100 Stability Studies Jobs

The role involves planning and resource allocation for routine operations within the analytical development function. You will be responsible for ensuring timely analysis of finished products and raw materials for various projects. Your duties will include reviewing analytical data, raw data, daily usage logbooks, and lab notebooks to support operations. You will also be involved in preparing and reviewing critical documents such as Analytical Method validation protocols, reports, method transfer protocols, and Standard Operating Procedures (SOPs). Additionally, you will conduct literature searches and provide guidance on new method development. Another key aspect of the role is to review data for stability studies and ensure timely analysis of samples. You will need to identify resource needs and initiate procurement to prevent delays in project deliverables. Supporting product technology transfers and ensuring compliance with safety measures will also be part of your responsibilities. In terms of quality management, you will be required to raise change controls, ensure data integrity, and adhere to Good Manufacturing Practices (GMP). You will also handle documentation related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and Occupational Health & Safety Assessment standards. As part of your job authority, you will review analytical data, plan and allocate resources, prepare and review SOPs, and technology transfer documents. You will also review calibration data, logbooks, and lab notebooks, as well as identify and report any near misses, hazards, or unsafe conditions. Other responsibilities include implementing QEHS policies and objectives, ensuring the use of personal protective equipment (PPE) during operations, and managing incidents and non-conformities effectively. You will also oversee work permit systems during maintenance activities and ensure proper waste disposal procedures are followed.,

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

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

As an Executive - Application Lab at Azelis India, your main objective is to develop innovation through formulation, application, sampling, and technical support in the Personal Care and Home Care products industry. You will be responsible for formulating a wide range of products, conducting stability studies, ensuring regulatory compliance, and working on sustainable product concepts aligned with market trends. Your role will also involve providing technical support to customers, conducting product demonstrations, and collaborating with suppliers on new ingredient innovations. In addition, you will manage the HPC application development lab, handle lab operations, support CAPEX planning, and maintain technical documentation. You will be required to provide internal technical training, evaluate market intelligence, develop marketing strategies, and monitor competition activities in the market. The ideal candidate for this role should have a B. Tech or M.Sc. in Chemistry/ M.Tech/Chemical Technology/cosmetologist with a minimum of 2-5 years of experience in technical/formulation development. Strong communication and collaboration skills, a sense of ownership, drive, and excellent organizational abilities are essential for this position. Fluency in English is a must, and proficiency in other languages is a plus. Adherence to work culture and ethics is also expected. Please note that the job requirements may evolve based on business needs, and you will be expected to adapt to changes and perform any tasks for which you are trained.,

You will be part of the Formulation Development team, contributing your expertise in Biologic Formulations and pharmaceutical sciences. Your responsibilities will include conducting literature reviews, formulating biological products, designing and executing experiments, analyzing data using various techniques, calibrating instruments, performing proof-of-concept studies, conducting stability studies, writing scientific reports, and collaborating with cross-functional teams. To excel in this role, you should hold a minimum of a Postgraduate degree (MTech, MPharm) in Pharmaceutical Sciences, Chemistry, or a related field. Proficiency in analytical techniques like HPLC, GC, pH, Osmolality, KF, and UV spectroscopy is essential. Effective communication, strong analytical and research skills, teamwork abilities, and knowledge of pharmaceutical excipients and raw materials will be key to your success in this position.,

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also include the preparation and maintenance of working standards with documents, as well as the operation and calibration of laboratory instruments like HPLC, GC, and Spectrophotometer. You will review and approve Raw material, finished product, and Packaging material specifications. Furthermore, you will be responsible for handling customer audits and regulatory authority audits and preparing compliance reports. Troubleshooting of HPLC, GC, and other instruments will be part of your responsibilities. You will manage the laboratory and work towards analytical laboratory improvement, cGMP and GLP compliance, and problem resolution. As the QA/QC Manager, you will be solely responsible for exports and quality-related issues for the unit. You will supervise QC chemists to ensure the smooth working of the department and to guarantee the best quality of products from the production. This is a Full Time position located in Byrathi, Bangalore.,

