55 Stability Studies Jobs

Preparation of Stability Study protocol as per client request. stabilitychamber Analysis of Stability Sample and Finished sample and their Assay and Related Substance by HPLC and UV. working as a quality control Analyst with experience 7.10 years in HPLC Calibration, HPLC/UPLC Analysis, Trouble shooting, Stability Studies, Audit trail Review.

Job Responsibilities: 1. Document analysis procedures and the test results mainly bioburden testing, spectrophotometric testing and mechanical studies using UTM machines 2. Document product stability studies are completed satisfactorily and supported by correct product sample analysis 3. Establish a tracking mechanism for customer & field complaints and suggest corrective actions Profile: 1. You have experience of around 3 or more years in pharmaceutical industry 2. Educational Qualification - M.Sc./M.Pharm degree with strong interest in quality control documentation 3. You work accurately, technically minded and able to work independently after training in the matter entrusted to you. Experience in a formulations/ API industry is an asset

Planning & Co-ordinate Internal/ External/Customers Audits. Reviewing Customer audits and non-conformity reports and ensuring corrective actions are effectively implemented. Validation protocols and reports. Reviewing BMR, Analytical Records.

Summary The Production Master Data Manager (PMDM) supports GCS Planning and enables Primary and Secondary Packaging by setting up Recipes, BOMs and Production Versions in SAP. The PMDM ensures Line Function Quality by executing LU2 checks. Execute and monitor timely activities related to assigned area of responsibility under the guidance and accountability of more senior associates. About the Role 1. Creates entire Bill of Materials & Master Recipe for clinical studies and stability studies, including selection of primary packaging material and management of alternative Bill of Materials 2. Updates and performs checks of Master recipes or Bill of Materials in case of changes. 3. Describes the process and answer questions regarding Bill of material / recipe creation/change process during internal/external inspections. 4. Performs GMP conform documentation of above-mentioned activities. 5. Supports Tactical planner, SCM, CTSM, Purchasing, CLM in selectin. the most efficient packaging design 6. Coordinates with Tactical planner, Operational Planner and Supply Chain Manager ensuring on time quality check and availability of Bill of materials / master recipes for planning purposes and packaging activities. 7. Meets quantity, quality and timelines of all assigned tasks. 8. Collects data for KPIs in affected area. 9. Maintains packaging material library. 10. Proactively communicate key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members. Interpret results, evaluate data, draw conclusions and report back to team and management. 11. Monitor and report Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken. 12. Performs QC on Bill of material, Recipe and assigned label. 13. Ensures that best practice, GMP and SAP requirements are respected for every production version. 14. Liaises with Master Data Management for timely material status change to L2. 15. Collects data for KPIs (e. g. RFT) 16. Coordinates with Production Master Data Team and SCM/Tactical Planner regarding required changes to BOM or Recipe (incl. downgrading their status) Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

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

integration with labware LIMS, Previous responsibility: *Finished product section head: responsibility were, SFG, FP, Inprocess, cleaning samples planing for analysis, incident, deviations, Investigation, CAPA, Effectiveness monitoring and change management related to finished section. *timely releasing of products. *Raw material and packaging material section head, incident, deviations, Investigation, CAPA, Effectiveness monitoring and change management related RM/PM. *timely releasing of materials. *products validation and method transfer. *Stability section head, stability study protocol prepration, review, stability chamber management, monitoring of samples charging, timely analysis, stability summary report compilation, *Ensure timely closing of OOT, OOS, deviations. *regulatory affairs responce and products submitted queries responce. *Laboratory software audit trail review and compliance, safety management. If interested mail cv at : NeetiJ@selectsourceintl.com

Role & responsibilities 1. To undertake literature search & preparation of reports for a new development project. 2. To execute analytical method development trials as part of prototype development till technology transfer of new drug products at the manufacturing QC sites. 3. To guide & supervise development trainees or associates during analytical method / development of new formulations. 4. To prepare Master documents of Analytical Method Development / Analytical reports for submission & validation batches. 5. Material Master creation of Material code/ Vendor code in ERP of MIC creation of Analytical Raw material / Packing material / Finished products in ERP 6. To raise requisitions of analytical materials viz. Working, Impurity Standards, Columns, reagents & Solvents etc. for analytical method development requirements. 7. Involving in all Analytical Development QA activities & ensure compliance. Interested candidates can share their resume at shikha.mishra@walterbushnell.com

