253 Stability Studies Jobs - Page 5

The Job For QC Chemist will be responsible for ensuring that all raw materials, in-process materials, and finished products meet the highest standards of quality, safety, and compliance. This role requires strong technical knowledge, keen attention to detail, and adherence to GMP, GLP, and regulatory guidelines to maintain product integrity. Key Responsibilities Conduct quality control testing of raw materials, bulk, and finished goods as per SOPs. Perform physicochemical, instrumental, and microbiological analysis using methods such as HPLC, GC, UV, FTIR, pH meter, viscometer, and titrations. Ensure compliance with cGMP, GLP, and regulatory requirements (FDA, ISO, WHO-GMP). Prepare and revi...

About Us HCP Wellness Private Limited is a leading manufacturer of Skin Care, Cosmetics, and Oral Care products, committed to delivering innovative, high-quality solutions that combine science, safety, and customer trust. At HCP Wellness, we believe in teamwork, ownership, discipline, cleanliness, and safety values that guide every process from lab to shelf. Position Overview The QC Chemist Jobs will be responsible for ensuring that all raw materials, in-process materials, and finished products meet the highest standards of quality, safety, and compliance. This role requires strong technical knowledge, keen attention to detail, and adherence to GMP, GLP, and regulatory guidelines to maintain...

As a professional in the field of Quality Assurance, you will be responsible for various key tasks to ensure compliance with regulatory standards and the maintenance of high-quality systems. Your expertise in FDA GMP audits will be essential in guaranteeing adherence to regulatory requirements. Additionally, your experience in establishing and overseeing Quality Management Systems (QMS) will play a crucial role in maintaining compliance with GLP and cGMP standards. Your proficiency in creating, reviewing, and maintaining Standard Operating Procedures (SOPs) will be vital in ensuring consistency and efficiency in processes. You will also be tasked with managing and implementing change control...

JOB DESCRIPTION Job Title: Team Lead - QC Late Phase Stability. Job Location: Syngene International Limited, Bengaluru About Syngene: Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to saf...

JOB DESCRIPTION: Pupose:Deliver formulations in defined timeframe to meet product delivery goals for I&D Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site. Core Job Responsibilities . Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation. . Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing. . Use of QbD wherever required for Product and process optimization. . Ensure proper upkeep, maintenance and cal...

Job Description Telecom Structural Engineer Position Overview We are seeking a skilled Telecom Structural Engineer to join our engineering team. The role involves conducting structural analysis and design for telecom infrastructure including poles, towers, and RCC buildings. The ideal candidate will have strong technical expertise in load validation, building feasibility, and stability assessments, with hands-on experience in structural design tools such as AutoCAD and STAAD.Pro. Key Responsibilities Pole Load Validation: Perform detailed analysis and validation of pole structures subjected to antenna and equipment loads. Tower Load Validation: Conduct structural analysis of telecom towers (...

Pupose:Deliver formulations in defined timeframe to meet product delivery goals for I&D Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site. Core Job Responsibilities Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation. Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing. Use of QbD wherever required for Product and process optimization. Ensure proper upkeep, maintenance and calibration of the equipment...

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

Job Description Position: Junior research scientist (JRS)/Research scientist (RS) Job Location: - Plot No. 214, Borsad - Tarapur Road, Ta: Petlad, Dist: Anand, Gujarat, India. Department: R&D / Formulation Experience: 3-6 years in Nutraceuticals Formulations. Industry: Nutraceutical / Food / Pharma Manufacturing Reports To: Manager FRD. Job Type: Full-Time Company Profile: - Pharmanza Herbal Pvt. Ltd. is one of the few companies which is focusing on standardizing and proving the efficacy of Herbal products. Our strong supplier base, fully equipped R&D facility, FDA approved manufacturing facility, infrastructure for conducting human trials as well as our formulations unit provides a one stop...

Role: Manager / Senior Manager - Quality Assurance Job Location: Aurangabad (Chattrapati Sambhajinagar) At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make ...

You are invited to join Zydus LifeSciences Ltd. at their Injectable manufacturing plant in Ahmedabad. We are currently looking to fill the following positions: 1. Production: - Staff positions ranging from Executive to Assistant Manager require candidates with a B. Pharm / M. Pharm/ B.E background and 4 to 10 years of experience in Supervising and Controlling Production areas such as Isolator, Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, and Visual Inspection. Knowledge of QMS activities is a plus. - Plant Operator and Technical Assistant roles require candidates with a Diploma or ITI qualification and 3 to 6 years of relevant experience in operating production machines like Isolat...

JOB DESCRIPTION Job Role: Analytical Chemistry-Analyst Department : Analytical - BGRC Job Location : Bangalore About Syngene: Syngene (www. syngeneintl. com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practic...

JOB DESCRIPTION Job Role: Analytical Chemistry-Analyst Department : Analytical - BGRC Job Location : Bangalore About Syngene: Syngene (www. syngeneintl. com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practic...

Role & responsibilities Perform the calibration and preventive maintenance of the instruments as per the respective schedules. Analysis of raw material / finished products / stability samples / Dissolution profiling for R&D/ Plant support. Analytical Method Development /Verification Assay, Related substances, Dissolution etc . Perform the determination of KF factor, Daily verification of Balances, pH meter, Milli-Q water system, Hot Air Oven, Refrigerator temperature monitoring. Develop/ optimize the analytical methods by Chemical/ instrument analysis Verify/ validate the analytical methods by Chemical/ instrument analysis Preparation / Revision of Specification and Method of analysis for Ra...

