175 Stability Studies Jobs - Page 5

Job Summary - Assistant Manager - Quality Control The Assistant/Deputy Manager - Quality Control is responsible for overseeing and managing all QC operations to ensure timely, accurate, and compliant testing of raw materials, intermediates, finished products, and stability samples. This role supports the HOD in planning, executing, and supervising laboratory functions and ensures adherence to cGMP, GLP, and applicable regulatory standards. Key Responsibilities: Supervision of day-to-day QC lab operations Acting as HOD designee in their absence Timely testing and release of raw materials, intermediates, and finished products Implementation of QMS and handling of deviations, OOS, OOT, and complaints Compliance with ISO 9001, FSSC, Halal, Kosher & cGMP standards Review and update of product and material specifications Validation and revalidation of analytical methods Training of analysts on SOPs, GLP, GDP, and lab techniques Execution and monitoring of stability studies Instrument qualification, calibration, and maintenance Review and approval of analytical reports and lab documentation Leading and supporting internal/external audits Coordination with QA and Regulatory Affairs departments Implementation of pharmacopeia updates and regulatory requirements Driving continuous improvement and supporting special projects Qualification : B Pharma / MSc Chemistry Experience : 7-12 Years

Job Description :- QC Executive Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Benefits Provided: 1 Free Air-Conditioned Transportation to the Factory 2 Paid Leave 3 Tea/Coffee & Canteen Facility 4 Accident Insurance 5 Provision for Bonus & Gratuity 6 Training programs for professional advancement 7 Progressive work environment conducive to personal and professional growth Job Title - QC Executive Role & Responsibility: 1.To follow and ensure Good Laboratory Practices. 2.To perform the work according to work allotment. 3.To follow good documentation practices while making entries in Documents and records. 4.Make sure that materials are appropriately tested and results are reported. 5.To perform the Initiation and review of any change related to the department. 6.Make sure that deviations and Out of Specification Investigation are investigated and solved it with CAPA. 7.To perform the Preparation and review of all SOPs related to department, Specification and test procedures. 8.Preparation and execution of validation protocol for method validation and Analyst validation. 9.SOP Review, revision and Harmonization. 10.To perform the new products analysis method, review and arrange for necessary Corrections in test procedures. 11.To perform the Analytical method, transfer activity and report protocol review. 12.Arranging AMC of Instrument and servicing. 13.To perform the Instrument spare procurement and maintenance. 14.To Review of periodic calibration of Instruments. 15.Reference Standard procurement and management. 16.Monitoring the activity of working standard preparation and managements. 17.In- house training of Analysis and training of corporate training modules. 18.Review Analyst Qualification/ certification. 19.Departmental correspondence, Internal and external Audit compliance action. 20.Co-ordination with maintenance Dept. for QC Dept. utilities and its Maintenance. 21.To Review Qualification of Laboratory Instruments Equipment. 22.Handling Change control, OOS, OOT, Incident and deviation & CAPA. 23.Monitoring stability sample analysis, Microbiology Lab record review. 24.To check pharmaceutical addendum & supplement to make necessary amendment in the specification, whenever change in the Pharmacopoeia is observed. 25.Co-ordination for SCM related activity with IT and QA. 26.Storage of Laboratory data & records. 27.Instrument Data back up, and software users rights. 28.Arranging for outside testing and calibrations and its report Review. 29.To ensure the Approval and Rejection of Raw Material, Packing Material & Intermediates products. 30.Review of analytical results/data of in-process. Intermediate, water analysis finished API and issue COA for each batch of API. 31.Trouble shooting of the QC Instruments 32.If any additional responsibility assigned by senior. 33.To ensure all QC staff do the performance under GLP 34.Any additional job responsibilities as assigned by HOD. Department :- Quality Control Number Of Positions :- 01 Experience :- 2 to 5yrs Employment Type :- Full Time, Permanent Education UG :- B.SC in Any Specialization PG :- M.SC in Any Specialization Compensation :- As per Industry norms & experience Key Skills :- QC, UV, HPLC, Analytical, Method Development, Wet Analysis, PH Meter, GLP, Stability Analysis, SOP Review

