175 Stability Studies Jobs - Page 2

JOB DESCRIPTION Job Title: Team Lead - QC Late Phase Stability. Job Location: Syngene International Limited, Bengaluru About Syngene: Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to 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 is an exciting opportunity to play a role in the Quality control late phase stability department of Syngene. The role will provide several responsibilities of Stability Operations, stability sample management, Chamber preventive maintenance and calibration, data review, facing regulatory and client audits. Lab safety requirements, Compliance as per Syngene policy and EHSS requirement. It provides an opportunity to handle overall Stability Operations Management. Role Accountabilities Monitoring of stability chambers with ICDAS software. Acknowledge all alarms generated by the stability chambers in ICDAS software. To ensure cleanliness of the stability chambers and update relevant records Ensure yearly chamber mapping is done as per schedule. Carry out Alarm trending activity in line with the SOP. Preparation of Stability Protocols. Labelling of stability samples and initiation of stability studies in line with the approved protocol. Updation of Stability inception and pull register. Prepare stability monthly schedule and pull samples within the specified time window as per the SOP. Updation of relevant records. Receipt of Samples for both Integrated and standalone Stability Initiation. Co-ordination with relevant departments with regard to the same activity To Initiate Change control, Incidents, CAPA and Deviations (QMS documents) as applicable. To carry out destruction of reserve samples post completion of the study in a compliant manner and update relevant records. Preparation of SOP s/ IOP s for Stability Operations. Preparation of yearly calibration and preventive maintenance planners, preparation of monthly calibration schedule. Preparation of Static data where applicable. Assist in implementation of minor changes to LIMS stability module or related validation activities. To co-ordinate with E&M and Vendor for Qualification of all Stability Chambers, calibration, Preventive Maintenance and review of all related documents. Actively participate in Client, Internal and Regulatory Audits. Strictly adherence to c-GMP, GDP and data integrity procedures. Ensure and comply with EHS policies laid down by the organization. Responsible to complete assigned training on time. Responsible for timely delivery of stability projects. Ensure optimal utilization of work hours and prioritization of the activities to meet departmental commitments. Escalation of issues/ nonconformity with applicable procedures/ policies. Ensure 100% adherence to safety requirements implemented in Syngene. Participate and implement operational excellence requirements. Take necessary action with regard to QMS where required. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience: 09 to 12 Years Skills and Capabilities LIMS Labware, Regulatory and Client audit facing capabilities, Good communication skills, partnering with others, capable of thinking scientifically to address complex problems and develop solutions. Work as a team and have a collaborative mindset. Education: MSC/ B. Pharm/M. Pharm. Equal Opportunity Employer .

