutions and reagents. Carry out stability studies and maintain stability data as per ICH guidelines. Ensure timely calibration of laboratory instruments. Perform method validation/transfer activities as per regulatory and internal requirements. ...

Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API S...

Analyst Analysis of raw material, Drug substance (API), drug products by HPLC, GC, UV-Visible Spectrophotometer, IR, SOR Instruments and chemical analysis (wet lab). Calibration of laboratory Instrument like UV-Visible Spectrophotometer, Balances, pH meter, KF Titrator, etc., and Preparation and maintenance of volumetric solutions, buffers, etc Exposure of GMP / GLP / GDP in laboratory. Designation - Officer / Sr. Officer /Executive Experience : 02 - 07 years Must be having experience in API Reviewer Analytical method development and validation of raw material, in-process and finished products by HPLC, GC, Dissolution apparatus. Review of analytical method validation / verification protocols...

Job Description To have good knowledge about all microbiology testing. To initiate Change controls, deviations and CAPAs related to Microbiology. To prepare and review the Microbiology related documents SOPs /EOPs/ GTPs/STPs, Validation / Qualification / Re-qualification , QRM, URS etc. To monitor the Sample invert and online documents. To prepare and execute IQ/OQ/PQ of the new equipment installed. To prepare method validation protocol and report. To ensure online and accurate recording of all cGMP records at Microbiology section and to follow cGMP practices. To ensure the all-time readiness for Internal and External Audits. To ensure the timely completion of AMCs and PMs. Work Experience 7...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compli...

"1) Responsible for Laboratory execution of analytical activities on daily basis and ensuring compliance to the Safety and quality system as per cGMP. 2) Responsible for Laboratory execution of instrument calibration, stability analysis, WRS preparation/Qualification and for procurement of reference standard etc. 3) Responsible for maintaining stock of working reference standards and chemicals required routinely for raw material analysis. 4) Review and release of finished product, inprocess, intermediates, raw material, reaction monitoring results. 5) Responsible for Laboratory execution of analytical method validation/Verification and Method Transfer activites. 6) Coordination for reagents ...

Responsibilities: * Develop analytical methods using HPLC & GC techniques * Ensure compliance with regulatory requirements during validation process * Collaborate with cross-functional teams on method implementation Provident fund Health insurance

Job Description Roles and Responsibilities: Lab Business set up as per testing requests, tender & contracts with customers, Marketing as per Testing facility available in lab, Man power adjustment, Authorisation of SOP, Method Development & Method Validation, Standard Regulation comply with as per norms, Training program arrangement-Plan & impart Technical & Quality related Training to the staffs, evaluate & maintain, Authorisation of Test Reports, Take action for the purchase of consumables, spares of Instruments, chemicals, CRMs, Standards etc., Monitoring & supervising overall activity of the designed lab Experience/ Knowledge Have proper knowledge of water/ waste water/ Textile & Dye/ Ch...

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation Development Quality Assurance Department (Formulation) Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDRs, PDR’s, MFR’s and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External ...

Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate pro...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025. 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...

Role & 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 basi...

Qualifications required: Bachelors /Masters (2-10 Years of experience in Bioanalytical Department only) Role and responsibility: 1. To work on the method development / validation / study sample analysis using HPLC, LC/MS/MS techniques as per principles of GLP, SOPs and approved protocols. 2. To plan and monitor the laboratory work involving the various processing techniques, analytical methods and standard operating procedures (SOPs) and complying with the principles of Good Laboratory Practices (GLP) as well as approved protocols to ensure the quality, integrity and reliability of the results. 3. To establish quality control program and safety of the staff and to establish corresponding cor...

To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control. Analysis of In-process, finished products, stability samples of various formulation products: oral solids, Topical, cosmetics. Responsible for investigation and initiation of change control, Laboratory incidents, CAPA, OOS, OOT. To Co-ordinate with Quality control Manager to prepared the Analytical Method Validation protocol and Report. To perform the analytical method validation as per requirmnet. To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control Also having sound knowledge about data integrity, ALCOA principals and respective...

About Apotex Inc. Job Summary Execution of analytical method optimization /development, validation/ verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes( SDC) and other procedural updations.Preparation of method validation/verification protocols and reports. Job Responsibilities Execution of Method optimization / development studies. Method validation/ verification of In-house methods, Compendia, SDC, MLCM and Cleaning Analytical methods by adhering to the regulatory procedures. Preparation of Method verification/ Method transfer Protocols and r...

Description: The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the labs continuous development through training and adherence to SOP Essential Functions: Candidate should have worked at least 3- 5 years in injectable ARD. Method development like Related compound, Assay, Dissolution and Residual solvents etc. ...

Job Description Accountable to ensure timely initiation, handling, tracking and closure of QAMS elements like change control, deviation. LIR, CAPA, OOS, OOT and their investigations. To prepare/ review Analytical validation protocols / Study protocols and their reports/method transfer report. Batch release/stability sample/Method validation analysis. QC lab training coordinator Work Experience 7to 14 years Education Post Graduation in Life Science or Biopharmaceutics Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-3 years of...

Required 1-2 years' experience in Analytical Research (Quality Control) Analytical Method Validation by using HPLC Hands on experience in handling HPLC. Will Be Preferred for shift working Required Candidate profile Knowledge about GLP Should have handled instrument like HPLC, GC, UV, Potentiometer, KF, Polarimeter, Dissolution etc. Should experiencing in Analytical Method Validation. Perks and benefits Mediclaim, 28 PL, 5 Days working, Birthday Leave

QC Daily Analysis Conducted tests Assay and Dissolution KF ,PH Preparation of solutions for HPLC Analysis Documentation preparation like SOP,MOA,MSDS,STP