9 Analytical Validation Jobs

You will be responsible for regulatory submission of new products, variations, response to queries, and life cycle management for the US and OAM regions. This will involve preparation of quality dossiers to ensure timely approvals. Key Responsibilities: - Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review documents such as Development report, scale up report, specification, stability protocol, analytical validation, etc., before initiation of Exhibit batches for adequacy. - Review & prepare responses to deficiencies to enable approval of products filed to regulatory agency. - Prepare and review variations, Annual notifications, and labelling...

Developing and validating analytical methods for the development of new and existing products Preparation and execution of method validation protocol and report. Designing and executing experiments to develop and validate analytical methods. Documenting and interpreting the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Ensuring compliance with safety regulations.

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Note: Walk In Interview at Vadodara. Date: - 28.09.2025 (Sunday) Job Location: Daman & Dahej Qualification:- M.Sc. (Chemistry)/ B. Pharma/ M. Pharma Experience:- 2-6 Years in (API or Solid Oral) Required Candidate profile * 2-6 years of experience into LCMS, HPLC, GC & Wet Chemical sections, Analytical Validation, Finished Goods, Raw Material, Stability & GLP

Role Overview: As a Quality Assurance Manager in the Biotech/ Pharmaceutical API industry with experience in Microbial Fermentation (Classical), your main responsibility will be to ensure compliance with regulatory guidelines and expectations. You will be in charge of preparing, reviewing, and approving all procedures, identifying gaps, and updating them as necessary. Additionally, you will handle day-to-day changes, deviations, incidents, market complaints, and investigations in a timely manner. Key Responsibilities: - Develop and train second-line personnel by imparting knowledge to operating level staff and supervisors on risk and science-based decision-making. - Coordinate with various f...

Walk In Interview at Vapi. Date : 14-09-2025 (Sunday) Designation: QC Officer-Sr. Officer Job Location: Daman Qualification: M.Sc (Chemistry). / B. Pharm/ M. Pharm Experience: 02 to 07 Years (OSD) Required Candidate profile Roles and Responsibilities: -Analytical Validation -Finished Goods -Stability -Raw material -GLP -(HPLC user must)

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 productivity improvem...

We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards. Roles & Responsibilities You will be responsible to review relevant Literature and stay updat...

Developing and validating analytical methods for the development of new and existing products Preparation and execution of method validation protocol and report. Designing and executing experiments to develop and validate analytical methods. Documenting and interpreting the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Ensuring compliance with safety regulations.