The Assistant General Manager - Nasal Spray Formulation Development will play a crucial role in leading the development of innovative nasal spray formulations within the Research & Development (R&D) department of a Pharmaceuticals company. Reporting to the Head of R&D, you will be responsible for driving projects from concept to commercial scale-up, ensuring regulatory compliance and meeting quality standards. Your primary focus will be on designing, developing, and optimizing nasal spray drug products for global markets. Key Responsibilities: - Develop and technology transfer Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Conduct literature search reports for drug substances and products, design product development strategies, and propose different formulation strategies based on the review outcomes. - Guide executives in lab development batches, provide expert input into formulation and process studies, and ensure compliance with specifications. - Evaluate packaging material vendors, monitor stability studies, and prepare/review Technology Transfer documents. - Coordinate with internal stakeholders, follow GLP & GMP, participate in stability and validation batch manufacturing, and prepare PDR for regulatory submission. Qualifications & Skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field. - Specialization in drug delivery systems or formulation science preferred. Experience: - 8-10 years of formulation development experience, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Proven experience in nasal spray product development from early-stage to commercial scale-up. Technical Expertise: - Strong understanding of nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience with device development and knowledge of regulatory requirements for nasal spray formulations. Project Management: - Strong project management skills, ability to manage multiple projects, work with cross-functional teams, and deliver results. Regulatory Knowledge: - Experience in preparing and reviewing regulatory submissions, familiarity with CMC requirements for nasal formulations. Leadership & Communication: - Ability to lead and develop a team, excellent communication and presentation skills for conveying complex scientific information. Problem-Solving & Innovation: - Strong analytical and problem-solving skills, ability to innovate and apply new technologies to improve drug delivery processes. Work Environment: - Primarily based at the R&D center with occasional travel to manufacturing sites, vendors, and regulatory meetings. Join us in this exciting role to contribute towards developing high-quality nasal spray formulations for global markets.,

Key Accountabilities Accountability Cluster Major Activities / Tasks Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform part method validation, forced degradation studies, excipient compatibility studies, reverse engineering, add-mixture studies, in-use studies, hold-time study and analysis of routine & stability studies Conduct cleaning validation studies Perform analysis of API, excipients and secondary material (packaging material, ink, adhesive etc.) Develop cost effective & time saving analytical method for new or existing product Evaluate the pharmacopeia and verify the documents Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Maintain the lab instruments / equipment and troubleshoot the issues Perform calibration (schedule / breakdown) and calculate instrument utilisation Up-keep the HPLC/GC/IC columns as per cGLP Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Record and document all analytical activities in timely manner in Lab note-book, instrument/equipment and column log book Provide base documents for MOA / COA preparation for better coordination in analytical studies Provide support to units or CFTs for transfer of analytical methods and techniques by visiting and demonstrating them with the relevant analysis to ensure successful and timely transfer of products Transfer methods and technologies to other units and departments Study the literature to resolve units and regulatory queries and conduct investigation studies in stipulated time period Analyse samples at pilot plant and unit for trace determination (Cleaning Validation) Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents Follow safety guidelines by ensuring use of PPE & MSDS of chemicals at time of analysis Upkeep the samples given for analysis and ensure timely destruction after analysis as per SOP Dispose solvents and waste generated during the analysis Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations Arrange analytical requirements like column, impurities, standards, placebo and samples for units and other department like Validation Lab or Outsourced Lab Review and recommend corrections in the MOA, COA & Specifications Major Challenges Delay in developing analytical method due to unavailability of HPLC/ GC columns, reference impurities and specific instruments. Overcome by prior planning and by using alternate resources Additional or rework due to frequent changes in project priorities. Overcome by proper planning Key Interactions Internal External Formulation R&D for improving the quality of product (Daily) Loan Licence Team for analytical requirements which has to be provided (Weekly) Units for execution of project in unit (Twice a week) CRO for outsource analysis, validation, verification, release etc. (Twice a week) Service Engineers for breakdown of equipment and instruments (Fortnightly) Dimensions Average number of projects : 8 (FY2016-17) Average number of analytical method developed : 10 (FY2015-16) Average number of part method validation : 7 (FY2015-16) Average number of method transfers / unit queries : 2 Average number of additional projects: 4 (e.g. CIP, CHC, POC, etc.) Average number of Tec Mar studies completed : 10 per year Average number of new monographs evaluated : 10 per year Key Decisions: Decisions Recommendations Finalisation of analytical method or any change in existing method to Group/Sub-Group Leader - Formulation ADL Comments: Skills & Knowledge Educational qualifications: M. Sc. (Analytical Chemistry) / M. Pharm. Relevant experience: 2-4 years of experience in pharmaceutical organisation with knowledge of handling instruments like HPLC, GC, Dissolution tester and DPI related instruments Knowledge of current guidelines like ICH, EMEA, WHO

