175 Stability Studies Jobs - Page 7

Method development & Validation ( HPLC /GC/ UV/ Potentiometer etc..) for both Solid orals and Injectables & Handling of all analytical instruments/ Equipments, SOPs prepation, SPEC and STPs prepation/ review,Stability samples analysis .

For day to day sample extractions & instrument (LCMS/MS - GCMS/MS) sequencing Roles and Responsibilities Testing of various agriculture and food products for chemical and nutritional testing by standard and in-house methods Hands on expireance in Proximate Analysis Operating the lab instruments like pH meter, weighing balance, incubator, GCMS/MS & LCMS/MS, UPLC Preparation of standard solutions Daily maintenance of lab equipment. Following good laboratory practices Following disposal process for samples & solutions as per SOP. Accurate analysis and interpretation of test results Maintenance of laboratory documents and records Validation of methods and calibration/verification of instruments Ensuring purity and validity of CRMs Conduct sensory evaluations of food samples

Functional or Technical skills 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. 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. 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. 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 0-3 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.Tech., B.Sc. (Analytical chemistry/Chemistry) with 0-3 years 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.

Subject: P&G Requirement- Management Associate to be outsourced from M/s Ashkom A] Required No. of resources: 1 No B] Job Title/Description: Associate MPD Process AMA PHC, BB C] Responsibilities: Refer the highlighted below [ additionally, refer Screen shot shared earlier under - General : Key Accountabilities] 1) To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) 2) To maintain track of on-going/work in progress CCPs /closer of change controls 3) To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. 4) Support to MPD Process/ADL technical team in making batch records & other MPD documentation. 5) QC Soft entries for report generation of various stability, Raw material samples, protocol printing. 6) Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for - Sending samples for outside testing with proper documentation 7) To participate in other tasks assigned by MPD- team members e.g., TT document review 8) Supplier qualification technical document review, 9) To liaison with RM suppliers for receipt of material qualification document, safety document & its review. D] Duration: 1 year in the beginning [ basis business need & performance may be continued further] E] Required Qualification & experience: M. pharm. Pharmaceutics F] Work Experience: 2.5 -3.5 years in the pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study managment

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

*Greetings*!! *We Are Hiring_Quality Control _ Chennai Location* *Education*- B.Sc / M.Sc *Experience* - 2 to 5 Years *Location* - Chennai *Preferable Candidate from only Pharmaceutical Manufacturing* Key Skills - handling HPLC , QMS , Raw materials and Wet Analysis For more details and to apply, please reach out at pna@softgelhealthcare.com or call 8608396077 References will be highly appreciated

The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. About the Role: The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports. Compilation of Quality control monographs describing test procedure and specification setup. Scientific analytical support for quality control, production, registration, marketing. Presentation and discussion of analytical data in local and international project teams. Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as we'll as changes and complaints. Cross-functional interface with Manufacturing Science Technology team, analytical development, production and regulatory department. Management and coordination of analytical activities at external laboratories (CROs). Support for trouble shooting activities and continuous improvement initiatives. Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Budgeting and cost control of external analytical activities. Contribution to QC/AST network teams. Management of reference substances and control samples. Essential Requirements: Minimum 10 years in pharmaceutical industry and/or analytical laboratory in GMP environment. MS Office- and other standard IT applications. External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organisation and Novartis organisation. Innovation: continuously thrives for improvements and questions processes and procedures for improvements. Reacts in a flexible and fast way on changes and challenges. Ability to analyse complex processes. Desirable Requirements: Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Language proficiency: English, German optionally. Why Novartis: you'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

Develop and optimize formulations for new and existing products Conduct pre-formulation studies, including solubility, stability, and compatibility tests Prepare laboratory-scale and pilot batches and analyze physical and chemical properties

Roles and Responsibilities Conduct stability studies, method validation, and analysis of finished products using techniques such as GC, HPLC, UV-Vis, KF, FTIR, and dissolution testing. Ensure compliance with GLP guidelines and maintain accurate records of all experiments and results. Collaborate with cross-functional teams to resolve issues related to product quality control and manufacturing processes. Develop and implement new methods for analyzing raw materials, intermediates, and finished products. Participate in method development activities to improve existing methods or develop new ones.

Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualification Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Key Responsibilities Quality Strategy & Planning Develop and implement quality control standards, procedures, and policies. Define inspection criteria and quality benchmarks. Team Management Lead and supervise a team of quality inspectors or analysts. Provide training and guidance to QC staff. Manage and supervise QC laboratory activities Use effective negotiation skills to drive alignment and resolve conflict Inspection & Testing Oversee routine inspections and testing of raw materials, in-process, and finished products. Ensure compliance with internal and external specifications and regulations. Documentation & Reporting Maintain detailed records of quality control activities. Analyze QC data and generate reports to identify trends and areas for improvement. Compliance & Audits Ensure compliance with ISO, GMP, or other industry-specific standards. Coordinate and support internal and external audits. Problem Solving Investigate product quality issues and customer complaints. Implement corrective and preventive actions (CAPA).

Job Band: Job Band 13 (JB13) Hiring Manager: Akhil Kodiyamtharappel Sadasivan Lead Recruiter: Tino Manimuthu Country: India Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential. JOB SUMMARY: - Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines. REPORTING: - Reports to Deputy Manager QC ESSENTIAL DUTIES: - Administration/Internal Communications: Responsible for completing testing as part of Chemical, Functional and incoming inspection. Responsible for Document Review and Approval Responsible for providing support to Global Quality projects. Responsible for providing support to complete gap assessments. Other duties and responsibilities Responsible for Analysis and inspection of raw materials, accessory items and finished product. Responsible for Document and Test Report Reviews and Approval Responsible for In-process Testing and water testing. Responsible for making sure that data is accurately recorded in accordance with guidelines. Responsible for reporting, trending, and presenting results. Responsible for Calibration of Glassware and Instruments. Responsible for ensuring products are complying to the established regulatory guidelines with respect to product compliance. Responsible for ensuring GLP and cGDP requirements are in place. Responsible for supporting WCM, Lean, Six Sigma projects, root cause analysis, Productivity projects. Responsible for empowering people by giving required training Responsible for qualification of analytical instruments and QC equipement Responsible for New product evaluation and stability studies. Responsible for Monthly trending of test results. Responsible for subcontractor training and audits. MINIMUM QUALIFICATION REQUIREMENTS: - Education: Master s degree in chemistry or Bachelors Degree in Pharmacy or Master s Degree in Pharmacy (Pharmaceutical Analysis / Pharmaceutics / Pharmaceutical Chemistry) Experience: 7 to 10 years of experience in Testing laboratory of pharmaceutical industry. Technical Experience/knowledge and Skills required in below. Knowledge on instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/ etc) Knowledge on performing test as per Pharmacopoeial requirements (USP/IP/EP) Data Integrity Knowledge on different type of chemical analysis Able to understand and identify key objectives across the business. Able to deal with multiple issues, tasks and priorities concurrently. Knowledge about Analytical/Microbiological test and Equipment Qualification Preferable to have Knowledge about USFDA/EuGMP requirements. Need to work in all 3 shifts including night shift on requirement. Additional Requirements Capable to work in all shifts including All three shifts (Night Shift on requirement). Have strong communication skills complimented with right technical skills to drive meaningful discussions.