JOB DESCRIPTION: Pupose:Deliver formulations in defined timeframe to meet product delivery goals for I&D Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site. Core Job Responsibilities . Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation. . Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing. . Use of QbD wherever required for Product and process optimization. . Ensure proper upkeep, maintenance and calibration of the equipment. . Ensure scale up of the developed formulation works at engineering batch level. Key Deliverables: . Literature/Patent search to create drug profile . Prototype development with rationale use of excipients . Preformulation study as may be required for formulation development . Conduct 6 months accelerated stability studies to ensure stable formulation . Proof of concept studies to demonstrate BE or comparative PK as the case may be . Scale up studies at 1/10th scale or engineering batch . Technology transfer and manufacturing of Bio/Clinical batch Job Title: Jr Research Scientist Formulation Job Function: Innovation & Development Location: Mumbai (Andheri MIDC) Reporting to:Sr Group Leader Formulation Critical Success Factors: Functional/ Technical: Functional / Technical: 1. Formulation and Product Development a. Schedule and follow all the steps to deliver the drug as per QTPP b. Select the suitable polymers / excipients based on either properties or scientific rationale c. Evaluation of CQA of drug / excipients and estimate its implications for product development d. Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly 2. Design of Experiments a. Executes the experiments as per DOE to optimize product and process 3. Pharmaceutical Development Report (PDR) a. Prepares PDR as per Common Technical Document (CTD) module 3 requirements b. Complies with regulatory requirements as defined in QTPP 4. Project Management a. Is able to plan and prioritize multiple project deadlines to meet product delivery goals Education & experience: . M. Pharm/Ph. D. . 5 to 7 yrs The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Product Development DIVISION: EPD Established Pharma LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Job Description Telecom Structural Engineer Position Overview We are seeking a skilled Telecom Structural Engineer to join our engineering team. The role involves conducting structural analysis and design for telecom infrastructure including poles, towers, and RCC buildings. The ideal candidate will have strong technical expertise in load validation, building feasibility, and stability assessments, with hands-on experience in structural design tools such as AutoCAD and STAAD.Pro. Key Responsibilities Pole Load Validation: Perform detailed analysis and validation of pole structures subjected to antenna and equipment loads. Tower Load Validation: Conduct structural analysis of telecom towers (ground-based and rooftop) to verify safe load-bearing capacity for new and existing installations. RCC Building Designs: Design and review reinforced concrete structures to support telecom installations, ensuring compliance with relevant codes and standards. Antenna Loading Services: Evaluate antenna mounting feasibility and validate loading impact on poles, towers, and buildings. Building Feasibility Services: Carry out structural feasibility assessments of new and existing buildings for telecom equipment installation. Structural Stability Tests: Execute structural stability studies and provide certification reports to ensure safety and compliance. Structural Detailing: Prepare detailed drawings, reinforcement details, and structural documentation using AutoCAD. Documentation & Reporting: Develop technical reports, analysis sheets, and stability certificates for client submission. Cross-functional Coordination: Collaborate with project managers, site engineers, and clients to deliver cost-effective and reliable structural solutions. Tools & Software AutoCAD for structural drawings and detailing. STAAD.Pro for structural analysis and load validation. Microsoft Excel for data analysis, calculations, and reporting. Qualifications & Skills Bachelor s degree in Civil / Structural Engineering (Master s preferred). 2 5 years of relevant experience in telecom structural design and validation. Strong knowledge of IS codes, telecom tower design standards, and RCC design principles . Proficiency in AutoCAD, STAAD.Pro, and MS Excel . Strong analytical, problem-solving, and detailing skills. Ability to prepare professional technical reports and client deliverables. Excellent communication and coordination skills.

Pupose:Deliver formulations in defined timeframe to meet product delivery goals for I&D Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site. Core Job Responsibilities Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation. Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing. Use of QbD wherever required for Product and process optimization. Ensure proper upkeep, maintenance and calibration of the equipment. Ensure scale up of the developed formulation works at engineering batch level. Key Deliverables: Literature/Patent search to create drug profile Prototype development with rationale use of excipients Preformulation study as may be required for formulation development Conduct 6 months accelerated stability studies to ensure stable formulation Proof of concept studies to demonstrate BE or comparative PK as the case may be Scale up studies at 1/10th scale or engineering batch Technology transfer and manufacturing of Bio/Clinical batch Job Title: Jr Research Scientist Formulation Job Function: Innovation & Development Location: Mumbai (Andheri MIDC) Reporting to:Sr Group Leader Formulation Critical Success Factors: Functional/ Technical: Functional / Technical: 1. Formulation and Product Development a. Schedule and follow all the steps to deliver the drug as per QTPP b. Select the suitable polymers / excipients based on either properties or scientific rationale c. Evaluation of CQA of drug / excipients and estimate its implications for product development d. Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly 2. Design of Experiments a. Executes the experiments as per DOE to optimize product and process 3. Pharmaceutical Development Report (PDR) a. Prepares PDR as per Common Technical Document (CTD) module 3 requirements b. Complies with regulatory requirements as defined in QTPP 4. Project Management a. Is able to plan and prioritize multiple project deadlines to meet product delivery goals Education & experience: M. Pharm/Ph. D. 5 to 7 yrs JOB FAMILY: Product Development LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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