YOUR ROLE The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Research Associate II, Stability Subject Matter Expert, applies sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics. The effective integration of chemistry and stability enables establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements. WHAT YOU WILL BE DOING Represent R&D Stability on project teams as a member of the project teams goals and success. Support development and implementation of stability strategies for new product development and sustaining project activities. Support development of GMP stability studies used to establish expiration dating and support labeling for product development. Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners. Provide valuable input to stability assessments and requirements for new products and/or current product changes. Ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life. Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale. Interact with manufacturing facilities to acquire information related to test methods and specifications. Author, review and verify technical data, protocols, and reports through use of Quality Documentation System. Act as study director for stability projects under guidance of senior Stability team members. Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry. Support development of new and/or optimization of existing processes and procedures to enhance stability related practices. Participate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members. Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles. Contribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, summarize data for reporting. WHAT YOU WILL BRING Under guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail. Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members. Experience working with sophisticated databases. Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools. Good technical writing skills. Proficient in analytical chemistry including theoretical knowledge and practical experience. Willingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met. Basic functional understanding of FDA, ISO, and Quality systems. Works well in a team environment across multiple time zones and demonstrates an inclusive attitude. Education and/or Experience: Bachelor s Degree with 8-12 years or Master s degree with 6-10 Years in a relevant scientific subject area.

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, Incidents, and Laboratory Assessment Reports. Preparing and reviewing SOPs, conducting SOP training, and providing training on Good Laboratory Practices to R&D personnel are also key tasks. Management of development stability samples, including protocol review, sample charging, stability calendar updation, and sample withdrawal, will fall under your purview. Other duties include handling the receipt, issuance, and management of RLDs and Exhibit batch samples, as well as issuing R&D documents like LNBs, Forms, and Logbooks for routine use. You will be responsible for maintaining the Document Archival room of R&D, issuing archived documents upon request, and managing the receipt, storage, issuance, and management of Working Standards, Reference Standards, Impurity standards, and Chromatographic columns. Additionally, you will review and approve Instrument/Equipment Qualification and calibration records. Your skills should include expertise in Quality Management systems, Good Laboratory Practices, Analytical Method Development & Validation review, Documentation Control, and Stability Studies. Intermediate proficiency is required in Product Development Report Review, Internal Quality Audits, and Review of Specification and MoAs. In addition, you should have a basic understanding of Training and advanced knowledge of USFDA, ICH, EMA Guidelines, and USP General Chapters. Qualifications: - M. Pharm. - M. Sc. (Chemistry/Biochemistry) Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team, with its various roles including Executive, Audit, Facilitator, Consultancy, and Service, partners with all aspects of the organization to drive success through effective people management.,

