945 Method Validation Jobs - Page 13

Job Description: You should have exposure to Method Development, Method Validation, and Method Transfer as per the requirement of ICH. You will be responsible for preparing protocols and executing planning for activities as per the product requirement. Key Responsibilities: - Develop methods for analysis - Validate methods according to ICH guidelines - Transfer methods to different locations as necessary Qualifications Required: - Experience in Method Development, Validation, and Transfer - Knowledge of ICH guidelines,

Job Title: Executive – Analytical Development 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 work as per cGMP and ensure its...

Hands on experience in HPLC/GC including method development, routine analysis and method validations along with good documentation practices. Responsible to perform the Analytical method validation, method verification and method transfer activities.

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 .

Role & responsibilities Complete Analysis of various raw materials, In-process, Drug substance and finished Products in line with Pharmacopeia method and in-house Specification and test procedures. Change Control, Deviation, Root Cause investigation, CAPA, OOS, OOT, Incidence Calibration of Instruments HPLC , UV-Visible Spectrophotometer, pH Meter,KF Titrator, weight balance. Working standard preparation as per SOP. Ensure the timely analysis of samples GLP, GMP, GDocP (With respect to Regulatory Guidelines) Function in details of various Section of QC/QA(Eg.Raw Material, Finished Product,Stability Study etc. Data Integrity 21 CFR Part 11 Qualification, Calibration, Validation. Maintaining t...

The Manager of Analytical Development will be responsible for developing and implementing analytical methods, quality control, conducting laboratory skills, method development, and research and development (R&D) activities.. No of Vacancies 1. Education Bachelors or Masters degree in Pharmacy, Chemistry, or related field.

Job Description: Knowledge of calibration and operation of LCMS/GC systems with Empower software. Sound knowledge of analytical method development and validation. Handling final compilation of raw data and chromatographic data complying with GLP requirements. Preparing general lab SOPs and instrument SOPs.

4-10 years in HPLC method validation/development Qualification Required: Any graduate/post graduate Location: Manesar, Bahadurgarh Job Description: Calibration and operation of HPLC systems. Analytical method development and validation. Compiling raw data and preparing general lab SOPs. nan

We are looking for a skilled HR professional with strong expertise in Payroll Management, HR Analytics, and Dashboard Reporting, coupled with hands-on experience in Darwinbox HR Core Modules. The ideal candidate will drive operational excellence across payroll processes, ensure compliance, and enable data-driven decision-making through analytics and reporting.

JD: 1) Working as per company / management policy & reporting to Quality Control Head. 2) To conduct analysis and testing of Raw Material, Packing Material, In-Process sample, Finished goods, Stability samples etc. with the help of analytical instruments and techniques. 3) To calibrate / verifies analytical instruments i.e. ICP-OES, Ion Chromatography etc..and balances. 4) To trouble shoot analytical instruments. 5) Preparation and standardization of Volumetric Solution. 6) Preparation and maintenance of records for stock / reagents. 7) Analysis of samples for qualitative and quantitative test parameters as per specification. 8) To maintain record of analysis and supporting logbooks as per G...

Walk In drive for Formulation Analytical Research & Development - department (FAR&D) - Quality Inn Ramachandra, Ward No- 58, 31-41/10/1, Duvvada, Revenue, Visakhapatnam, Andhra Pradesh on 25.10.2025 (Saturday ) Requirement for Executive - FAR&D - Formulation Analytical Research & Development(FAR&D) Roles & Responsibilities : 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,...

Greetings!!! We are seeking for an API - Research & Development Synthesis role for a Pharma Manufacturing Company at Gurgaon, Haryana

Responsibilities: Analytical Operations: Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG). Operate and maintain analytical instruments :- HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards. Review and approve analytical reports and LIMS entries , Quality Systems & Compliance Implement and monitor Quality Management Systems (QMS). Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents. Prepare and review SOPs, STPs, and validation protocols. Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.) Documentation & Reporting Maintain ac...

