74 Stability Studies Jobs - Page 3

Role & responsibilities Analytical data review of in-process, Batch release and stability samples & planning of activities in the Instrumentation lab Trouble shooting of HPLC & UPLC instruments, maintaining of lab as per GLP GDP practices. Audit trail verification of APLE & UPLC 1. Preparation, revision and review of SOPs, STPs, Specifications and GTPs and Worksheets related to product testing. 2. Preparation, revision and review of analytical method Validation protocols and reports related to product testing. 3. Responsible for shift schedules and test planning activities. 4. Testing, documentation, review and release of In-process, Batch release, Stability and Miscellaneous samples. 5. Responsible for testing review and release of product samples by analytical techniques like CZE, HPLC, UPLC etc., 6. Responsible for handling of OOS, OOT, Incidents, LIRs, Change controls and Risk Assessments. 7. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 8. Responsible for training of QC analysts and new joiners related to product testing. 9. Review of analytical reports and work sheets related to product testing 10. Maintenance of all QC documents related to product testing. 11. Preparation and Review of reagents and buffers. 12. Responsible for GLP compliance. 13. Responsible for usage, monitoring and verification of all kinds of Laboratory log books 14. Responsible Sample management and Material management in Quality Control. 15. Stability Management. 16. Responsible for calibrations, validations and PMP of instruments related to product testing. 17. Preparation, execution and review of reference standard qualification. 18. Responsible for procurement and verification of reference standards stock and consumption records 19. Responsible for conducting internal audit of other departments as part of GMP compliance. 20. Responsible for general cleanliness of laboratory 21. Responsible for coordinating with IT department for ensuring the electronic data backup, data retrieval of instruments related to product testing. 22. Responsible for preparation for URS. 23. Responsible for Coordinating with inter and intra departments for technical discussions. 24. Responsible for samples sending and checking of outside laboratory reports. 25. Responsible for preparation and uploading of job responsibilities for new joinee or whenever employee job role change. 26. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 27. Any other responsibilities assigned by reporting officer and HOD. Preferred candidate profile

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

Analysis of Stability and Finished products and maintain GDP and GLP . Follow compliance of current regulations and etc. Testing of Finished Products maintain all GLP document and calibration of Instrument like HPLC, UV spectrometer etc. HPLC, Stability and Working standard section incharge. And also involved in Documentation related activity. Incident, OOS, OOT and CCF initiations and investigation report throug LIR with trackwise. Qc trainings and supporting to RA.

Urgent Opening for QC Chemist Knowledge of HPLC, GC, Stability , KF, UV, validation, Documentation etc

Job Title: Management Associate MPD – AMA Contract Resource Department: MPD-BB, AMA PHC Location: Andheri East Chakala, Mumbai Position Type: Full-Time, Contractual Vacancies: 1 Job Description: We are seeking a Management Associate to support the MPD – AMA team on a contractual basis. This role involves key responsibilities in pharmaceutical documentation, data management, and coordination to ensure efficient support to formulation and analytical development teams. Key Responsibilities: Setup of Enovia DSM for formulation parts and documentation. Compilation and tracking of stability study data for review and approval in Enovia. Raise and manage Change Controls in Veeva QA system for MPD department (CCPs in scope). Maintain status trackers for ongoing/pending CCPs and ensure timely closure and action item follow-ups. Support the MPD Process and Analytical teams with preparation of batch records and other regulatory documentation. Create Coupa Purchase Orders (POs) based on verified quotations. Perform QC Soft entries for reports on stability data, raw material samples, and protocol documentation. Coordinate with the MPD lab team for: Disposal of laboratory waste. Dispatching samples for external testing with accurate documentation. Updating records for destruction of leftover stability samples. Assist in TT document and supplier qualification reviews . Liaise with RM suppliers for collection and review of material qualification and safety documents . Perform additional tasks as assigned by the MPD team. Qualifications: B. Pharm / M. Pharm from a recognized institution. Experience: Minimum 2 years of relevant experience in Formulation Development (F&D) and Technology Transfer functions in a reputed pharmaceutical company. Key Skills: Familiarity with Veeva QA, Enovia DSM, QC Soft, and Coupa Strong knowledge of pharmaceutical documentation and stability study processes Experience in Change Control and Regulatory Compliance Good communication and coordination skills Proficient with MS Teams, SharePoint, and Email correspondence