: Review of R&D developmental data of ARD and PD like Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, Study Reports, for accuracy, data integrity and compliance to systems, procedures and regulatory requirements. Review of Technology Transfer documents like Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications and MOAs. Conducting routine laboratory rounds for ensuring compliance to Good Laboratory Practices. Handling of Change Controls, Deviations, Incidents and Laboratory Assessment Reports. Preparation, review of SOPs and conducting the SOP Training. Conducting training of R&D personnel on Good Laboratory Practices. Management of development stability samples i.e. protocol review, sample charging, stability calendar updation and sample withdrawal. Receipt, issuance and management of RLDs and Exhibit batch samples. Issuance of R&D documents like LNBs, Forms, Logbooks for routine use. Maintaining Document Archival room of R&D. Issuance of archived documents against request.Receipt of document for archival through document inward register. Receiving, storage, issuance and management of Working Standards, Reference Standards, Impurity standards and Chromatographic columns. Review and approval of Instrument/Equipment Qualification and calibration records. Skills Required: Quality Management systems | Expert Good Laboratory Practices | Advanced Analytical Method Development & Validation review | Advanced Product Development Report Review | Intermediate Internal Quality Audits | Intermediate Documentation Control | Expert Review of Specification and MoAs | Expert Stability Studies | Expert Change Control, Deviation, Incident and Laboratory Assessment Reports | Expert Training | Beginner USFDA, ICH, EMA Guidelines, USP General Chapters | Advanced

GLA University is seeking applications for two full-time Assistant Professors of Pharmaceutical Chemistry for the Institute of Pharmaceutical Research at GLA University, Mathura campus. As an Assistant Professor, you will be responsible for academic instruction, research supervision, and actively participating in departmental development. We are looking for individuals with a strong academic background, research potential, and a passion for shaping the future of pharmaceutical education. The role of Assistant Professor in Pharmaceutical Chemistry is based at GLA University, Mathura (U.P.), and is a full-time, regular position. To be eligible for this role, you must hold a B. Pharm and M. Pharm in Pharmaceutical Chemistry / Medicinal Chemistry with a First Class. Additionally, you should have a minimum of 3 years of experience in teaching, industry, or research. Preferably, you should have 12 publications in peer-reviewed journals, which would be an added advantage. Your key responsibilities as an Assistant Professor will include teaching in the D. Pharm program, covering subjects such as medicinal chemistry, pharmaceutical analysis, and pharmaceutical chemistry courses. You will be conducting research in the field, mentoring students, and contributing to the academic community through publications and presentations. Furthermore, you will contribute to curriculum development and quality enhancement initiatives, as well as promote research in synthetic chemistry, drug design, and stability studies. If you are interested in this opportunity, please apply by sharing your updated CV at vikrant.sabharwal@gla.ac.in. Join us at GLA University to be a part of our academic community and contribute to the future of pharmaceutical education. #GLAUniversity #PharmacyJobs #FacultyRecruitment #AcademicCareers #PharmaceuticalEducation #TeachingOpportunities #ResearchJobs #HigherEducationIndia #PharmaFaculty #MathuraJobs #UGCJobs #PCIApproved #PharmaCareers #HiringNow #AcademiaJobs,

Hiring - ADL (AMD) - Nagpur Location Location - Nagpur MH Company - Pharma (MNC) Core OSD Formulation + Method Validation Experience Msc or Mpharm /bpharma Responsibility - Sr. Role Description 1. Analytical Method Development New analytical method development and troubleshooting of existing method of different types of Oral solids dosage form (Granules, Tablets, Pellets, Capsules etc.) for Regulated market projects or as per business need. 1. Ensure robust & cost effective method development of product by considering the available facility & resources 2. Conduct Literature survey, different pharmacopoeia & pharmacopeia forum search and review & application of same in AMD. 3. Conduct Pre-formulation studies (API characterization and Drug-Excipients compatibility studies). 4. Operation and calibration of different analytical instruments. 5. Take into account existing QC facility while developing any product for successful method transfer. 6. Analytical method validation and method transfer activity. 7. Maintain the Good Laboratory practices, Good Documentation practice and Good hygiene practices. 8. Prepare for all type of internal and external audit/inspection. 2. Stability Studies of R&D Products 1. Responsible for stability studies of new R & D products for Regulated market projects. 2. Responsible for interpretation of stability data of the products related to analytical methods. 3. Observations of stability trend and discussion of same with formulation team. 4. Management of stability batches analysis and take the decision for stability studies of different batches as per requirement. 3. Routine Support to F&D Team 1. Responsible for providing routine support for the new product development for regulated market projects. 2. Planning and execution of routine batches analysis in minimum possible time. 3. Analytical data review and to provide the online results and observations to F&D Team. 4. GLP, GDP and Documentation Support 1. Responsible for maintaining the overall GLP and GDP in the Laboratory and providing overall GLP support during day to day activities. 2. Maintenance of working standards, Impurities and reference standards 3. Responsible for preparation, review and approvals of all the documents generating in the ARDL laboratory. 5. Team Building 1. Ensure continuous training and up-gradation of knowledge of the R&D team so that they are at the cutting edge of technology. 2. Set challenging goals for team members to ensure they deliver as per their true potential & as per the need of organization. 3. Identify & nurture the top talent of team. 4. Arrange a monthly interaction with team members to understand & resolve their performance bottle necks & also give them feedback for course correction. Performing any other responsibility as per the requirement, in the larger interest of organization. Interested!!!Please share your cv at Neetij@selectsourceintl.com Thanks & Regards