Overall responsibility of Quality Control department (Finished product, in-process, Raw Material, Packaging Material, stability etc. )and Microbiology department. Daily review /Monitoring of Quality Control activities Handling of all Quality Control related matters. In Process Control during batch manufacturing. Overall QC Data management and coordination with corporate team. Handling of Change Control Proposal, Out of Specification, Incidents and Planned Deviations etc. through CAPA track wise software. Well versed with Handling of HPLC, UV and Dissolution Apparatus etc. Preparation & Review of Analytical Method Validation/verification/CMV Protocols & Reports. In depth knowledge of ICH, PIC/S guidelines on AMV. Monitoring implementation of Good Laboratory Practices and ensuring laboratory compliance as per requirements of regulatory guidelines. Coordinate with Manufacturing/Ware house PPIC for planning of testing of required materials. Exposure of Regulatory Audits Review of QC and Microbiology Specifications, Standard testing Procure(STP) and Standard Operating Procedure Investigation of Laboratory events/OOS/OOT/Deviation. Monitoring of Stability studies for the products manufactured at the site as per respective protocols/procedure Review and approval of analytical testing/Microbiology testing reports

Functional or Technical skills JOB DESCRIPTION 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 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) 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.

We are seeking a Quality Control (QC) Manager to oversee product testing, quality analysis, and compliance with regulatory standards. The QC Manager will be responsible for ensuring the integrity of raw materials, in-process materials, and finished products. Designation: QC Manager Department: Quality Control Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry Regulatory Experience: Minimum 3-5 years in GMP, US FDA, ISO 13485, and Analytical Testing Industry/Background: Medical Device / Pharma / Lifesciences Industry Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field Employment Status: Permanent Workplace Type: On-site Minimum Requirements: Strong knowledge of analytical techniques, stability studies, and microbiology testing. Experience in handling QC documentation, test reports, and specifications. Proficiency in GMP, ISO 13485, US FDA, and MDSAP compliance. Expertise in using HPLC, GC, UV, and other analytical instruments. Experience in raw material, in-process, and finished product testing. Strong knowledge of deviation handling, OOS investigations, and CAPA. Ability to lead a QC laboratory and ensure smooth functioning of testing operations. Roles and Responsibilities: Oversee quality control operations and ensure compliance with regulatory standards. Ensure proper testing and validation of raw materials, in-process, and finished products. Review and approve test reports, analytical data, and quality records. Monitor and maintain stability studies and analytical testing procedures. Conduct investigations for out-of-specification (OOS) results and deviations. Ensure the calibration and maintenance of laboratory instruments. Coordinate with cross-functional teams to ensure product quality. Support regulatory submissions and participate in regulatory inspections.

Pre-formulation studies lab formulation development trials of solid oral Literature survey, to design strategy for the formulation of the projects Technology transfer activities to production Documentation Tech Transfer Stability study Required Candidate profile Formulation Scientist-FRD(ROW)-Rabale Tablet, Capsules experience Weekly off/Holiday:-Friday Candidates having above experience only to apply.

QC Chemist Qualification - B.Sc Chemistry/B.Pharm with 2 years of previous experience in medical devices/pharma. Tasks : IPQC, RM/PM testing, Stability studies, BMR issuance & review, Monitoring of calibration of instruments & validation of equipments

The position will be a part of RD&I organization. The employee independently executes the formulation development and allied activities for pharmaceutical/ nutraceutical products & technologies and thus supports the global healthcare business. The employee has independent project management responsibility for a quick run project in addition to the technical responsibility for different projects. This role requires advanced expertise to work with potent API such as Hormones and Anticancer drugs in order to ensure compliance with safety standards and industry regulations, aligning with our strategic goals for growth and efficiency. KEY RESPONSIBILITIES: Conduct formulations experiments, coordinate for analysis of samples and carry out the required stability studies. Troubleshoot technical problems related to the manufacturing processes and formulations independently, in order to meet the project goals. Guide fellow scientists and trainees on technical matters. Manage a Quick run innovation project independently. Communicate with the project manager(s) and other stakeholders. Presentations with due connect to the overall technical and business goals. Coordinate with analytical department for analysis of formulation samples. In-time documentation of experiments, trial reports, stability studies and other technical documents as per the standard system and operating procedures. Material destruction coordination within RCI for destruction of experimental materials quarterly with due documentation in place. Play active role in protection of IP for the organization by coordinating with IP department. Update project specific technical details in project management system periodically. Generate new technical ideas of business relevance. Execution and reporting of additional administrative KRAs as assigned. QUALIFICATION AND EXPERIENCE REQUIRED: masters in pharmacy or equivalent, with minimum 2 years of experience in carrying out formulation development and administrative activities in lab. Sound technical knowledge related to the oral drug delivery domain.

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