Job Description JOB Details Position : Manager - Formulation and Development, Dermatological OTC Products Job Location : Ahmedabad- Bhopal About the Role: We are seeking an experienced formulation professional to lead the development of dermatological OTC products across the US, Europe, Australia, New Zealand, CIS, and Rest of World markets. This role encompasses end-to-end ownership of formulation activities, including both new product development and enhancements to existing products. The ideal candidate will demonstrate a strong track record in delivering robust, stable, and cost-effective formulations that align with defined target product profiles, timelines, and budgets. Additionally, the position requires a proven ability to drive innovation in formulation approaches, contribute to intellectual property generation, and ensure seamless technology transfer from development to commercial manufacturing. Key Responsibilities: Product Development Lead end-to-end formulation development for derma OTC products, from concept creation to commercial scale-up, developing robust formulations that meet target product profiles, regulatory requirements, and manufacturing constraints. Design and execute stability studies to ensure product efficacy throughout shelf life while optimizing existing formulations to improve efficacy, stability, sensory attributes, and cost-effectiveness. Partner with packaging development to ensure compatibility between formulations and packaging components, evaluating and selecting appropriate packaging materials that consider product stability, usability, and regulatory compliance. Benchmark our existing formulations against successful reference products in international markets, ensuring our developments align with global quality standards while maintaining our competitive edge. Technical Leadership Provide scientific expertise on dermatological active ingredients, excipients, and delivery systems, while applying innovative approaches to solve complex formulation challenges. Stay current with emerging technologies and scientific advances in topical/dermatological OTC products, serving as a technical resource for cross-functional teams on formulation matters. Project Management Manage multiple development projects concurrently, prioritizing resources effectively while creating and adhering to project timelines, budgets, and resource plans. Identify and mitigate technical risks throughout the development process, documenting and communicating development progress, challenges, and solutions to stakeholders. Team Leadership Supervise and mentor formulation executives while fostering a collaborative environment that promotes innovation, continuous improvement, and capability building within the formulation team. Collaborate effectively with cross-functional teams including Regulatory Affairs, Manufacturing, Quality, and Management Team to ensure seamless product development and commercialization. Manufacturing Support Lead technology transfer of new formulations to manufacturing sites and support scale-up activities and process development for commercial manufacturing. Troubleshoot manufacturing issues related to formulation aspects and develop and maintain standard operating procedures for formulation processes. Qualifications Education & Experience Master's or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, with 10 years of handson experience in formulation development of topical/dermatological products. Proven expertise in developing OTC products in alignment with regulatory standards, with a strong track record of taking formulations from concept to successful commercial scale-up for the US, Europe, Australia, New Zealand, CIS markets Technical Expertise In-depth knowledge of dermatological product formulations such as creams, lotions, gels, and ointments, with a strong understanding of excipient functionality, stability, and compatibility. Familiarity with OTC monographs and regulatory requirements for dermatological products, along with experience using formulation design software and statistical design of experiments (DoE). Leadership & Strategic Skills Proven project management abilities with experience handling multiple projects simultaneously, along with strong verbal and written communication across all organizational levels. Demonstrated problem-solving skills and scientific curiosity, complemented by team leadership experience, including coaching and mentoring capabilities. Please Expedite and Send the Updated Resume Along with requested details and confirmation of interest. Regards, Pooja Raval - Sr. for detail discussion, if your Profile is relevant.