Job Title: Scientist / Sr. Scientist API R&D Department: Research & Development Location: Kolkata Key Responsibilities: Analytical Method Development: Develop and validate robust analytical methods (HPLC, GC, LC-MS, UV, FTIR, etc.) for quantification, purity, stability, and impurity profiling of APIs (maintaining GLP) Method Validation and Verification: Conducting studies to confirm that the developed methods are suitable for their intended purpose, meeting parameters like specificity, accuracy, precision, linearity, and ruggedness, Prepare and review technical documentation, including method development reports, validation protocols/reports, and regulatory submission documents. Method Transfer: Facilitating the successful transfer of analytical methods to quality control or production laboratories, ensuring reproducibility across different instruments and environments. Stability Studies: Implementing and managing API stability programs to monitor how products perform under various environmental conditions over time, ensuring continued compliance with quality standards. Regulatory and Quality Support: Providing analytical data and reports in support of regulatory filings and ongoing quality assurance requirements. Troubleshooting and Problem Solving: Using analytical expertise and state-of-the-art equipment to resolve issues, such as product failures or abnormal impurity profiles, quickly and accurately. Instrument Calibration and Maintenance: Ensuring analytical instruments are properly maintained and calibrated for reliable and reproducible results. Reference Standard Management: Handling selection, qualification, and maintenance of reference standards for ongoing quality control. Routine analysis work Qualifications & Skills: M.Sc. / M.Pharm / B.Tech/M.Tech in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline. 3–8 years of relevant experience in a pharmaceutical R&D or CRO environment. Hands-on expertise in analytical instruments (HPLC, GC, UV-Vis/IR etc.). Sound understanding of ICH, USP/EP, and regulatory requirements. Proficient in data analysis, interpretation, and documentation. Strong problem-solving and communication skills; ability to work in cross-functional teams.

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will play a crucial role in leading method development, validation, stability studies, and technology transfer activities. Your meticulous nature and extensive experience will be essential in collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. You should possess strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement. Your responsibilities will include developing, optimizing, and validating analytical methods such as HPLC, GC, UV-Vis, and Dissolution according to ICH and regulatory guidelines. You will be responsible for preparing and maintaining validation protocols, analytical reports, and ensuring compliance with Good Documentation Practices (GDP). Additionally, you will oversee method transfer to QC, provide training, and address any troubleshooting issues that may arise. Conducting stability studies, preparing data reports, and collaborating with cross-functional teams to support product development will also be part of your role. Furthermore, you will be expected to investigate and resolve analytical issues, including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs) as necessary. Maintaining up-to-date documentation and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be integral to your responsibilities. You will also evaluate vendors and key starting materials (KSMs) and provide insights to management based on your findings. In terms of past experience, you should have a strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. Proven experience in method development, validation, and regulatory compliance is crucial for this role. Familiarity with global pharmaceutical regulations such as those from the FDA, EMA, WHO, and ICH guidelines is essential. You should also be skilled in handling regulatory submissions and documentation, possess excellent problem-solving abilities, and have experience mentoring R&D scientists. Familiarity with CAPA systems and good documentation practices will further strengthen your candidacy for this position.,

