18 Stability Protocols Jobs

As a Quality Control Laboratory Compliance Specialist, your role involves ensuring compliance with SOPs and regulatory requirements. Your responsibilities will include: - Imparting training to QC Associates on SOPs and current regulatory requirements based on review observations. - Reviewing Analytical data such as Finished, Intermediate, Raw material, and Stability. - Ensuring accuracy of analytical data by reviewing electronic data and sequence audit trail against hard copy. - Reviewing Stability Protocols, Stability schedules, and Stability data sheets. - Reviewing master list of instruments, equipments, and Qualification documents. - Reviewing Preventive maintenance schedules, Calibratio...

As a Senior Executive at Dishman Carbogen Amcis Limited, your primary role will involve preparing DMF / ASMF / CEP dossiers in accordance with the ICH M4 CTD/eCTD guidelines. You will also be responsible for responding to queries from regulatory agencies and customers, preparing Applicants Part of ASMF as per customer requirements and restricted part of ASMF as per regulatory requirements. It will be your responsibility to initiate activities for timely notification or prior approval from regulatory agencies in case of any necessary changes to existing DMF / ASMF / CEPs on an ongoing basis. Key Responsibilities: - Prepare DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines - Respo...

Did you know that you already know us Almost every second tablet which is on the global market contains our products. This demands great entrepreneurial power so that we are always looking for people who take ownership and are not afraid of accountability. Now it is your chance to join! We are looking for laboratory based Formulation Scientist(s) with a solid pharmaceutical formulation background (API and excipients) to advise our customers on their formulation challenges. In this role you will formulate final dosage forms for customers with actual or model APIs to support them in their development programs. As part of a team of Formulation Scientists and with our Technical Managers in the m...

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company, engaged in developing high quality, affordable biosimilars to expand access to cutting-edge therapies globally. As a fully integrated pure play biosimilars organization, Biocon Biologics aspires to transform patient lives through innovative healthcare solutions. With a large portfolio of biosimilars under global clinical development and multiple commercialized products in developed markets, Biocon Biologics believes in the power of strong partnerships to co-create the future of healthcare and positively impact millions of lives. Key Responsibilities: - Adherence to cGMP, cGLP, and GDP standar...

Role Overview: As an Executive QC at PPL in Navi Mumbai, your main responsibility is to analyze and sample in-process, intermediate, and stability samples according to SOPs and cGMP requirements. You will be in charge of ensuring accurate documentation, preparing stability protocols and reports, and efficiently executing analytical tasks to support quality compliance. Additionally, you will handle delegated responsibilities of the reporting authority when they are not available. Key Responsibilities: - Analyze in-process samples. - Sample and analyze intermediate samples following SOPs and in-house procedures. - Sample and analyze stability samples. - Charge and withdraw stability samples. -...

As a remote analytical support personnel at PPL sites, your role involves reviewing analytical data and preparing various documents such as specifications, test methods, and protocols. You will be responsible for uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will prepare and review stability protocols and reports, and conduct stability data trending and analysis. Key Responsibilities: - Review analytical data generated in the analytical lab (QC/AS) including Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data in accordance with cGMP...

Job Title: Formulation Expert Herbal / Nutraceutical / Cosmetics. Location: Lakkenahalli, Ramanagara district, Karnataka 562127. Experience: 12-15 Yearsof experience. Qualification: M. Pharm (Pharmaceutics) or M.Sc. (Chemistry) with experience in formulation development. Job Summary: We are seeking a skilled and innovativeFormulation Expertwith over 12-15 years of experience in the development of herbal, nutraceutical, or cosmetic formulations. The ideal candidate will be responsible for end-to-end formulation development, from ideation to scale-up and commercial transfer. Key Responsibilities: Develop and optimize novel formulations and product concepts based on project requirements. Develo...