Job Description Position: Junior research scientist (JRS)/Research scientist (RS) Job Location: - Plot No. 214, Borsad - Tarapur Road, Ta: Petlad, Dist: Anand, Gujarat, India. Department: R&D / Formulation Experience: 3-6 years in Nutraceuticals Formulations. Industry: Nutraceutical / Food / Pharma Manufacturing Reports To: Manager FRD. Job Type: Full-Time Company Profile: - Pharmanza Herbal Pvt. Ltd. is one of the few companies which is focusing on standardizing and proving the efficacy of Herbal products. Our strong supplier base, fully equipped R&D facility, FDA approved manufacturing facility, infrastructure for conducting human trials as well as our formulations unit provides a one stop solution to our valued customers. Pharmanza Herbal Pvt Ltd. is one of the leading research-oriented companies, manufacturing herbal extracts used in the Ayurvedic and nutraceutical segment. Our journey began in 1997 with Pharmanza India, our group company located in Khambhat, India, where we started producing herbal extracts. While Pharmanza India primarily focuses on veterinary allopathic formulations, we leveraged its facilities to manufacture herbal products such as Garcinia cambogia, Commiphora Mukul, and Withania somnifera from 1997 to 2004. As the business expanded, and we began exporting our products to countries like the US, Japan, and Germany. Pharmanza Herbal was established in Dharmaj, India, to continue our commitment to quality and innovation in herbal solutions. The facility is certified by Food safety authority of India (FSSAI), Food and drug Administration, India (Gujarat office) with NSF-GMP International. Current certifications include ISO9001:2015, ISO22000:2018, NSF-GMP, NSF-SPORT,USP-GMP,USP Ashwagandha,Bosewelia with Kosher and Halal and USDA/APEDA organic certifications for products. Additionally, we are also certified SEDEX 4 Pillers and ECOVADIS. Job Overview: - We are seeking a highly motivated and detail-oriented Formulation Scientist with 2-4 years of experience to join our team. The ideal candidate will have expertise in formulation development and optimization, along with a strong understanding of dosage forms, excipients, and manufacturing processes. As a key member of our R&D department, you will be responsible for designing and developing solid, semi-solid, or liquid dosage forms, performing stability studies, and ensuring regulatory compliance throughout the formulation process. Responsibilities and Duties: - 1. Research & development along with optimization of formulations for Nutraceutical and Health Supplement as per the organization requirements. 2. Development of solid, semisolid, and liquid dosage forms for herbal and nutraceutical ingredients for domestic, and regulated markets like US, EU, Brazil, and Canada. 3. Ensure adherence to regulatory requirements and customer expectations during product development. 4. Collaborate with cross-functional teams, including Analytical Development, Quality Control, and Manufacturing, to ensure smooth transition from development to production. 5. Contribute to total product development activity from material procurement to stability studies and technology transfer to the manufacturing units. Troubleshooting as required during these operations. 6. Handling different equipment, performing experiments, and documenting the results in a prescribed format. 7. Pre-formulation and excipient compatibility studies, assist in research activities as instructed. 8. Preparation of literature search, patent search, prepare product development reports, stability protocol, process validation protocol, reports and SOPs. 9. Responsible for inventory management and lab management ensuring GDP during documentation and fulfilment of GLP requirements during routine lab work. 10. Troubleshoot formulation-related issues during clinical trials and commercial production. 11. Data compilations and record maintenance. 12. Any other responsibility, as assigned by management. Qualifications: - Education level: Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field Experience: 3-5 years Personal characteristics: Hands-on experience with various formulation techniques, Strong knowledge of drug delivery systems, excipient selection, and stability studies, Familiarity with regulatory guidelines (USFDA, EMA, ICH) and industry standards. Ability to work collaboratively in a fast-paced, team-oriented environment. Salary Range: - Competitive Computer Competency: -Efficient Skills: - Excellent problem-solving and analytical skills with keen attention to detail, Strong written and verbal communication skills Benefits: Competitive salary package. Subsidized food facility. Free Transportation facility from Vadodara location. Medi-claim facility. Opportunities for professional development and growth. A dynamic and collaborative work environment committed to sustainability. Join our dynamic team and contribute to the success of our mission to provide high-quality nutraceuticals and dietary supplements that positively impact people's health and well-being. If you possess the required qualifications and share our passion for quality, we encourage you to apply for this exciting opportunity as an JRS/RS in our manufacturing unit. Company Website: - www.pharmanzaherbal.com Company Email id: - hrm@pharmanza.com