Job Description JOB Details Position : Manager - Formulation and Development, Nasal-Based OTC Products Job Location : Ahmedabad- Bhopal About the Role: We are seeking an experienced formulation professional to lead the development of nasal-based OTC products including nasal sprays, throat sprays, and nasal inhalers across the US, Europe, Australia, New Zealand, CIS, and Rest of World markets. This role encompasses end-to-end ownership of formulation activities, including both new product development and enhancements to existing products. The ideal candidate will demonstrate a strong track record in delivering robust, stable, and cost-effective formulations that align with defined target product profiles, timelines, and budgets. Additionally, the position requires a proven ability to drive innovation in formulation approaches, contribute to intellectual property generation, and ensure seamless technology transfer from development to commercial manufacturing. Key Responsibilities: Product Development Lead end-to-end formulation development for nasal-based OTC products, from concept creation to commercial scale-up, developing robust formulations that meet target product profiles, regulatory requirements, and manufacturing constraints. Design and execute stability studies to ensure product efficacy throughout shelf life while optimizing existing formulations to improve efficacy, stability, sensory attributes, and cost-effectiveness. Partner with packaging development to ensure compatibility between formulations and specialized delivery systems (sprays, inhalers, etc.), evaluating and selecting appropriate packaging materials that consider product stability, usability, and regulatory compliance. Benchmark our existing formulations against successful reference products in international markets, ensuring our developments align with global quality standards while maintaining our competitive edge. Technical Leadership Provide scientific expertise on nasal delivery systems, active ingredients, excipients, and preservative systems, while applying innovative approaches to solve complex formulation challenges specific to nasal/throat administration. Stay current with emerging technologies and scientific advances in nasal drug delivery systems and formulations, serving as a technical resource for cross-functional teams on formulation matters Project Management Manage multiple development projects concurrently, prioritizing resources effectively while creating and adhering to project timelines, budgets, and resource plans. Identify and mitigate technical risks throughout the development process, documenting and communicating development progress, challenges, and solutions to stakeholders. Team Leadership Supervise and mentor formulation executives while fostering a collaborative environment that promotes innovation, continuous improvement, and capability building within the formulation team. Collaborate effectively with cross-functional teams including Regulatory Affairs, Manufacturing, Quality, and Management Team to ensure seamless product development and commercialization Manufacturing Support Lead technology transfer of new formulations to manufacturing sites and support scale-up activities and process development for commercial manufacturing of nasal sprays, throat sprays, and inhalers. Troubleshoot manufacturing issues related to formulation aspects and develop and maintain standard operating procedures for formulation processes. Qualifications Education & Experience Master's or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, with 10 years of handson experience in formulation development of nasal/respiratory products. Proven expertise in developing OTC nasal products in alignment with regulatory standards, with a strong track record of taking formulations from concept to successful commercial scale-up for the US, Europe, Australia, New Zealand, CIS markets. Technical Expertise In-depth knowledge of nasal drug delivery systems, formulation principles for nasal sprays, throat sprays, and nasal inhalers with special focus on isotonicity, pH, viscosity, and preservative systems. Strong understanding of excipient functionality, stability, and compatibility specific to nasal/respiratory applications. Familiarity with OTC monographs and regulatory requirements for nasal products, along with experience using formulation design software and statistical design of experiments (DoE). Experience with specialized testing methods relevant to nasal products (spray pattern analysis, droplet size distribution, delivered dose uniformity, etc.). Leadership & Strategic Skills Proven project management abilities with experience handling multiple projects simultaneously, along with strong verbal and written communication across all organizational levels. Demonstrated problem-solving skills and scientific curiosity, complemented by team leadership experience, including coaching and mentoring capabilities. Please Expedite and Send the Updated Resume Along with requested details and confirmation of interest. Regards, Pooja Raval - Sr. for detail discussion, if your Profile is relevant.

Role & responsibilities a. Perform routine testing of raw materials, in-process, and finished products as per approved methods. b. Operate analytical instruments like HPLC, GC, UV, FTIR, and dissolution apparatus. c. Maintain and document all test results accurately in compliance with cGMP and GLP guidelines. d. Support stability studies, method validation, and method transfer under supervision. e. Assist in investigation of OOS/OOT results and follow SOPs strictly. f. Ensure proper calibration and maintenance of laboratory instruments. g. Maintain lab safety, cleanliness, and participate in regular training programs. h. Coordinate with other team members to ensure timely completion of lab activities. Preferred candidate profile Candidates having experiences in Pharma formulation(OSD) in EU/USFDA units will be preferred

Must have experience into Method Development into Stability Analysis Mpharma is must Preferred candidate profile Must have worked in Pharma Company

Job Role : Analytical Chemistry-Analyst (NPD) 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 practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times. Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, Particulate matter analysis using Malvern, PAMAS, HIAC and other relevant instrumentation techniques. etc. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers, Particulate matter analysis techniques. Shall have experience on Good documentation/laboratory practices such as ALCOA+. Experience in calibration and qualification of various analytical instruments HPLC, UPLC, GC, and other QC laboratory instruments Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control). Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards / Chemicals / Reagents / Consumables / Spares etc., required for the projects Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Must possess good communication and e-mail etiquettes. Behavioural Skills Good Interpersonal skills Self-time management Good team player Good communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 1-6 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-visible spectrophotometer, Potentiometer, Particulate matter analysis techniques and QC other analytical instruments Theoretical knowledge in Chromatography and spectroscopy technique Good documentation/laboratory practices such as ALCOA+. Able to follow work instructions and perform the tasks under the supervision of the Team leader Preparation and Maintenance of all the documents Good knowledge of MS-office (word, excel, ppt) Education M. Pharm/ M. Tech/ M.Sc. / B.Tech., B.Sc. (Analytical chemistry/Chemistry) Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