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for prior art, and establish proof of concept through experimentation. Collaboration with cross-functional teams including Manufacturing Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), and production teams across different geographies will be crucial for technology transfer and timely execution of submission batches. Your role will also involve identifying challenges, bottlenecks in development, and providing mitigation proposals at various stages of product development. Furthermore, you will be responsible for problem-solving, prioritizing activities, conducting development trials, and ensuring alignment with established milestones. Clear communication with internal stakeholders, proactive identification of challenges or risks, and adherence to business unit Key Performance Indicators (KPIs) will be essential aspects of your role. On a day-to-day basis, you will work closely with the formulation development teams to achieve key milestones, conduct experiments following QbD principles, and prepare presentations at different stages of product development. Your tasks will include literature reviews, sourcing API and Excipients, conducting preformulation studies, executing development trials, interpreting analytical data, and preparing necessary documentation for regulatory submissions. To be successful in this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 1 year of experience or an M.Pharm in Pharmaceutical Sciences with a minimum of 3 years of experience from reputable universities. Prior experience in working with generic pharmaceuticals in regulated markets such as the US, EU, or Canada will be advantageous. Your commitment to personal accountability, effective work habits, continuous learning, and collaboration with internal teams will be instrumental in contributing to the success of our organization's mission to make good health more affordable and accessible globally.,

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Who we are The opportunity Bench scientist with good analytical acumen in the area of formulation research and development, process development, Regulatory and Intellectual property for global markets. Planning and conducting of experimentation in line with project milestones. Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scaleup principles. Ability to comprehend facts and data from literature reviewed and present the information effectively for decision making. Understand IP scenario and work on various design around strategies, search prior art, and experimentally establish the proof of concept. Help identify the challenges associated, bottle necks in development and suggest mitigation proposals during development at various stages. Co-ordinate with CFTs viz. MS&T, QA, QC and production at different geographies for technology transfer and timely execution of submission batch(es). Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues. Priortize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization. Align day to day activities in line with established milestones, execution of batches at global TGO operation site. Clear comminications with internal stakeholders, for identfying challenges/risk areas which would hamper the timely delivery of products. Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives. Assist the domain leader in business process evalaution and identifying improvement areas. Demonstrate personal accountability and effective work habits, viz. working productively & act responsibly, and learn from mistakes. How you ll spend your day Work on bench with the formulation development teams for the timely achievement of key milestones. Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE. Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data To conduct literature review, prior art experiment design of the product identified for development. Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering. Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic formphase transformation studies, selection of excipients and process as per strategy. Conducting and performing the development trial at bench level, problem identification & resolution. Review and interpretation of analytical data for further action plan. Responsible for execution of Pilot BE batches and interpretation of bio results. Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results. Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE). Establish the stability data for development batches in collaboration with the analytical team. Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report. Co-ordination with various CFT S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product. Compilation and preparation of pharmaceutical development report with respect to current QbD format. Responsible for preparation of Product Developmental Report (PDR) for filling. Handling of deviations, change control and OOS related to Exhibit batches. Preparation, updation of SOPs. Maintaining of batch, calibration and other necessary records. Subjecting required batches to stability studies. Your experience and qualifications Ph. D. in Pharmaceutical Sciences with 1 Yrs +/ M. Pharm in Pharmaceutical Sciences with 3yrs+ from reputed universities Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. 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Role & responsibilities : 1) Having from OSD background. 2) Responsible for analysis of RM/IP/FG/Stability on HPLC. 3) Responsible for Calibration of HPLC 4)Having the Knowledge of the Pharmacopeia.IP/BP/Ph.Eur/USP Skill Required: 1) Handling of the HPLC, 2) Calibration Management. 3)Knowledge of the GLP Environment 4) Handling of the HPLC, 5) Calibration Management. 6)Working Standard, Ref. Standard, Imp Standard, Primary Standard Management Additional Remark: Required candidates background should be in Regulatory environments

