746 Method Validation Jobs

Analytical Techniques: Versatile handling of HPLC, GC, PSD, UV, and FT-IR analysis, with hands-on experience in troubleshooting, calibration, and method validation. Statistical Analysis: Familiar with statistical concepts relevant to analytical method validation. Software: Skilled in MS Word and Excel for technical documentation, data analysis ( Excel-based statistical functions), and reporting. Regulatory Compliance: Experienced in managing USFDA and other international regulatory audits. Cross-Functional Collaboration: Strong ability to work effectively with QA, QC, and R&D teams to ensure method robustness and regulatory compliance. Must be having experience in API Designation - Executive...

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

1.Dy.Manager - ( QMS/VALIDATION) Exp-10-15+yrs in a pharmaceutical or analytical lab,especially validation,transfer and verification activity The analytical method validation specialist is responsible for developing,validating and transferring analytical methods to ensure they meet regulatory standards(ICH,USP,FDA,EMA) 2.Asst Manager-( QMS/VALIDATION) Exp-10-15+yrs in a pharmaceutical or analytical lab,especially validation,transfer and verification activity The analytical method validation specialist is responsible for developing,validating and transferring analytical methods to ensure they meet regulatory standards(ICH,USP,FDA,EMA) 3. Executive/Sr.Executive- 3 to 6+yrs Validation Execution...

.Quality Control officer/Executive Formulation, dissolution, stability studies Raw material, Stability, HPLC,GC experience required. (Preferably from Bangalore candidates who can join in 30 days)

We are hiring an experienced Analytical R&D professional with expertise in ICPMS ICPOES for method development and validation The candidate should have hands-on experience in elemental impurity analysis, instrument handling, and GMP GLP documentation

Job description: Related to the analysis of nitrosamine impurities such as NDMA (N-nitrosodimethylamine) and NDPA (N-nitrosodipropylamine) typically focus on analytical method development and validation, LCMS Analyst / Scientist Analytical Method Development & Validation by LCMS. Preparation of Protocols and Reports. Method Development and Validation by LCMS (nitrosamine) Develops and validates reproducible and appropriate analytical methods as needed respecting the GMP practices; Participates in analytical troubleshooting; Writes methods, validation protocols, validation reports and investigation reports; Performs analyses; Participates in drafting SOP/ working instructions. Required Candid...

As a Quality Control Testing Technician in a Cell Therapy Lab, your primary responsibility is to ensure the quality and safety of cell therapy products through rigorous testing and analysis. You will work in a highly regulated environment, adhering to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to support the development and production of cell-based therapies. This role requires a strong attention to detail, analytical skills, and the ability to work collaboratively with cross-functional teams. - Execute a variety of tests to assess the quality, purity, and potency of cell therapy products, including but not limited to viability assays, sterility testing, endotoxin...

Role Overview: As an Associate Scientist in Analytical Chemistry at Kenvue, you will be responsible for handling analytical testing activities for new product development projects, supporting changes to commercial products, and specific research-based assignments as part of Global operations. Your main role will involve delivering analytical testing and related documentation activities with a focus on compliance under the supervision of the team leader. Key Responsibilities: - Ensure qualification on assigned analytical technologies and instrumentation for testing capabilities. - Conduct testing on assigned analytical technologies such as HPLC/ UPLC, GC, IC, AAS, etc. - Execute the assigned ...

1. Operate and maintain HPLC, weighing balances, pH meters, densitometers, tube heating blocks, and other QC equipment. 2. Perform CRM-197 protein testing using HPLC and SDS-PAGE. 3. Conduct free carrier protein testing on HiBTT, HiBTi conjugate, and Pneumo conjugate using HPLC. 4. Perform molecular size testing by HPLC on HiBTT, HiBTi conjugate, and Pneumo conjugate. 5. Ensure online documentation as per Good Documentation Practices (GDP). 6. Execute method validation for various products. Demonstrate proficiency in analytical procedures and method validation. 7. Evaluate LOD/LOQ for rinse samples. 8. Verify packing materials and consumables for the Production Department. Test and release r...