01 To 02 Year in years of experience in Quality Control in an Ayurvedic / herbal / pharmaceutical company. Education Qualification: M.Sc | B.Pharm |M.Pharm (Ayurveda or Pharmaceutics preferred). Department: Quality Control Ayurvedic Location: Santej Ahmedabad. * Transportation Facility Available (As Per Circumference Of Sunrise Remedies) Mediclaim and Food Facility provide By Company. Key Responsibilities: Conduct routine quality checks and testing of raw materials, packaging materials, in-process samples, and finished Ayurvedic products. Ensure compliance with AYUSH regulations, GMP, and ISO standards where applicable. Maintain and calibrate lab instruments such as HPTLC, UV-Vis Spectrophotometer, pH meters, etc. Prepare and maintain Standard Operating Procedures (SOPs), test reports, COAs, and specifications for materials and products. Conduct microbiological testing and stability studies as required. Collaborate with the production, and QA departments for troubleshooting and quality-related investigations. Handle non-conformance reports (NCRs) and support in CAPA implementation. Review batch manufacturing records (BMRs) and ensure quality documentation is in place. Support in regulatory audits (AYUSH, FSSAI, WHO-GMP, etc.) and third-party inspections. Please drop your CV or Resume to info@sunriseremedies.in Our HR Department will get in touch with you.

Ensuring timely development of innovative and client-specific formulations for skin care range Stay up to date with trending ingredients, active technologies, and market trends in skincare, and personal care. Supervise formulation trials, stability studies, and efficacy testing to ensure product performance and regulatory compliance. Coordinate with clients and the sales team to understand project briefs and convert them into viable, scalable formulations. Ensure accurate documentation including formulation records, product dossiers, trial reports, and compliance paperwork. Work closely with QA/QC, Production, and Packaging teams for smooth handover of formulations for scale-up. Handle cost optimization without compromising product efficacy and quality. Lead innovation projects and explore opportunities in cosmetics, clean beauty, and sustainable formulations. Competencies Domain Knowledge (R & D Processes & Experiments) Knowledge about analytical instruments & technologies Education Master of Engineering/Tech in Other or Other Bachelor of Engineering/Tech in Other or Other

Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i.e.: Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Work Experience 1-5 years Education Post Graduation in Life Science or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Work Experience 1-5 years Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i.e.: Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Education Masters in Life Science Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i. e. : Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Work Experience 5-10 YEARS Education Post Graduation in Life Science or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i. e. : Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Work Experience 7-12 Years Education Post Graduation in Life Science or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Responsibilities: * Develop analytical methods for injectables using HPLC & GC. * Conduct method transfers, stability studies, & dissolution tests. * Validate methods through analysis & injection experiments. Health insurance Provident fund

* For Quality Control (IPPT/FP, RM/PM):- To perform all test for in process product & finish product as per the specification and schedule. To investigate failure of FP / Out of specifications (OOS) and take the corrective and preventive actions (CAPA). To perform and ensure the calibration of instruments as per the schedule. To perform and ensure preparation of reagent / volumetric solution as per schedule. To perform and ensure observation of FP retained samples. To ensure that all documents related to the testing data and related papers are maintained properly. To implement Corrective and Preventive Action (CAPA). To carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To carry out the testing of Raw Material and Packing Material according to approved procedure. To release Raw Material and Packing Material. To carry out the calibration of instruments as per the schedule. To prepare the working standards as per the guidelines and various pharmacopoeias. To ensure the status tag on the released material and transfer such material in the released area. To follow the Good Laboratory practices and Good Manufacturing practices (GMP). To prepare requirement list of chemical & reagent for procurement. To perform the analysis of stability sample as per current specification. To compile the data required for internal quality audit in the plant, as and when required. * For Quality Control (Stability):- To implement the change in procedure as per change control note. To check and verify the sampling of respective samples as per defined intervals for testing. To check and verify that the samples are kept at appropriate temperature and humidity as per defined procedure, which is as per the Standard Operating Procedure. To verify results of analysis conducted in respective period, and to carry out trend analysis. To coordinate with Purchase department for routine requirement and follow up for the procurement. To sign the documents related to stability studies data. To select product batches for the stability studies. In the absence of Officer, Executive will ensure his roles and responsibilities. In the absence of Executive, Sub-department Manager will ensure these roles and responsibilities. To file deviation in case of non-compliance * For Quality Control (Micro):- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines. To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam. To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index and other testing as per the requirements. To analyze the samples of water system after maintenance work . To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same. To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same. Candidate Profile:- Ready to work in Rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. The above mentioned requirement is for Male Candidate Only. Hence can be ready to work in rotational Shift. Candidate having Parenteral /Injectable exposure would be preferable . Candidates having Pharma exposure will only be considered for interview process. Fresher can also email their CV on Anee.Silas@otsukapharma.in