Role: Manager / Senior Manager - Quality Assurance Job Location: Aurangabad (Chattrapati Sambhajinagar) At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role & responsibilities Responsible for overall Management of specification and standard test procedure which includes preparation, review and approval at site. Review and Approval of Specification and Standard Test Procedure of Raw material / Finished products. Review and Approve Method Transfer /validation and verification analytical reports and Protocols. To coordinate for analytical method transfer/validation and verification from other locations and ensure the readiness of specification and standard Test procedure. To approve or reject the Certificate of analysis for Quality Control Release. Review of the change controls. Implementation and tracking of Pharmacopeial changes in specification and standard test procedure. Implementation and tracking of CEP and DMF notification of API. Support for Analytical documents required for regulatory submission. To approve the stability study data in LIMS. To review and approve working standard and Impurity Standard Qualification Protocols & Reports. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 12+ years experience in reputed pharma Organizations. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

You are invited to join Zydus LifeSciences Ltd. at their Injectable manufacturing plant in Ahmedabad. We are currently looking to fill the following positions: 1. Production: - Staff positions ranging from Executive to Assistant Manager require candidates with a B. Pharm / M. Pharm/ B.E background and 4 to 10 years of experience in Supervising and Controlling Production areas such as Isolator, Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, and Visual Inspection. Knowledge of QMS activities is a plus. - Plant Operator and Technical Assistant roles require candidates with a Diploma or ITI qualification and 3 to 6 years of relevant experience in operating production machines like Isolator, Filling, Vial Washing, Autoclave, Lyophilizer, and Batch Manufacturing. 2. Engineering: - Executive to Assistant Manager positions in the Engineering department require candidates with a BE/ B. Tech/ Diploma background and 4 to 10 years of experience in the Maintenance of Breakdown, Instrumentation, and Calibration of Process equipment for Injectable Manufacturing Plant. - Plant Operator and Technical Assistant roles require candidates with a Diploma or ITI qualification and 3 to 6 years of relevant experience in the maintenance & operations of HVAC, AHUs, Water System, handling of breakdowns, Process maintenance, Instrumentation, and calibration of Process equipment for Injectable Manufacturing Plant. 3. Quality Control (Chemical): - Executive to Assistant Manager positions in the Quality Control (Chemical) department require candidates with a M.Sc. background and 4 to 10 years of hands-on experience on HPLC, GC, Dissolution apparatus, and UV Visible Spectrometer. Knowledge of weight analysis, stability studies for Injectable dosage forms, Bio Assay QMS, and analytical data Review is essential. 4. Quality Control (Microbiology): - Executive to Assistant Manager positions in the Quality Control (Microbiology) department require candidates with a M.Sc. (Microbiology) qualification and 4 to 10 years of experience in Injectable doses form. Experience in Media & Culture management, Sterility test, BET, M.L.T., Growth Promotion test, Bio-burden test, Water monitoring, Environment monitoring in aseptic area & Identification of environment isolates is required. - Sound knowledge of cGMP documentation and cGMP requirements is essential for all positions. If you have relevant experience, we welcome you to attend the Walk-in-interview with your updated CV, Salary Slip, CTC, Photo, and relevant documents on: Date: 2nd March 2025, Sunday Timings: 9.00 a.m. - 4.30 p.m. Location: AB Road, Near Dr. Hardia Eye Clinic, Rau, Indore Madhya Pradesh-453331, India.,

JOB DESCRIPTION Job Role: Analytical Chemistry-Analyst Department : Analytical - BGRC Job Location : Bangalore About Syngene: Syngene (www. syngeneintl. com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe 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, etc. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Managing the stability studies for individual projects and stability data analysis, knowledge on stability guidelines and maintaining the sample storage. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers Shall have experience on Good documentation/laboratory practices such as ALCOA+ Experience in calibration and qualification of 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 Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas Behavioral Skills Good Interpersonal skills Self-time management Good Team player Polite/Good Communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 3-6 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, 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. Sc. (Analytical chemistry/Chemistry) with 3-6 years Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.

JOB DESCRIPTION Job Role: Analytical Chemistry-Analyst Department : Analytical - BGRC Job Location : Bangalore About Syngene: Syngene (www. syngeneintl. com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe 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, etc. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Managing the stability studies for individual projects and stability data analysis, knowledge on stability guidelines and maintaining the sample storage. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers Shall have experience on Good documentation/laboratory practices such as ALCOA+ Experience in calibration and qualification of 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 Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas Behavioral Skills Good Interpersonal skills Self-time management Good Team player Polite/Good Communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 3-6 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, 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. Sc. (Analytical chemistry/Chemistry) with 3-6 years Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.

Role & responsibilities Perform the calibration and preventive maintenance of the instruments as per the respective schedules. Analysis of raw material / finished products / stability samples / Dissolution profiling for R&D/ Plant support. Analytical Method Development /Verification Assay, Related substances, Dissolution etc . Perform the determination of KF factor, Daily verification of Balances, pH meter, Milli-Q water system, Hot Air Oven, Refrigerator temperature monitoring. Develop/ optimize the analytical methods by Chemical/ instrument analysis Verify/ validate the analytical methods by Chemical/ instrument analysis Preparation / Revision of Specification and Method of analysis for Raw materials / Finished Product / Inactive / Excipients etc Appropriate documentation of results and calculations, preparation of SOPs, specifications and test methods. Interpret results, evaluate data, draw relevant conclusions and give timely feedback to concerned Departments. Analytical Technology transfer of analytical methods by Chemical/ instrument analysis Perform the Impurity standard/ working standard/ primary reference standards. Receiving and filling controlled copy of specifications / method of analysis / SOP / STP etc Operation of various software like Oasis LIMS, Q Edge TMS, Chromeleon etc Preferred candidate profile Qualification: B. Pharm / M.Pharm / M. Sc Experience: Minimum 2 years in HPLC Analysis Development and Validation Perks and benefits Mediclaim

As an experienced professional in the field of Analytical R&D, your primary responsibilities will include the calibration of analytical instruments, preparation, and maintenance of solutions and reagents. You will be entrusted with the critical task of analyzing development batches, stability samples, and comparative dissolution profiles. Leading the analytical method development and validation processes, along with preparation of method development reports, will be a key aspect of your role. Your expertise will be crucial in conducting drug solubility studies of active pharmaceutical ingredients, as well as executing API and excipient comparability studies. You will be responsible for the daily monitoring of temperature and humidity in the stability chamber, ensuring meticulous documentation of all Analytical R&D activities. Adherence to GLP, GDP, safety protocols, and compliance guidelines within the Analytical R&D team will be essential. Collaborating effectively with cross-functional teams (CFT) to facilitate seamless product development within specified timelines will be a key part of your responsibilities. Additionally, overseeing LER-related activities and analytical method development reports for API and FDF will be within your purview. Analyzing scale-up and PO batches, managing document issuance, maintenance, and sample submission for laboratory testing will also be part of your role. To excel in this role, you are required to have an MSc degree with 2-5 years of relevant experience. Strong expertise in analytical method development and validation is essential, along with experience in comparative dissolution profile analysis and stability studies. A solid understanding of GLP, GDP, and compliance requirements will be necessary for success in this position. Your ability to collaborate effectively with CFTs for smooth development activities and maintain a detail-oriented approach to documentation, monitoring, and reporting will be critical for fulfilling the requirements of this role.,

As a Product Development Scientist at our company, you will be responsible for executing lab batches for Solid Orals and liquid orals, which includes formulation strategy, process selection, drug excipients compatibility, lead formulation selection, stability studies, and tech transfer in accordance with applicable regulations and ICH guidelines. You will also play a key role in advancing new formulations from idea generation through development and scale-up. Your primary task will involve evaluating and implementing ICH and Quality by Design (QbD) concepts during the Product development phase. This includes considering elements such as Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Material Attributes (CMA), and Design of Experiments (DOE). To excel in this role, you should possess strong problem-solving, analytical thinking, and communication skills. Additionally, you should hold an M.Pharm degree in Pharmaceutical Sciences or Pharmaceutics and have 4 to 7 years of relevant experience in the field. If you meet the qualifications and are excited about this opportunity, please send your CV to hr@lyruslife.com with the position you are applying for mentioned in the subject line.,

As an Analytical Chemist at our leading Contract Research Organization (CRO), you will have the opportunity to assist in conducting analytical testing of samples using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer under supervision. You will play a crucial role in preparing reagents, solutions, and standards following Standard Operating Procedures (SOPs) with precision and attention to detail. Your responsibility will include accurately recording and maintaining raw data, logs, and reports in compliance with GLP/GMP standards. By ensuring proper documentation, you will play a pivotal role in meeting regulatory and internal audit requirements. You will provide essential support in method development and validation for pharmaceuticals and biologics. Under the guidance of senior analysts, you will contribute to stability studies and impurity profiling, gaining valuable hands-on experience in the field. Learning and assisting in calibrating and maintaining analytical instruments will be part of your routine tasks. Following preventive maintenance schedules diligently and promptly reporting any malfunctions will be essential in ensuring the smooth functioning of instruments. Adhering to GLP, GMP, and regulatory guidelines while performing your assigned tasks will be crucial. Your active participation in audits and commitment to maintaining compliance with safety and quality standards will be highly valued. You will have the opportunity to enhance your proficiency in analytical techniques through active participation in training sessions. Staying informed about new methodologies, instruments, and advancements in the field will be key to your professional development. We are looking for candidates with a background in M.Sc. (Analytical Chemistry, Organic Chemistry, or related field), M.Pharm, or B.Pharm with practical academic experience. A basic understanding of analytical techniques and foundational knowledge of instruments like HPLC, LC-MS, or GC is desirable. Familiarity with GLP and GMP guidelines will be an advantage. Strong analytical and critical thinking abilities, effective communication and teamwork skills, and enthusiasm for learning and adapting to new challenges are essential soft skills we are seeking in potential candidates. Joining us will provide you with the opportunity to kickstart your career in a structured training environment, tailored to help freshers transition into a professional analytical setting. You will gain hands-on experience with advanced analytical instruments and methodologies, along with clear career progression paths and professional development programs.,

You will be responsible for ensuring the quality control and assurance processes within the food manufacturing industry. This includes conducting various tests on raw materials and finished products to verify physical, chemical, and microbiological properties, as well as ensuring that they meet established quality standards. Additionally, you will need to ensure compliance with regulatory requirements such as AAFCO, FSSAI, and other relevant standards, while implementing and monitoring Good Manufacturing Practices (GMP). Maintaining accurate documentation and records related to quality control will be a crucial part of your role. This includes keeping track of quality records, online quality check reports, batch records, and ensuring all necessary documentation is in place for audits and regulatory inspections. You will also be responsible for managing food safety and hygiene practices throughout the production, packaging, and storage areas, ensuring adherence to GMP, HACCP, and ISO standards. Conducting shelf-life and stability studies on finished products, along with recommending improvements to enhance product shelf life, will be part of your responsibilities. Addressing customer complaints related to quality, investigating root causes, and implementing corrective actions will also be essential. You will assist in internal and external audits (FSSC, ISO, HACCP) and implement corrective actions based on audit findings. In terms of production and packaging oversight, you will supervise the production process to ensure compliance with quality and process standards. Conducting online quality checks to monitor critical parameters and overseeing packaging and labeling compliance will also be part of your duties. Additionally, you will maintain production and packaging records, analyze quality data, and identify trends to suggest improvements. Training workers on online quality checks, hygiene practices, and food safety standards, as well as conducting periodic quality and safety awareness programs, will be important aspects of this role. This is a full-time position with benefits including health insurance and Provident Fund. The job location is in Mangalore, Karnataka, and requires a Master's degree (Preferred) in addition to 2 years of experience in food manufacturing. A background in Microbiology or Biotechnology is also preferred for this role. The work schedule is in the morning shift and requires in-person presence at the work location.,

Role & responsibilities: The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus The candidate should have experience in running stability programs which include temperature, forced degradation studies, photo-stability studies etc. for multiple programs and should have demonstrated ability to trouble-shoot and course-correct as required in the development phase of Biosimilar drugs The candidate should have expert knowledge on product quality estimation techniques such as HPLC, CE-SDS etc that are connected to Drug Product development so that he/she should be able to understand the nuances of the data generated and relate it to the conclusions being made in formulation The candidate should have knowledge of particle characterization techniques such as DLS and should have experience in implementing such characterization techniques to drug product development. The candidate should have demonstrated experience in conducting studies for scale down model qualification and process characterization experiments associated with drug product. The candidate should be well-versed in basic statistics and should have experience in using statistical software such as JMP, Minitab etc. The candidate should have basic knowledge of regulatory guidance from USFDA, EMA etc. and should have knowledge of ensuring development is done to meet the regulatory requirement. The candidate should have years of experience in developing drug product related data for Biosimilars. The candidate should have mid-level knowledge of various container closure systems such as vials, pre-filled syringes, auto-injectors etc. that are prevalent in the market. Preferred candidate profile: Design studies for the development of drug products for conducting various types of stability studies including process characterization studies Handling of instrument calibration/maintenance issues, interfacing with Engineering and vendors for instrument maintenance so that lab is functioning smoothly Interpretation (including statistics) of data generated, preparing presentations for project meetings and presenting data to seniors Enable process development activities including filter validation, extractables and leachables Involvement in vendor selection, evaluation, legal and IPR documentation, EHS activities and any ad-hoc trainings as required by the Company; discussions with external consultants Ability to manage a team Educational Requirements: Masters in Biotechnology/Pharmacy/any other related field with 12 to 17 years of relevant industrial experience PhD in Biotechnology/Pharmacy/any other related field with 8 to 12 years of relevant industrial experience Post-doctoral research in relevant field with 2 to 3 years of relevant industrial experience