Engineer-power system studies Think bigger scale. Think higher profile. Think ground-breaking. Join WSP, and you ll be at the heart of a team of international experts all dedicated to growing and sharing their expertise, and working on projects that transform society for all of us. WSP are looking for Principal Engineer - Power System Studies with over ten years experience of overall responsibility of strong engineering design, installation, configuration testing and commissioning, co-ordination including site supervision of works with emphasis on meeting the contract requirements with respect to quality, time and budget. The key objectives of the roles are to: Power system analysis of transmission and distribution projects. Feasibility studies, masterplans, despatch studies, renewable integration, grid code reviews Preparation of Renewable generation connection schemes from distribution to utility scale generation including determining techno-economical optimum amount of renewable generation. Load flow study, fault level calculations, harmonic analysis, voltage stability and transient stability analysis on transmission, distribution, and industrial power systems, using DIgSILENT, PSS/E, PLEXOS, ETAP, CYME PSAF, ASPEN OneLiner, ASPEN database and IPSA+. Review all the Power System Studies technical submittals by EPC contractor / Developers in reference to Client s Electricity Transmission Code and International standards as applicable. Review the Power system models developed by EPC contractor specific to each study. Attend all the required meetings & address all the technical clarifications raised by EPC contractor / Developer. Attend the FAT & SAT visits to ensure all the performance criteria are met related to grid compliance requirements. The test shall be conducted with RTDS or other similar tools. Review the updated model received from EPC based on FAT/SAT reports and ensure all the grid compliance requirements are met as agreed during the detail design stage. Assist Client to incorporate HVDC model provided by EPC contractor into the TRANSCO network PSSE & PSCAD models suitable for various planning studies (steady state and dynamics). The power system studies review work shall briefly include, but not limited to the following: Reactive power capability study Grid impact study Transient and dynamic stability studies Insulation co-ordination study Switching transient study Faulted transient switching study Transformer Energization study AC/DC harmonics and flicker study AC/DC harmonic filter sizing report Harmonic impedance locus identification and analysis study AC protection relay setting coordination study Sub-synchronous resonance studies All required ETC compliance studies Wed love to hear from you if you have: Master s Degree in Electrical / Power systems Engineering. Minimum 10 years of working experience with similar capacity. Proficient with Power system study softwares like PSS Sincal, PSSE, PLS CAD, Dig silent etc. Must have experience in Power System Studies and design related to High Voltage Direct Current (HVDC) offshore projects, Specifically Voltage Source Converter technologies, Grid Impact studies, etc. Must have experience in Power system studies on Transmission and Distribution projects. Essentially having detailed knowledge related to review of contractor s drawings. People managing skill, with excellent written and verbal skills. Able to build excellent client relations through communication and multidisciplinary coordination skills Plexos Energy modelling What if we can? What if we can have work-life balance? What if we can be rewarded in ways that support our individual needs? What if we can be accepted for who we are? Here at WSP - we can! WSP recognizes that work is only one part of our lives and making time for the other things in our life is important - be that our families, our friends or ourselves. So, if working from home, working part-time or having flexible start and finish time will help with this let us know as part of your application. As well as rewarding you with competitive pay, WSP offers standard benefits including first class medical cover, paid professional subscriptions. Be you, be happy - we strive to have a friendly and inclusive culture which respects and maximizes the contribution individuals can bring to WSP. We recognise the benefits that people with varying backgrounds and experiences can bring. Here at WSP we positively encourage applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, religion or belief, marital status, pregnancy or maternity/paternity. We will interview all disabled applicants who meet the essential criteria.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring

? Job Description: ? ? We are looking for a skilled and proactive QA/QC professional with 2 5 years of experience to join our quality team. The candidate will be responsible for executing and overseeing quality assurance and quality control activities in compliance with regulatory and company standards. ? ? Key Responsibilities: ? ? Quality Control? ? Perform analytical testing of raw materials, in-process samples, and finished products. ? ? Operate, calibrate, and troubleshoot instruments such as HPLC, UV-Vis, GC, FTIR, and KF. ? ? Prepare and review analytical documentation including test reports, COAs, and calibration records. ? ? Guide and Mentor QC Executives / Trainees for analytical testing ? Quality Assurance? ? Review batch manufacturing and packaging records (BMR/BPR). ? ? Investigate and document deviations, OOS, OOT, and implement CAPA with timely closure. ? ? Review and manage controlled documents (SOPs, protocols, forms) issuance, retrieval, and archival. ? ? Perform internal audits; support regulatory audits (e. g. , WHO, ISO, etc. ). ? ? Oversee GMP, GLP, hygiene training for production and QA/QC staff. ? ? Coordinate stability studies, analyze trends, and maintain stability protocols and logs. ? ? Ensure data integrity in documentation and electronic systems. ? ? Participate in risk assessment and mitigation for quality events. ? ? Support technology transfer, scale-up, and cross-functional quality activities. ? ? Evaluate and audit vendors and suppliers as part of QA oversight. ? ? Requirements: ? ? 2 5 years of hands-on experience in analytical techniques and instruments in a regulated environment. ? ? Strong understanding of cGMP, GLP, and ICH regulatory requirements. ? ? Proficient in analytical instrumentation and documentation practices. ? ? Ability to handle audits, deviations, and quality systems independently. ? ? Excellent communication, collaboration and organizational skills. ? ? Team player with attention to detail and accuracy. ?

Role & responsibilities Independently design, plan and execute moderate to complex analytical method development experiments. Analyze the data, communicate results to clients and write technical protocols and reports Prepare method protocols, & technical reports for characterization of analytical methods based on separation techniques (HPLC, UPLC, GC), Spectro-analytical technique (Ultraviolet-Visible Spectrophotometry) and dissolution testing. Experience in developing pharmaceutical small molecules analytical chemistry methods for dissolution muti-media screening and analyzing data using compendial methods. Exposure in stability testing as per ICH guidelines. Preferred candidate profile Experience in drug product analytical development within a commercial organization. Good knowledge of three main pharmacopoeias (Japanese;, JP, US; USP and European Ph. Eur,) and ICH guidelines related to method development and validation Excellent communication (oral and written), attention to detail, effective problem solving and decision-making skills Ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude. Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Oversee and execute analytical testing of raw materials, in-process samples, and finished products. Ensure compliance with cGMP, GLP, and regulatory guidelines. Review and approve analytical data, test results, and documentation. Troubleshoot analytical instruments like HPLC, GC, UV, and FTIR. Support method validation, stability studies, and regulatory audits. Implement quality improvement initiatives and ensure data integrity

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.