Responsible and Accountable for the oversight of Quality operations and GMP compliance across the West and South EPD TPM s for, LL Systems & Contract Operations in India. Effectively monitoring the rating of TPM/LL sites Lead the implementation of quality strategy and plan in the above-mentioned sites including EQD policies implementation. Implement Quality Projects at identified TPM s from time to time. Ensure quality compliance to regulatory w.r.t. labelling, stability studies and documentation across the 4 business divisions to deliver acceptable quality products coming from LL and TPM sites to consumers on sustainable basis. Develop strategy on quality as per Abbott`s EPD requirements for the Supply Chain Organization in third party and LL manufacturing sites in applicable region. Promote Quality Management System as an important management tool with increased visibility across the business and guide the team for effective implementation at 3rd party contractors. Establish robust quality management systems through the supply network and ensure compliance. Create culture which imbibes quality as a way of working through identified trainings and awareness programs for critical LL and TPM sites. Establish and implement a process to ensure all consumer complaints/ queries are addressed as per Abbott policy in stipulated time at applicable TPM sites. Establish KPI s and analyse the same periodically to improve the compliance metrics through departmental reviews. Periodic quality reviews with COQA team. Monitoring of LL & TPM tech transfers, SAP related matters and KPMG audit compliance. Deputise for Director TPM QA as per needed Ensure development needs are identified for direct reports Ensure Quality budgets are maintained and managed for TPM QA organization Ensure the COMPETE project runs as expected, efficiency and cost saving ideas are identified, managed and implemented Participate in "Management Quality Reviews" and "Functional interface meetings". Ensure that the associated TPM s are maintained in a state of Quality and compliance and the CAPA;s arising out of the audits are closed on time.

Key Responsibilities Perform analytical testing of raw materials, intermediates, and finished APIs using HPLC, GC, UV, and other analytical instruments. Execute analytical method validation, method transfer, and verification as per regulatory guidelines. Ensure compliance with cGMP, GLP, and regulatory standards (ICH, USFDA, EU, WHO) . Maintain accurate documentation, calibration logs, and test reports in compliance with company SOPs. Support investigations, OOS, OOT, and CAPA implementation . Coordinate with QA and Production teams for smooth project execution. Contribute to laboratory upkeep, safety practices, and audit readiness.

Candidates should have good hands on Experience on HPLC, GC, Stability, Wet Lab, RM Sampling & Analysis, Documentation, Standardization of Karl fisher Titrator. Responsible for Calibration of Instruments. Can handle QMS & AMV activities Required Candidate profile Preferred immediate Joiners. USFDA preferable. Interested candidate can share CV on sachin.kapte@enaltec.com Mob.8976826875

Role & Responsibilities: Upkeep the laboratory with respect to cleaning and discipline. To follow the GLP regulations within the laboratory. To perform the method development, in process and stability activity of drug product as per the plan and priority. To record and maintain daily temperature and humidity record of laboratory in logbooks. To follow relevant safety and regulatory norms. To follow all time compliance to company policies and values. To prepare analytical data sheets as per current version of specification and Method of Analysis. To conduct project related analytical activities at Quality Control laboratory. To calibrate the instruments as per the plan or as and when required.

Job Opening: QC Chemist – Executive Level Company: Dalas Biotech Limited Qualification: B.Sc. / M.Sc. in Chemistry or related field Experience: 2 to 7 Years Instrumental Analysis using HPLC, GC, KF, UV Spectrophotometry

Principal task: Analytical Method Development by HPLC for all Project. Review the analytical method development data, validation study data and method transfer protocol and reports. Calibration of HPLC system. To maintain GLP/GDP in working environment. Preparation of analytical data and submit for review. Analytical Method Development and Validation. Responsibilities: Calibration of HPLC’s as per SOP and maintenance of HPLC Systems. Maintaining record for all analytical reports by entering all the data in raw data note book and timely release of analytical reports. Preparation & Review of analytical method validation protocol and report as per the current regulatory requirement. As per Protocol, perform the Analytical method validation of RS, Assay and Chiral for KSM, Intermediate and Finish product of compendia and non-compendia compound. Preparation & Review of Protocol & report of analytical method transfer report. Maintain records for all analytical reports by entering all the data and timely release the analytical reports to concern department.

1. Develop, validate, and optimize analytical methods for raw materials, intermediates, and finished products. 2. Perform stability studies, impurity profiling, and release testing in line with ICH and regulatory guidelines. 3. Prepare comprehensive documentation, including method development reports and validation protocols. 4. Collaborate with formulation scientists to support product development and scale-up. 5. Troubleshoot analytical methods and instrumentation, ensuring efficient lab operations. 6. Ensure compliance with GMP, GLP, and regulatory standards within ADL.