Role & responsibilities Lead and manage the stability study program as per ICH guidelines. Plan, initiate, and monitor real-time, accelerated, and intermediate stability studies for all products. Ensure timely sampling, testing, and data review for all ongoing stability studies. Maintain and review stability protocols and reports, ensuring compliance with regulatory requirements. Handle stability chambers (qualification, calibration, and monitoring) and ensure 21 CFR Part 11 compliance. Provide managerial oversight for instrument calibration, qualification, and maintenance activities in QC lab. Ensure timely availability of reagents, reference standards, working standards, and lab consumables. Support analytical testing of RM/PM/FG and ensure smooth functioning of lab operations. Perform investigation and troubleshooting of analytical issues, OOS, OOT, and lab incidents. Ensure GMP compliance in all QC stability and lab support activities. Prepare and review SOPs, protocols, and laboratory documentation. Support regulatory inspections and audits with necessary documentation and responses. Initiate and review change controls, deviations, and CAPAs related to stability and lab operations. Participate in quality risk assessments, method transfers, and method validations. Drive continuous improvement initiatives for lab efficiency, error reduction, and cost control. Implement systems for improved turnaround time (TAT) for testing and report generation. Oversee and ensure timely calibration, qualification, and preventive maintenance of analytical instruments. Ensure adequate availability and management of laboratory reagents, reference standards, and working standards. Review and approve analytical test data, protocols, and reports ensuring regulatory compliance. Support lab teams during analytical method validation, method transfer, and troubleshooting of technical issues. Train team members on LIMS usage, functionality, and best practices. Interested candidate can share their CV at Anee.Silas@otsukapharma.in

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

Role & responsibilities Experience in operation and trouble shooting of process in plant. Isolation and purification of different organic compound using column chromatographic and crystallization techniques. Optimize the process parameters, what-if studies, holding studies etc. for scale up. Investigation of OOS/OOT and stability related issues. Handled various reagents like NaH, NaBH4, Br2, BHA, n-BuLi,TMSCl, TFA,PPA, Raney Nickel, Pd/carbon & also hazardous chemicals like POCl3, SOCl2 etc. Reactions performed like Hydrogenation,Brominaion,Oxidation,Reduction and condensation. Handling of Moisture sensitive reactions. Study and understand the project requirements, identifying and collection of suitable literature. Support lab manager to prepare weekly technical reports and other project related technical documents (impurity profile tables,Plant batch data,developmental reports) Executing assigned reactions of project. • Looking after the Safety equipments management and maintaining it as per regulatory requirement in R&D lab. • Study the MSDS of each chemical using in every new project and make arrangement of Safety equipments accordingly. Handled HPLC system of Agilent technologies Ezichrome (A.04.07) and version Open Lab cds2.4 • Good in Thin layer chromatography & Column chromatography. Preferred candidate profile Perks and benefits

As a Formulation and Process Development Scientist, you will be responsible for the formulation and process development of Solid Orals, Liquid Orals, and Semi Solids dosage forms. Your main tasks will include designing protocols and development plans for new products, conducting formulation trials, and evaluating stability data to finalize formulation compositions. You will also be involved in tentative costing Bill of Materials (BOM) and trial BOM preparation for trial execution. Additionally, you will prepare supporting documents for stability studies, resolve product stability issues, and develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. Your role will also involve writing master formulas, manufacturing procedures, stability protocols, and validation reports, as well as supporting technology transfer for manufacturing processes from laboratory scale to production scale. Furthermore, you will be responsible for developing FSSAI / AYUSH, EU, and US FDA compliant Supplement Facts and Nutrition Facts labels from product formulas. You will also create and review production Master Formula records and Manufacturing batch Records. The ideal candidate for this position should have 5-6 years of relevant experience in formulation and process development. If you are a detail-oriented professional with a strong background in pharmaceutical development and regulatory compliance, we encourage you to apply for this exciting opportunity.,