As an experienced professional in the field of Analytical R&D, your primary responsibilities will include the calibration of analytical instruments, preparation, and maintenance of solutions and reagents. You will be entrusted with the critical task of analyzing development batches, stability samples, and comparative dissolution profiles. Leading the analytical method development and validation processes, along with preparation of method development reports, will be a key aspect of your role. Your expertise will be crucial in conducting drug solubility studies of active pharmaceutical ingredients, as well as executing API and excipient comparability studies. You will be responsible for the d...

As a Product Development Scientist at our company, you will be responsible for executing lab batches for Solid Orals and liquid orals, which includes formulation strategy, process selection, drug excipients compatibility, lead formulation selection, stability studies, and tech transfer in accordance with applicable regulations and ICH guidelines. You will also play a key role in advancing new formulations from idea generation through development and scale-up. Your primary task will involve evaluating and implementing ICH and Quality by Design (QbD) concepts during the Product development phase. This includes considering elements such as Quality Target Product Profile (QTPP), Critical Quality...

As an Analytical Chemist at our leading Contract Research Organization (CRO), you will have the opportunity to assist in conducting analytical testing of samples using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer under supervision. You will play a crucial role in preparing reagents, solutions, and standards following Standard Operating Procedures (SOPs) with precision and attention to detail. Your responsibility will include accurately recording and maintaining raw data, logs, and reports in compliance with GLP/GMP standards. By ensuring proper documentation, you will play a pivotal role in meeting regulatory and internal audit requirements. You will provide essential sup...

You will be responsible for ensuring the quality control and assurance processes within the food manufacturing industry. This includes conducting various tests on raw materials and finished products to verify physical, chemical, and microbiological properties, as well as ensuring that they meet established quality standards. Additionally, you will need to ensure compliance with regulatory requirements such as AAFCO, FSSAI, and other relevant standards, while implementing and monitoring Good Manufacturing Practices (GMP). Maintaining accurate documentation and records related to quality control will be a crucial part of your role. This includes keeping track of quality records, online quality...

Role & responsibilities: The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus The candidate should have experience in r...

Role & responsibilities Lead and manage the stability study program as per ICH guidelines. Plan, initiate, and monitor real-time, accelerated, and intermediate stability studies for all products. Ensure timely sampling, testing, and data review for all ongoing stability studies. Maintain and review stability protocols and reports, ensuring compliance with regulatory requirements. Handle stability chambers (qualification, calibration, and monitoring) and ensure 21 CFR Part 11 compliance. Provide managerial oversight for instrument calibration, qualification, and maintenance activities in QC lab. Ensure timely availability of reagents, reference standards, working standards, and lab consumable...

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

Role & responsibilities Experience in operation and trouble shooting of process in plant. Isolation and purification of different organic compound using column chromatographic and crystallization techniques. Optimize the process parameters, what-if studies, holding studies etc. for scale up. Investigation of OOS/OOT and stability related issues. Handled various reagents like NaH, NaBH4, Br2, BHA, n-BuLi,TMSCl, TFA,PPA, Raney Nickel, Pd/carbon & also hazardous chemicals like POCl3, SOCl2 etc. Reactions performed like Hydrogenation,Brominaion,Oxidation,Reduction and condensation. Handling of Moisture sensitive reactions. Study and understand the project requirements, identifying and collection...

As a Formulation and Process Development Scientist, you will be responsible for the formulation and process development of Solid Orals, Liquid Orals, and Semi Solids dosage forms. Your main tasks will include designing protocols and development plans for new products, conducting formulation trials, and evaluating stability data to finalize formulation compositions. You will also be involved in tentative costing Bill of Materials (BOM) and trial BOM preparation for trial execution. Additionally, you will prepare supporting documents for stability studies, resolve product stability issues, and develop manufacturing processes for R&D formulations to ensure successful technical transfer for larg...

You will be working as a Senior Executive in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac). Your primary responsibility will involve reviewing Raw Material, Packaging Material, In-process, Finished product, shelf life specification, and relevant Method of analysis. You will authorize the Testing worksheet and approve analytical data of various materials in LIMS. Additionally, you will ensure compliance with Good Laboratory Practices and review analytical method validations, transfers, and verifications. Your role will also include handling, storage, withdrawal, and reconciliation of stability samples, reviewing stability study reports, verifying outside laboratory ...

Role & responsibilities 1. Investigation & handling of stability related OOS/OOT. 2. Handling of Stability Chamber Management. 3. Review of analytical data related to stability. 4. Review and approval of stability summary reports for the Dossier submission. 5. Preparation and Review of stability protocol and report. 6. Approval of SOPs in DMS. 7. Evaluation of stability data, require for dossier submission. 8. Timely compilation of stability summary report Skills and Competencies: Strong knowledge of GMP, GLP, SOPs, and regulatory requirements. Excellent analytical and problem-solving skills. Strong attention to detail and organizational skills. Effective communication and interpersonal skil...