HPLC, Stability test ,

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)

13579 External Job Description Role Description Job Purpose To ensure that inspection and all related activities are carried out as per the defined quality system and only conforming product batches are released, in quick time, for packing. Daily Activities a) Getting the details about status of different batches in various Pug mills, Mixers, reactors, TSDs etc from the preceding shift Officer-Level I. b) Making a list of approved, pending batches, and obtaining any special instructions or communication regarding batches, processes, practices etc in the previous shift. c) Ensuring implementation of 5S activities on the shopfloor and QA lab. d) Ensuring the regular updation of various ledgers and log books regarding the parameters checked for batches and other tests done. e) Undertaking calibration of various instruments like color computer etc for future usage. f) Inspecting various finished products and intermediates as per the specifications and test methods laid out in the master files. g) Analyzing batch cards of finished products intermediates for observed deviations in process controls availability of data for future analysis etc. h) Coordinating with production in case of deviations w.r.t completion of batches, recording details of the same and ensuring that these do not recur in subsequent batches. i) Ensuring periodic updation of various ledgers, files as per the laid down procedures in accordance with ISO requirements. j) Looking after the smooth operating and maintenance of various instruments like colour computer, penetrometer, viscometer, gyroshaker etc. k) Making daily rounds to the shopfloor and processing floor to ensure that the activities are carried down as per the laid down procedures/systems. l) Communicating with production department regarding status of various batches, approvals, problems related to batches etc. Weekly/Monthly/Ad hoc Activities a) Getting the weekly/ monthly plan from the Planning department and checking for the availability of specifications, test methods, Master samples, and Standard shade panels. b) In case of non-availability of the above, informing Planning cell immediately and taking steps to procure the same. c) Analysing customer complaints thoroughly as per the system guidelines and handling customer queries. d) Ensuring that feedback for customer complaints goes within 48 hours for product complaints and within 24hrs for packing complaints. e) Conducting of various products cum process audits, packing audits, batching audits etc. f) Conducting Other Tests as per the required frequency. g) Ensuring that master samples are generated before one month of the expiry period. h) Ensuring that standard shade panels are procured from technical function one month before the expiry period. i) For new designs, ensuring that first three batches are subjected to other tests and sending the samples to Technical Function. Communicating the results to respective persons. j) Providing all the necessary data required for monthly report preparation. k) Ensuring that stability studies and exposure studies are conducted as per the guidelines and informing the technical function about the deviations. l) Providing the necessary support for analysis of deviant batches. m) Referring the matter to Technical function in the following cases: i. Problems in Batches, ii. Specifications, iii. Test Methods iv. New Products, v. Master Samples, vi. Standard Shade Panels etc Role Requirements / Specifications Qualifications Preffered: B.Sc chemistry Desirable: M.Sc chemistry Previous Experience - 1-3 years.

ORGANISATIONAL OVERVIEW We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities. Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly. Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team. JOB DETAILS The candidate should design and execute formulation development studies for drug product within the Process Sciences group. The role is critical to the delivery of a suitable formulation in the appropriate DP dosage form (liquid/lyo) and possessing desired physico chemical characteristics. KEY DELIVERABLES Provide technical leadership for DP formulation and lyophilization development and characterization. Strong understanding of design of formulation studies and selection of appropriate excipients for different dosage forms (liquid/lyo) and stability studies in order to design and develop suitable formulation in the appropriate DP dosage form (liquid/lyo) and possessing desired physico chemical characteristics. Perform studies for selection of primary packaging container and design/execute compatibility studies. Perform forced product degradation studies. Strong understanding of DP unit operations like freeze/thaw, filtration, filling, lyophilization Good collaboration skills with clients Responsible for authoring and reviewing technical reports related to drug product, and contribute to regulatory submissions and audits with health agencies. Contribute to publications/IP around formulations EXPERIENCE Strong understanding of design of formulation studies and appropriate excipients for different dosage forms (liquid/lyo) and stability studies Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing and packaging operations is desirable. Cross functional technical knowledge is highly desirable. Excellent oral and written communication and interpersonal skills will be desired. EDUCATIONAL QUALIFICATION Masters or Ph.D in Chemical/Biochemical Engineering or similar disciplines with 5+ years of work experience in drug product formulation development and manufacturing.