Responsibilities: Lead and oversee the entire Quality Control department operations. Ensure compliance with cGMP, regulatory guidelines, and company quality standards. Review and approve analytical methods, specifications, and validation protocols. Supervise raw material, in-process, and finished product testing. Ensure timely release of batches and materials. Manage laboratory investigations, OOS, OOT, deviations, and CAPA. Coordinate with QA, Production, and Regulatory teams for smooth operations. Handle audits (internal, external, and regulatory) and ensure readiness at all times. Provide training, mentoring, and performance evaluation of QC staff. Drive continuous improvement, cost effic...

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

Walk-In Interview QC Department (1 to 9 Years Experience) Hyderabad 11th & 12th October On 11th October 2025 (Saturday) Time : 9:00 AM to 3:00 PM Location: 7-2-A2, Hetero Corporate , Industrial Estates, Sanathnagar,Hyderabad-500018 Location: Annora Pharma Private Limited, Sy No.261, Plot No13, Annaram (Village), Ginnaram (mandal), Hyderabad On 12th October 2025 (Sunday ) Time : 9:00 AM to 3:00 PM 3. Location: Hotel Krithunga Restaurant, 01st Floor, Above Reliance Smart, Opposite New Bus Stand, Jadcherla Hiring For: Quality Control (QC) API / Formulations / Injectables Experience Required : 1 to 9 Years Qualification : B.Sc / M.Sc / B.Pharm / M.Pharm Department : Quality Control HPLC, GC, Wet...

Complete all of the routine tasks that have been allocated. Retaining paperwork and records as required by the lab analysis. Finish any method validations that are required and transmit the jobs spreadsheets, raw data, and supporting documentation. Once the results are confirmed, send these documents to the appropriate charges for report production. Compliance with laboratory safety protocols in chemical and microbiological laboratories. Be willing to work extra hours or shifts. Key Results Areas ( KRA s) Key Deliverables : Complete documentation in compliance with the standards of the Quality system. Review the audit documentation and check that they are completed. Record actions in line wi...

Complete all of the routine tasks that have been allocated. Retaining paperwork and records as required by the lab analysis. Finish any method validations that are required and transmit the jobs spreadsheets, raw data, and supporting documentation. Once the results are confirmed, send these documents to the appropriate charges for report production. Compliance with laboratory safety protocols in chemical and microbiological laboratories. Be willing to work extra hours or shifts. Complete documentation in compliance with the standards of the Quality system. Review the audit documentation and check that they are completed. Record actions in line with laboratory specifications. A thorough compr...

Complete all of the routine tasks that have been allocated. Retaining paperwork and records as required by the lab analysis. Finish any method validations that are required and transmit the jobs spreadsheets, raw data, and supporting documentation. Once the results are confirmed, send these documents to the appropriate charges for report production. Compliance with laboratory safety protocols in chemical and microbiological laboratories. Be willing to work extra hours or shifts. Complete documentation in compliance with the standards of the Quality system. Review the audit documentation and check that they are completed. Record actions in line with laboratory specifications. A full understan...

Job Purpose and Impact The Assistant Manager - QC will provide expertise with all daily operations in quality control laboratories. In this role, you will support the buildup and maintenance of the rapid technology platform by providing reliable accurate analytical figures as well as perform validation and troubleshooting of new analytical methods to ensure they meet the requirements and deadlines. Key Accountabilities Provide analytical support to Rapid Technology Application platform by releasing precise and accurate results and ensure scope of testing parameter is sufficient to build MPA module. Provide ongoing technical support to stakeholders, investigate quality problems and deliver im...

Job Title: Executive – R&D Biotechnology 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 The candidate is expected to develop HP...

The ideal candidate brings 10- 15 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility ...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Assistant Manager based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 8-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)...

Executive for Micro R&D 1 Post based in Amritsar. The ideal candidate brings 6 - 8 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead...