746 Method Validation Jobs - Page 4

Analysis of Compendia, Raw material samples, Analytical method transfer samples, excipients, In-process and Finished product as per method of analysis by adhering to the regulatory procedures. Preparation and review of Memo, Method Verification/ Method validation protocols, Method Verification/Method validation reports, Method transfer summaries. To involve in investigations and excursions as per SOP, to provide technical support during investigations of OOS/OOT results and to identify assignable cause. Compendia changes review, method verification. To perform the cleaning validation as per the protocol. Perform all work in accordance with all established regulatory and compliance and safety...

Job Role: Analyst - Small Molecule Bioanalytical Laboratory Job Location: Bangalore, India About Company: Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facil...

We are currently seeking a data-driven and detail-oriented Program Intern to join Leap. This role will involve critical thinking, problem-solving, and analytical thinking to drive operational improvements and support strategic initiatives. The charter for this role will include: Work closely with the founder/senior leaders to turn ideas into validated experiments. Dive into industry trends, discover competitor insights while also working on user research. Build a hypothesis to solve the different problem statements, execute, validate and scale the results Align with stakeholders across the org to drive the actionables; be a driving force in cross-functional teams Present findings, recommenda...

As the Lead of the Residue Analysis & Instrumentation section in the laboratory, your role involves overseeing and managing the analysis of pesticides, antibiotics, veterinary drugs, mycotoxins, heavy metals, and other contaminants in food samples. You will be responsible for operating, supervising, and maintaining advanced analytical instruments such as LC-MS/MS, GC-MS/MS, ICP-MS / ICP-OES, HPLC, GC, AAS, UV-Vis, and FTIR. Your duties include ensuring compliance with NABL (ISO/IEC 17025:2017), FSSAI guidelines, Codex, and BIS standards. You will also be involved in method validation, verification, calibration, and measurement of uncertainty. Reviewing and authorizing test reports as an Auth...

Company Description At TAPI, we're not just a companywe're a community committed to advancing health from the core. As the world's leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we're shaping the future of health worldwide. Our strength lies in our peoplea team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that t...

Method Validation

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...

NOTE: Only Male & Candidates from AP & Telangana Preferred. Kindly Understand the JD It's not for the Clinical Trails Department For Bio-analytical: Bachelors / Masters degree level in Chemistry life science, pharmacy qualification. 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Bio-analytical: Role and responsibility: In process quality control of ongoing studies. Review of raw data, chromatograms and reports of the method validations and studies. Checking of all the instruments and equipments for the calibration status and appropriate labeling. Checking and monitoring of the day-to-day activities in the lab for compliance to SOPs and GLP principle...

Title Executive - R&D Quality Business Unit R&D Quality Job Grade G12A Location: Vadodara Key Responsibilities 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. Position Summary List of Responsibilities: To Review and approve o...

To Review and approve of Analytical method validation protocols , reports, Analytical method transfer protocol/reports, Plant Trouble Shooting Report, Various kind of Analytical technical report , Justification report, etc. To review and approve of QMS documents like change control, deviation, Action items, Investigations, CAPA for cGxP compliance and centralised QA oversight for Analytical Development Department and Microbiology. To review relevant raw data and report for traceability and adequacy to ensure that Method Validation / Method verification/ Method Transfer data verify scientific rigor, adequacy and completeness and to approve relevant reports. To assist in developing procedures ...

Role & responsibilities 1. Proper maintenance of LC-MS/MS/ HPLC/ UPLC and their records of calibration. 2. To develop and validate Bio-analytical methods. 3. To process and analyse biological samples for drug/metabolite concentrations 4. To compile raw data and record laboratory note books/logbooks 5. To maintain equipment logbooks 6. To assist Lab Manager in data analysis and compilation of reports 7. Proper operation and routine maintenance of laboratory equipment in Bio analytical department 8. Responsible for laboratory instruments like PH meter, analytical balance, micro pipettes, etc. 9. Recording and reviewing of all raw data, method SOPs method validation reports and bio analytical r...

Sterility, bioburden, endotoxin, AET/PET testing Method validation for medical & polymer products Lab setup, media prep, equipment handling Water (WFI/CS) & environmental monitoring Data review as per cGMP & compliance norms and Maintain lab records

Experience in Operation and calibration of LCMS /GC 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

An ADL (Analytical Development Laboratory) role in API job responsibilities includes developing and validating analytical methods for raw materials, intermediates, and finished APIs, performing routine

Position Summary: Seeking a Senior Software Development Engineer in Test (SDET) with approximately 8 years of hands-on experience in network product validation, automation, and quality assurance. The role emphasizes proficiency with both hardware and software testing, focused on next-generation networking and security features, and demands end-to-end ownership in automation frameworks, test strategy, and defect analysis. Key Responsibilities: Design and execute detailed test plans, strategies, and automation frameworks for enterprise networking and security products including firewalls and network interface cards (NICs). Drive feature test automation, primarily using Python, to increase cove...

Roles and Responsibilities These statements reflect the general description of the position and are not intended to be an all inclusive list of tasks to which employee may be assigned A. Prepare Sample analysis report, Incurred sample reanalysis report & Method validation report in compliance with standard operating procedure and respective regulatory requirements such as USFDA, EMA, TGA, MCC, CANADA, NMPA, etc.. B. Ensure additional summary/module 2 (as applicable) is prepared as per respective regulatory and sponsor requirements. C. Handle Sponsors or regulatory queries on lab reports. D. To ensure that lab reports are released within their timelines. E. Maintain documents and databases fo...

You will be joining ECO Paryavaran Laboratories and Consultants Pvt. Ltd. in Mohali as an experienced Quality Assurance professional. **Key Responsibilities:** - Maintain and update QMS documentation such as the Quality Manual, SOPs, and forms. - Conduct internal audits, manage non-conformities, and implement CAPA. - Prepare for and support NABL and external audits. - Maintain training and competency records of lab personnel. - Review test reports, calibration records, and quality control data. - Monitor environmental conditions, ensure method validation and equipment calibration compliance. - Maintain timely documentation, data traceability, and continual improvement initiatives. - Establis...

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 SunshineAs 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. - To Access Study Plan and Standard Operating Procedures and to comply with instructions given in Study Plan and Standard Operating Procedures. To record raw data promptly and ac...

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 In process Material. Responsible for method Validation studies of API In process Material. Responsible for stability studies of API In process Material. Responsible to align with organization goal. Responsible to investigation of plant OOS and OOT Other responsibilities assigned by reporting authority. Respon...

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...

The ideal candidate brings 1-6 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) Lead microbiology practices including EM, MLT, sterility assur...