Roles and Responsibilities To perform product lifecycle management tasks for externally supplied products and own production products like evaluation of change controls, deviations, temperature excursions, stability data, process validation documents from Product quality point of view. Handling of problem-solving cases for products (includes both analytical and formulation related changes which have impact on product quality). Overall product quality evaluation and provide input during suppliers meetings. Follow up with suppliers and/or other stakeholders for documents related to changes for externally supplied products. E.g., possible impurities in API and finished products risk assessment in line with updated guidelines. Requesting, follow-up and tracking of Product Quality Review (PQRs) related data. Preparation and evaluation of Product Quality Review (PQRs) for externally supplied products, related coordination and follow-up with suppliers and other stakeholders. Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to Product Quality Review (PQRs). Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at CROs/CQC. Writing and/or reviewing of process validation, technology transfer, study batch documentation for own products. Write/check/review pharmaceutical documents as per regulatory requirements. Candidate having knowledge of theoretical and/or possible Physico-chemical risks for products based on appropriate available data (E.g., evaluation of synthesis route of API, excipients, packaging materials details etc.) will be an added advantage. Write documents into Orion s IT systems. Preparation and maintenance of lists/documents/records and archiving at appropriate place. Co-ordination with other departments / partners. Achievements of responsibilities within the agreed timelines. To assist the overall working of Indian Pharmaceutical team. Other possible tasks appointed by Supervisors. Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years experience in Formulation R&D or API R&D activities in global Pharma industry Knowledge of organic chemistry/ Pharmaceutical medicinal chemistry/ synthetic chemistry will be an added advantage Ability to analyze the impact of change on Nitrosamine and/or other relevant physico-chemical risks assessment, if possible. Confirmed knowledge of EU requirements and ICH guidelines Candidate having interest and/or experience in pharmaceuticals documentation or any relevant pharmaceutical formulation / manufacturing related documentation will be preferred. Practical development skills from the laboratory to the production scale concerning different types of formulations (tablets, capsules, liquids, etc.) will be considered as an added advantage. Fluency in oral and written English Task oriented with learning attitude and Teamwork skills Confirmed skills of Microsoft Office are essential This job offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group Possibility to utilize your own strengths with the support of professionals Flexible, high spirit working environment where your skills are appreciated Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Bachelors/masters degree in pharmacy from a reputed College/University or Masters degree in chemistry from a reputed College/University At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https: / / www.orion.fi / en / careers / orion-as-an-employer / . How to apply and additional information Please fill Candidate Information Form on https: / / forms.gle / o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 31.07.2025

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

Location - Manufacturing Unit, Bommasandra Qualification - MSc - Chemistry Experience - 2- 5 yrs Role : Analyst LCMS/HRMS Key Job responsibilities: Analyst should able to carryout testing in method transfer and method verification activities. Subject matter expert on analysis of HPLC, LCMS, GCMS for both assay and impurities routine samples of in process, cleaning validation, SFG & Stability. Subject matter expert in analysis of nitrosamine impurities. Subject matter expert calibration of instrument and its management.

The Manager - Nasal Spray Formulation Development will lead the development of innovative nasal spray formulations, driving projects from concept to commercial scale-up. You will focus on the design, development, and optimization of nasal spray drug products, ensuring regulatory compliance and meeting quality standards. Leading a team of formulation scientists, you will collaborate with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Key responsibilities include having relevant experience in developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. You will be responsible for preparing and reviewing literature search reports for drug substances and products, proposing formulation strategies, guiding executives for development batches in the lab, providing expert input into formulation and process studies, and ensuring compliance with specifications. Additionally, you will evaluate vendors for packaging material, monitor stability studies, prepare Technology Transfer documents, coordinate with stakeholders, and adhere to GLP and GMP. Qualifications and Skills required for this role include an M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field with specialization in drug delivery systems or formulation science preferred. You should have 8-10 years of hands-on experience in formulation development, with at least 5 years focused on nasal spray or inhalation formulations. Technical expertise in nasal spray formulation techniques, drug-excipient interactions, device development, particle size distribution, viscosity, and droplet characteristics is essential. You should possess strong project management skills, experience in working with cross-functional teams, and knowledge of regulatory requirements for nasal spray formulations. Leadership qualities, excellent communication and presentation skills, problem-solving abilities, and a knack for innovation are crucial for this role. The work environment will primarily be based at the R&D center, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,

Role & responsibilities Preferred candidate profile Perks and benefits

QC Chemist