945 Method Validation Jobs - Page 3

1. Sampling and routine monitoring of water systems. 2. Environmental Monitoring of Clean rooms. 3. Microbial Limit Test of Finished products, raw materials and water samples as applicable. 4. Bacterial Endotoxin Test of finished products and water samples, BET method validation of products. 5. Maintaining stock of Microbiological media and consumables. 6. Sub-culturing of Microbial Cultures. 7. Growth promotion test of media. 8. Calibration/ Qualification of Microbiology Lab equipment as per schedules. 9. Maintaining Microbiology lab in hygienic condition. 10. Microbiological method Development and validation for Finished products. 11. Preparation SOPs/ STPs, Protocols and other documentati...

Preparation of protocol, raw data sheets, reports, incident reports, excel validation sheets and SOPS. Review of Method validation activities Knowledge and handling of HPLC and GC instrument activities Qualification Groups Post Graduation M.Sc Graduation B.Pharma Graduation D Pharmacy Post Graduation M.Pharma

1. Sampling and routine monitoring of water systems. 2. Environmental Monitoring of Clean rooms. 3. Microbial Limit Test of Finished products, raw materials and water samples as applicable. 4. Bacterial Endotoxin Test of finished products and water samples, BET method validation of products. 5. Maintaining stock of Microbiological media and consumables. 6. Sub-culturing of Microbial Cultures. 7. Growth promotion test of media. 8. Calibration/ Qualification of Microbiology Lab equipment as per schedules. 9. Maintaining Microbiology lab in hygienic condition. 10. Microbiological method Development and validation for Finished products. 11. Preparation SOPs/ STPs, Protocols and other documentati...

1. Method development and validation of Genotoxic impurities/ nitroso amine impurities/NDSRIs in pharmaceutical products/ substances by LC-MS/MS. 2. Method development and validation of Genotoxic impurities/ nitroso amine impurities in pharmaceutical products/ substances by GC-MS/MS. 3. Development of MS compatible methods for the HPLC RS methods for the identification of unknown peaks by LC-MS 4. Development of MS compatible methods for the identification of degradation impurities and unknown impurities

Department: Quality Control &Production Division: API Location: Raichure Open Positions & Experience: Sr. Executive 06 to 08 years Executive 06 to 08 years Sr. Chemist 03 to 05 years Chemist 03 to 05 years Department: Production Open Positions & Experience: Executive – 05 to 07 years Sr. Chemist – 04 to 06 years Chemist – 02 to 04 years

As a candidate for this position, your role will involve working in accordance with cGMP guidelines and ensuring compliance with current guidelines and SOPs. You will be responsible for aligning with the organization's goals and carrying out any additional responsibilities assigned by your reporting authority. Your duties will include performing instrument calibration and maintaining instruments/equipment as per SOPs, as well as following safety precautions outlined in laboratory procedures. Key Responsibilities: - Conduct method development studies for Drug Substance, Drug Product & In-process Materials related to Peptides. - Perform method validation studies for Drug Substance, Drug Produc...

Role Overview: As an LCMS Analyst in our laboratory team, you will be responsible for independently operating, maintaining, and troubleshooting LCMS instruments. Your expertise in LCMS will be crucial in performing advanced analytical testing and ensuring compliance with ISO 17025:2017 standards. Additionally, you will play a key role in method development, validation, and adhering to strict laboratory documentation practices. Key Responsibilities: - Independently operate, calibrate, and troubleshoot LCMS instruments. - Perform routine preventive maintenance and ensure smooth functioning as per SOPs. - Monitor system performance, control charts, and maintain updated instrument records (MOU, ...

Perform HPLC & GC testing for stability & finished products. Conduct HPLC analysis for cleaning samples. Support method validation, data compilation & reporting. Ensure Data Integrity, OOS, 21 CFR compliance, GMP documentation & lab incident handling

Responsible for all analytical activities in a small molecule Drug Discovery and Development environment. Driving analytical method development, characterization, and development support from early discovery through latest age and manufacturing.

Department - Quality Control (Shift Duty) Section - HPLC Experience - 2 to 6 years Qualification - M.Sc chemistry (Full time) Job description To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI. To perform Analysis (Chemical)of raw material/packaging material/in-process samples /intermediate /bulk & finished products/ process validation samples/ stability samples/ cleaning validation/method transfer sample, PD lab sample etc. To ensure that all tests carried out in the laboratory are documented contemporaneously in an appropriate authorized and controlled worksheet/ bound book. To make entries in the sample in...

As the Head of the DQA department in the Research & Development sector, your role involves leading the team to ensure the implementation of CGMP rules and regulations. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, and Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and Commu...

As a member of the team at Apotex Inc., you will be responsible for executing analytical method optimization, development, validation, and verification of various analytical test methods. Your role will involve working with Compendia, in-house developed methods, site transfer methods, regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes (SDC), and other procedural updates. You will also be involved in the preparation of method validation/verification protocols and reports. Your key responsibilities will include: - Executing method optimization and development studies - Conducting method validation and verification of in-house methods, Compendia, SDC, MLCM,...

Role Overview: As an Analyst - Quality Assurance (Analytical Quality Assurance) at Immuneel, you will be responsible for in-process and batch QC activities. You will collaborate with internal QA, manufacturing, quality control, facilities operations, environmental health safety, and regulatory departments to ensure Analytical QA requirements are met and compliant with cGMP standards. Key Responsibilities: - Conduct Analytical Quality Assurance and development quality assurance tasks. - Review specifications, STP & ATR of raw material, packaging/consumable material, in-process, DS, DP finished product, and stability samples. - Review Certificates of Analysis (CoA) for various materials and pr...