We are looking for a skilled Senior Data Engineer with 4 to 7 years of experience to join our team, focusing on PowerBI development. The ideal candidate will have a strong background in data engineering and excellent technical skills. Roles and Responsibility Design, develop, and implement data models and architectures to support business intelligence solutions. Develop and maintain complex data visualizations using PowerBI. Collaborate with cross-functional teams to identify and prioritize project requirements. Ensure data quality, integrity, and security by implementing robust data governance policies. Optimize data performance and scalability through advanced analytics techniques. Provide...

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...

- Literature search & compilation, generating chemistry new approaches & simplification areas. - Experimentation, Documentation of hard copy & SAP entry. - Bounding of expt. Data sheets & analytical observations, Submission of Lab documents. Required Candidate profile - 5+ years of experience as Research Scientist. - Excellent analytical & Interpersonal skills.

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...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

About the Role 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 findi...

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...

Conduct laboratory tests and analyze results with high accuracy and attention to detail. Maintain and calibrate laboratory equipment to ensure proper functioning. Prepare and maintain accurate records of test results and patient information. Required Candidate profile Minimum 2 years of experience in a laboratory setting, preferably in a hospital or medical services setting. Strong knowledge of laboratory procedures and protocols.Excellent analytical skills

As an Analytical Scientist in the Analytical Development New Product Development (NPD) department of a Global Pharmaceutical MNC based in Bangalore, your role will involve the following responsibilities: - Conduct analytical testing for solid oral formulations including tablets, capsules, ODTs, softgels, and ER/DR formulations. - Develop and validate methods for assay, related substances (RS), dissolution, and stability following ICH guidelines. - Troubleshoot analytical issues, manage Out of Specification (OOS) and Out of Trend (OOT) results, and support Root Cause Analysis (RCA). - Operate and troubleshoot a variety of instruments such as HPLC, UPLC, GC-MS, LC-MS/MS, UV, IR, and XRD. - Sup...

NOTE: Only Male & Candidates from AP & Telangana Preferred. Kindly Understand the JD It's not for the Clinical Trails Department Masters degree level in Chemistry,M pharmacy & B pharmacy 2023,24,25 passed outs. 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 principles. Checking of the con...

Responsibilities: Experience in Method Validation. Experience in Stability Study. Experience of review Electronic data review and backup systems. Expert in Qualification of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Expert in Calibration of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Must have minimum 3+ years of experience as a Reviewer. Must have an experience of reviewing all types of QC software. Must be familiar with cGMP/GLP practices and ICH and FDA Guidelines. Required Skills Must be excellent in written and spoken English; net savvy and adept at computer skills. Logical thinking. Organizing. Good in communication. Required Qualification: - B.Sc/M.Sc - Chem...

Review and analyze health data to ensure accuracy and compliance with regulatory requirements.Collaborate with cross-functional teams to identify and resolve data discrepancies.Develop/implement effective data review processes to improve quality Required Candidate profile Strong understanding of employment firms and recruitment services.Excellent analytical and problem-solving skills, with attention to detail and the ability to work independently.

Review and analyze health data to ensure accuracy and compliance with regulations.Identify trends and patterns in health data to inform business decisions.Collaborate with cross-functional teams to develop and implement data-driven solutions. Required Candidate profile Strong understanding of health data principles and regulations.Experience with data analysis and interpretation techniques.Excellent communication and collaboration skills.

Regular Batch Analysis by using LCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS

Interested Candidate please share your resume to atull@harmanfinochem.com Job description Below are details for QC candidate to be recruited. Must have 3 to 6 yrs of experience in QC Should handle HPLC / GC instrument. M.Sc or B.Sc with experience also preferred. Should have worked in GLP /GMP environment Must have experience in API QC Shall have knowledge of 21 CFR / CSV / data integrity / validations Shall have knowledge of Method validation / Method transfer

Manager - Quality Control (Formulations) 10 to 15 years of experience in Pharmaceutical Industry especially in Formulations Unit. Should have experience in successfully handling Quality Audits. Thorough knowledge in all types of Analytical instruments, analytical methods, HPLC, Method validation and method development etc., Should possess profound knowledge and skills in OSD/Formulations products. Total Quality Management (TQM), preparation and successful implementation of SOP's. Should lead a team in QC department and responsible for TQM. Sound working knowledge in MS Office and computer skills. Responsible for day-to-day and periodical MIS reports. Coordination with Production, QA and othe...