Job Purpose (Why Job Exists?) Jr. Cosmetic Formulator Key Result Area Ensuring timely development of innovative and client-specific formulations for skin care range Stay up to date with trending ingredients, active technologies, and market trends in skincare, and personal care. Supervise formulation trials, stability studies, and efficacy testing to ensure product performance and regulatory compliance. Coordinate with clients and the sales team to understand project briefs and convert them into viable, scalable formulations. Ensure accurate documentation including formulation records, product dossiers, trial reports, and compliance paperwork. Work closely with QA/QC, Production, and Packaging teams for smooth handover of formulations for scale-up. Handle cost optimization without compromising product efficacy and quality. Lead innovation projects and explore opportunities in cosmetics, clean beauty, and sustainable formulations. Competencies Domain Knowledge (R & D Processes & Experiments) Knowledge about analytical instruments & technologies Authorities Reporting Sr. Cosmetic Scientist Experience & Relevant Industries Other Education Master of Engineering/Tech in Other or Other Bachelor of Engineering/Tech in Other or Other

Role & responsibilities Position Summary: As an Analytical Scientist at Off Targets Research, you will play a crucial role in the development and validation of analytical methods for the characterization of pharmaceutical products. You will work closely with cross-functional teams to support the research, development, and manufacturing processes by providing accurate and reliable analytical data. Key Responsibilities: Develop, validate, and optimize analytical methods for the analysis of pharmaceutical compounds using techniques such as HPLC, GC, and spectroscopy. Perform routine and non-routine analysis of raw materials, intermediates, and final products to ensure compliance with regulatory standards. Collaborate with R&D, Quality Control, and Manufacturing teams to troubleshoot and resolve analytical challenges. Prepare and review technical reports, method validation protocols, and standard operating procedures (SOPs). Maintain and calibrate analytical instruments, ensuring they are in proper working order. Interpret and present analytical data to support decision-making processes. Stay current with industry trends and advancements in analytical techniques. Preferred candidate profile Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is preferred. Proven experience in analytical method development and validation, preferably in the pharmaceutical or biotechnology industry. Proficiency in using analytical instruments such as HPLC, GC, LC-MS, and spectroscopy. Strong understanding of regulatory requirements (e.g., FDA, ICH guidelines) related to analytical methods. Excellent problem-solving skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Strong written and verbal communication skills. Perks and benefits Opportunity to work on innovative research projects that contribute to groundbreaking therapies. Collaborative and inclusive work environment that values professional growth and development. Competitive salary and benefits package. A chance to make a real impact in the field of pharmaceutical research. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

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

Roles and Responsibilities Coordinate and follow-up with internal and external partner to review and evaluate Nitrosamine impurity and ensuring compliance to relevant guidelines. Managing and developing the process for Excipient GMP risk evaluation including maintenance of the structure with functionalities. Review elemental impurities statement, its impact on final product and ensuring compliance. 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 contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products. Write documents into Orion s IT systems for example analytical methods Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to PQRs. Requesting, follow-up and tracking of PQR related data. Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials Co-operation with other departments/ partners Local in-licensing support 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 work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry Knowledge of EU and US requirements and ICH guidelines Practical development skills from the laboratory work and troubleshooting Task oriented with learning attitude and Teamwork skills Fluency in oral and written English Confirmed skills of Microsoft Office is essential Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage Candidate interested/experienced in above documentation work will be preferred. 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 the 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 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 Required documents: CV/Resume Application deadline: 05.07.2025

Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times. Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, Particulate matter analysis using Malvern, PAMAS, HIAC and other relevant instrumentation techniques. etc. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers, Particulate matter analysis techniques. Shall have experience on Good documentation/laboratory practices such as ALCOA+. Experience in calibration and qualification of various analytical instruments HPLC, UPLC, GC, and other QC laboratory instruments Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control). Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards / Chemicals / Reagents / Consumables / Spares etc., required for the projects Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Must possess good communication and e-mail etiquettes. Behavioural Skills Good Interpersonal skills Self-time management Good team player Good communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 0-6 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-visible spectrophotometer, Potentiometer, Particulate matter analysis techniques and QC other analytical instruments Theoretical knowledge in Chromatography and spectroscopy technique Good documentation/laboratory practices such as ALCOA+. Able to follow work instructions and perform the tasks under the supervision of the Team leader Preparation and Maintenance of all the documents Good knowledge of MS-office (word, excel, ppt) Education M. Pharm/ M. Tech/ M.Sc. / B.Tech., B.Sc. (Analytical chemistry/Chemistry)