You will be working as a Senior Executive in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac). Your primary responsibility will involve reviewing Raw Material, Packaging Material, In-process, Finished product, shelf life specification, and relevant Method of analysis. You will authorize the Testing worksheet and approve analytical data of various materials in LIMS. Additionally, you will ensure compliance with Good Laboratory Practices and review analytical method validations, transfers, and verifications. Your role will also include handling, storage, withdrawal, and reconciliation of stability samples, reviewing stability study reports, verifying outside laboratory samples, and ensuring proper documentation of Change Control, Deviation, CAPA, and other quality investigations. You will be responsible for initiating departmental reports, reviewing qualification and calibration documents of QC instruments, and preparing/reviewing stability schedules and reports. Participation in regulatory audits, responding to customer queries, handling Oversight observations, and providing Quality index data will also be part of your duties. You will oversee the calibration, qualification, and maintenance of equipment, review alarm logs and trends, and monitor Critical Quality Attributes. To qualify for this position, you should have a B.Sc./M.Sc./B.Pharm/M.Pharm degree with 5 to 10 years of experience, including at least 2 years at Zydus. Experience in an injectable plant is essential. Your CV can be sent to Garima.G.Jha@ZydusLife.com or HardikA.Bhatt@ZydusLife.com.,

Role & responsibilities 1. Investigation & handling of stability related OOS/OOT. 2. Handling of Stability Chamber Management. 3. Review of analytical data related to stability. 4. Review and approval of stability summary reports for the Dossier submission. 5. Preparation and Review of stability protocol and report. 6. Approval of SOPs in DMS. 7. Evaluation of stability data, require for dossier submission. 8. Timely compilation of stability summary report Skills and Competencies: Strong knowledge of GMP, GLP, SOPs, and regulatory requirements. Excellent analytical and problem-solving skills. Strong attention to detail and organizational skills. Effective communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office Suite and quality management software. Preferred candidate profile

As a Manager R&D Nutraceuticals Products at Mosaic Wellness, you will play a crucial role in leading the development of new formulations, with a specific focus on powders, premixes, and nutri-mixes. Your responsibilities will include formulating innovative nutraceutical products, ensuring regulatory compliance with FSSAI regulations and other quality standards, sourcing and evaluating high-quality raw materials, optimizing manufacturing processes, and collaborating with cross-functional teams for successful product launches. Additionally, you will be required to stay updated with industry trends, new ingredients, and scientific advancements, while maintaining detailed documentation of formulations, trials, and regulatory approvals. To excel in this role, you must possess proven expertise in nutraceutical product formulation, particularly in powder-based products. A strong understanding of FSSAI regulations, labeling requirements, and food safety guidelines is essential. Hands-on experience in product testing, sensory evaluation, and stability studies will be beneficial. Your ability to troubleshoot formulation and production issues, along with excellent project management and leadership skills, will be key to your success. Effective communication and analytical abilities are also required for this position. This position is based in Thane and requires a qualification of B.Tech / M.Tech in Food Science/Nutrition along with 5-8 years of relevant experience. If you are a highly skilled and innovative professional looking to drive projects from concept to commercialization in the nutraceutical industry, we invite you to join our dynamic team at Mosaic Wellness and contribute to helping individuals lead more fulfilling lives surrounded by wellness and grace.,

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

Dear All, We are conducting Walk-In Interview on 29th August 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: Validations - 4-5 Years of experience in Process and Cleaning validations and equipment qualifications Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, GC and Dissolution instruments GLP - 2-4 Years of experience in management of working and reference standards, HPLC, GC and RS. Material Science Lab - 3-5 Years of experience in XRD, TGA, DSC and ICPMS 2-5 Years of experience in Nitrosamines and NDSRI's and LC-MS Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100