We are seeking a highly skilled and creative R&D Fragrance Specialist with expertise in Cosmetic, Skincare & Haircare Formulations. The ideal candidate will be responsible for developing innovative fragrance concepts, working closely with formulation scientists, and ensuring products meet performance, regulatory, and sensory requirements. Key Responsibilities Develop and customize fragrance formulations for skincare, haircare, and cosmetic products aligned with market trends and brand positioning. Collaborate with R&D, marketing, and production teams to create innovative and cost-effective fragrance solutions. Conduct sensory evaluations, stability studies, and performance testing of fragrance in various product bases. Maintain compliance with IFRA standards, safety regulations, and internal quality guidelines. Research global fragrance trends, raw materials, and new technologies to drive product innovation. Liaise with fragrance houses and suppliers to source unique aroma compounds and evaluate new samples. Document formulation processes, fragrance specifications, and technical reports for product approvals. Provide technical support during scale-up and manufacturing to ensure fragrance quality consistency. Required Qualifications & Skills Hard Skills: Strong knowledge of fragrance chemistry, raw materials, and blending techniques. Experience with cosmetic, skincare, and haircare formulation processes. Proficiency in sensory evaluation and fragrance stability testing. Understanding of IFRA standards, cosmetic regulations, and safety guidelines. Familiarity with global fragrance trends and market preferences. Soft Skills: Creative mindset with an eye for innovation. Excellent communication and cross-functional collaboration skills. Strong attention to detail and problem-solving abilities. Ability to manage multiple projects under tight deadlines. Education & Certifications BSC, MSC/ Cosmetic Science, Chemistry, Fragrance, or related field. Professional certifications in fragrance creation, perfumery, or cosmetic formulation (preferred). Preferred Experience 3 7 years of experience in fragrance formulation for skincare, haircare, or cosmetic products. Previous experience in cosmetic manufacturing or fragrance house R&D. Proven track record of successful fragrance launches in consumer products.

We are seeking a highly skilled and creative Flavor Specialist to join our R&D team. This role will focus on developing and optimizing flavors for oral care, skincare, and cosmetic products that meet functional, safety, and consumer preference requirements. The ideal candidate will have strong flavor chemistry expertise, sensory evaluation skills, and a passion for creating impactful consumer experiences while aligning with market trends and regulatory compliance. Key Responsibilities Develop, test, and refine flavors for oral care (toothpaste, mouthwash), skincare, and cosmetic formulations. Collaborate with R&D, formulation scientists, and marketing teams to align flavor profiles with brand positioning. Conduct sensory evaluations and consumer trials to assess flavor impact and stability. Ensure flavors comply with international regulations (FSSAI, BIS, IFRA, EU, FDA). Optimize flavor delivery in various product formats (gels, creams, liquids, emulsions). Maintain technical documentation for formulations, flavor trials, and stability studies. Stay updated on market trends and new flavor technologies to enhance product innovation. Work with suppliers to source high-quality raw materials and evaluate new flavor systems. Qualifications Education / Certifications BSC, MSC/ Cosmetic Science, Chemistry, Flavor, or related field. Certification in Flavor Creation or Sensory Science is an advantage. Hard Skills Strong knowledge of flavor chemistry, sensory analysis, and raw material functionality. Experience in flavor development for oral care, skincare, or personal care products. Understanding of regulatory compliance for cosmetic and oral care flavors. Proficiency in formulation stability testing and flavor release mechanisms. Soft Skills Creativity and innovation in flavor concept development. Strong analytical and problem-solving abilities. Excellent communication and cross-functional collaboration skills. Attention to detail and quality-focused mindset. Preferred Experience 3 7 years of experience in flavor development for cosmetic, skincare, or oral care products. Proven track record of launching successful flavored formulations. Experience working with third-party suppliers and global R&D teams.