As a Quality Control Laboratory Compliance Specialist, your role will involve ensuring compliance with SOPs and regulatory requirements. You will be responsible for imparting training to QC Associates on SOPs and current regulatory requirements based on review observations. Your key responsibilities will include: - Reviewing analytical data for Finished, Intermediate, Raw materials, and Stability. - Ensuring the accuracy of analytical data by reviewing electronic data and sequence audit trail against hard copy. - Reviewing Stability Protocols, schedules, and data sheets. - Reviewing the master list of instruments, equipment, and Qualification documents. - Reviewing Preventive maintenance sch...

Role Overview: As a Senior Executive at Dishman Carbogen Amcis Limited in Bavla, Gujarat, you will be responsible for preparing DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines. You will also handle responses to queries from regulatory agencies and customers, prepare Applicants Part of ASMF based on customer requirements, and manage renewals and revisions for CEPs / annual reports for USDMFs / ASMF variations. Additionally, you will stay updated on global regulatory requirements, evaluate change control applications for regulatory implications, and provide regulatory input for analytical method validation reports and stability protocols. Key Responsibilities: - Prepare DMF / AS...

You will be joining Biocon Biologics, a subsidiary of Biocon Ltd, a global biopharmaceuticals company focused on developing high quality and affordable biosimilars to provide cutting-edge therapies to patients worldwide. As a fully integrated pure play biosimilars organization, Biocon Biologics aims to improve patient lives through innovative and inclusive healthcare solutions. With a large portfolio of biosimilars in global clinical development and commercialized products in developed markets like EU, U.S., and Japan, Biocon Biologics is committed to transforming healthcare and impacting millions of lives. Your role at Biocon Biologics will involve the following key responsibilities: - Adhe...

Job Position: Product development Associate Location: Mumbai HURC Business Context and Main Purpose of the Job This is an opportunity to work as an R&D Associate with Glow & Lovely (previously Fair & Lovely), the biggest skin care brand in India based in Mumbai. With this opportunity, as you work to make a real impact on business and the world, we'll work to help you become a better you! About Glow & Lovely Glow & Lovely is a leading skin care brand which serves millions of people around the world by offering safe, effective and affordable products which deliver glowing, even toned and radiant skin. Previously called Fair & Lovely, we changed our brand name to Glow & Lovely to embrace a more...

As a Quality Control Laboratory Specialist, your primary responsibility will be to ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements within the laboratory. You will be required to provide training to QC Associates on SOPs and current regulatory standards based on review observations. Additionally, your role will involve reviewing a variety of analytical data including Finished, Intermediate, Raw Material, and Stability samples. It will be your duty to meticulously review electronic data and compare it with hard copies to guarantee the accuracy of the analytical results. You will also be responsible for examining Stability Protocols, schedules, data sheet...

Azurity Pharmaceuticals is a specialty pharmaceutical company dedicated to providing innovative products for underserved patients. With a focus on unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline through integrated capabilities and a vast partner network. The company's patient-centric products cover various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan, benefiting millions of patients globally. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a talented and dedicated team committed to improving patients" l...

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports...

As a remote analytical support specialist at PPL sites, your main responsibility will be reviewing analytical data and preparing essential documents such as specifications, test methods, and protocols. You will be uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will also prepare and review stability protocols and reports, as well as perform stability data trending and analysis. Your day-to-day tasks will involve reviewing analytical data generated in the analytical lab, including cleaning verification data, IPC, raw materials, intermediates, finished products, stability, and method validation data in compliance with cGMP, GDP. You wil...

As a Formulation Scientist at BacAlt, you will be responsible for conducting research and development activities, performing laboratory experiments, and developing formulations in the field of transforming post-harvest waste into valuable biopolymers. Your role will be based in Bengaluru and will involve hands-on work in the laboratory, problem-solving, and meticulous documentation of research findings. Additionally, you will play a key role in the technology transfer processes to scale up formulations from the lab to production. To qualify for this position, you must hold an M.Sc. or Ph.D. in Cosmetic Science, Chemical Engineering, Polymer Chemistry, or a related field. You should have a mi...

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording t...

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...