As a Quality Control Lab Technician at Biocon Biologics, you will play a crucial role in ensuring the implementation of a Data Integrity Culture within the Quality Control Lab. Your responsibilities will include: - Adhering to cGMP, cGLP, and GDP guidelines to maintain high-quality standards. - Performing stability-related activities and managing the receipt and storage of samples at the QC location. - Qualification and life cycle management of cell banks used in bioassays. - Planning, reviewing, and reporting results of sample testing for monoclonal antibodies and biosimilars. - Reviewing analytical reports, usage log books, and observation data sheets. - Preparing and reviewing method vali...

As an Officer- Microbiology at Actylis, your role involves performing sampling and analysis of finished products. You will be responsible for monitoring and recording day-to-day activities as per GDP guidelines, filing and documenting reports as per standards, and ensuring a clean, hygienic, and safe work environment. Your key responsibilities include: - Ensuring calibration and maintaining microbiology lab equipment - Performing microbial testing in accordance with USP, EP, IP, or customer guidelines - Conducting efficient and reliable microbial testing, including microbial parameters in water, product contact surface environmental monitoring, viable air monitoring, Microbial Limits Tests, ...

About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and...

Vipul Organics Limited (VOL) is a leading manufacturer of specialty chemicals and colorants, committed to innovation, quality, and environmental safety. With a strong legacy and global presence, we are now looking to strengthen our team with a dedicated Instrumentation Chemist at our Palghar unit. Key Responsibilities: Conduct precise chemical analysis using Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) . Ensure regular calibration, maintenance, and troubleshooting of GC and HPLC instruments. Record, analyze, and report test results in a timely and accurate manner. Maintain laboratory standards as per safety, regulatory, and quality protocols. Support the QC and R...

Corelate the material level knowledge to the electrochemistry of the device Define specification for materials for electrochemical systems considering the efficiency and reliability impacts Study new techniques and developments in electrochemical engineering and incorporate them Analysis and develop new materials, processes and testing methodologies for Electrolyser components. Execute material level tests that will expand the knowledge on components Lead problem solving activities on component and device level Collaboration with cross functional engineers Support relevant activities in lab and pilot scale operations. Support the characterization of materials using advanced techniques, anayl...

Role & responsibilities 1. To Lead RM/PM/FP Section. 2. Managing all QMS activities like OOS, OOT, deviation, change control and gap assessment. 3. Review of Laboratory SOPs/Specification/Qualification protocol. 4. To review process validation reports as per Protocol. 5. TO Maintain GLP in QC Lab. 6. To train & develop the team members as per their Job Description. Preferred candidate profile :- B.Sc/M.Sc - Chemistry with 8 to 10 Years of experience into Regulated Pharma companies. Minimum 2 years experience of team handling of Injectable/OSD QC Lab.

Roles and Responsibilities Conduct analytical testing of finished products, including dissolution, UV-Vis, KF, FTIR, and GLP compliance. Develop and validate analytical methods for solid oral OSD products using techniques such as GC, HPLC, and UV spectroscopy. Perform method transfer and validation activities to ensure accuracy and reliability of test results. Collaborate with cross-functional teams to resolve OOS/OOT issues and implement corrective actions. Maintain accurate records of laboratory data, reports, and documentation in accordance with cGMP guidelines.

Roles and Responsibilities Develop and manage analytical competencies to support various Research & Development programs, manufacturing divisions and technical service requests. Develop analytical methods for API, In-process samples, and Finished Products using HPLC techniques. Performed Wet lab test like Water content, LOD, Sulphated Ash, UV, Polarimeter and melting point like instruments. Performed analysis for Small molecule, Large molecule, Peptide and Oligonucleotide molecule. Collaborate with cross-functional teams to resolve method-related issues and improve process efficiency. Maintain accurate records of all experiments, results, and reports. Performed method development as well as ...

Role & responsibilities Job Responsibilities: 1. Handling of stability section independently. 2. Handling of additional stability studies, such as, Photo stability, In-use studies, freeze thaw studies. Split studies etc. 3. Preparation of stability protocols, reports and stability compilation. 4. Responsible for timely initiation, closure of QMS documents related Quality Control and implementation respective corrective and preventive action. (i.e. Change controls, Laboratory Incidents, OOS, OOT & CAPA) 5. Responsible to follow ALCOA + principle while doing the data recording. 6. Review of In-process, finished, stability, process validation, in-process, Raw material, Excipients, packing mater...

Oversee and manage quality control processes to ensure high-quality products. Develop and implement quality control procedures to improve efficiency and effectiveness. Collaborate with cross-functional teams to identify and resolve quality issues. Conduct regular audits to ensure compliance with industry standards and regulations. Analyze data and reports to identify trends and areas for improvement. Implement corrective actions to address quality concerns and enhance overall product quality. Job Requirements Minimum 8 years of experience in a related field, preferably in quality control or a similar role. Strong knowledge of quality control principles and practices. Excellent analytical and...

Experience in Quality Control Experience with HPLC and GC analysis Familiarity with laboratory equipment and instruments Ability to work independently and in a team Excellent organizational and time management skills AMV, AMD

Roles and Responsibility Develop and implement new analytical methods and techniques to enhance laboratory efficiency. Conduct experiments and analyze data to identify trends and patterns. Collaborate with cross-functional teams to achieve project goals. Maintain accurate records of experiments, results, and procedures. Troubleshoot issues and optimize analytical processes. Stay updated with industry developments and advancements in analytical chemistry. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official ch...