460 Glp Jobs - Page 12

Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt. Ltd.! We're hiring a Quality Control Head for our client. Qualification: MSc in Chemistry, Biochemistry, or a related field Location: Vikarabad District, Telangana Experience: 5 to 8 Years Salary: 3.5 lakhs to 4 lakhs per annum Required: Male Note: Preferably with strong experience in the pharmaceutical or ethanol industry. Job Summary: We are seeking an experienced Quality Control Head to lead the QC team at our client's facility. The ideal candidate will have a strong background in analytical techniques, including Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC), and will be responsible for ensuring the highest standards of product quality and regulatory compliance. Responsibilities: Lead, manage, and mentor the Quality Control team. Develop, implement, and oversee all QC procedures and protocols. Supervise analytical testing using GC, HPLC, Spectrophotometer, and other advanced techniques. Ensure all processes and products comply with regulatory requirements and industry standards (e.g., ISO, GMP). Collaborate effectively with production teams to identify and resolve any quality-related issues. Develop and implement robust quality control measures to guarantee final product quality. Train and develop QC team members to enhance their skills and performance. Requirements: Minimum of 5 to 8 years of experience in a Quality Control role. Strong hands-on knowledge of analytical techniques, especially Gas Chromatography (GC) and HPLC. Proven experience with regulatory compliance (e.g., ISO, GMP). Excellent leadership, communication, and problem-solving skills. Proactive, detail-oriented, and able to work in a dynamic environment. (Interested candidates can share their CV to aradhana@hungrybird.in or reach us at 9959417171.) Please furnish the below-mentioned details; that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: RAMESH, QC HEAD, 6 YEARS, 30 DAYS NOTICE Name: Position applying for: Total experience: Notice period: Current Salary: Expected Salary: Thanks and Regards Aradhana +91 9959417171

Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists

Job Description Version. no.: The Job Responsibilities of the position holder are : Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time. Any other task assigned by reporting manager. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. Signatures _____________ Position holder ______________________ Authorized by JOB FAMILY: Operations Quality t

Dalmia Bharat Group is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analytical data, test results, and laboratory reports to identify deviations or issues and take corrective actions Documentation: Maintaining detailed records of test results, procedures, and observations, as well as preparing reports for documentation and compliance purposes Instrument Maintenance: Calibrating and maintaining laboratory equipment and instruments to ensure accurate and reliable measurements Safety Compliance: Adhering to safety protocols, handling hazardous materials, and ensuring a safe working environment for oneself and others Compliance with Regulations: Ensuring compliance with regulatory standards, safety protocols, and industry-specific guidelines, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) Troubleshooting: Identifying and addressing issues or deviations in chemical processes and recommending corrective actions or process adjustments

Dalmia Cement Bharat Ltd is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analytical data, test results, and laboratory reports to identify deviations or issues and take corrective actions Documentation: Maintaining detailed records of test results, procedures, and observations, as well as preparing reports for documentation and compliance purposes Instrument Maintenance: Calibrating and maintaining laboratory equipment and instruments to ensure accurate and reliable measurements Safety Compliance: Adhering to safety protocols, handling hazardous materials, and ensuring a safe working environment for oneself and others Compliance with Regulations: Ensuring compliance with regulatory standards, safety protocols, and industry-specific guidelines, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) Troubleshooting: Identifying and addressing issues or deviations in chemical processes and recommending corrective actions or process adjustments

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view. Randomly review of standard, column and chemical management logbooks. Ensure in-house compliance system. Randomly review of QMS activities (i. e. change control, incident, deviation). Maintain hygienic condition in laboratory. Follow GxP (GMP, GDP, GLP) for all processes. Ensuring proper use of Personal Protective Equipment. Thorough review of IQ/OQ and PQ of instrument/equipment. Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP. Perform internal audit of AD and provide appropriate training to AD team. Accompany the internal audit and provide appropriate response to audit observations. Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance. Tracking and monitoring of calibration planner and preventive maintenance planner. M. Pharm/ M. Sc. Chemistry

Role & responsibilities :- Perform and approve Sterility Testing using direct inoculation or membrane filtration methods as per pharmacopeial standards (USP, EP, IP, JP). Supervise aseptic testing procedures in ISO Class 5 (Grade A) environments within validated sterility testing isolators or LAFs . Ensure environmental monitoring , personnel monitoring , and media fill (ASEPTIC Process Simulation) activities are conducted and reviewed as per schedule. Approve microbiological testing results, including bioburden , endotoxin , water testing , and identification of microorganisms . Conduct investigations of microbiological OOS/OOT results and deviations , and support implementation of corrective and preventive actions (CAPA). Maintain and review sterility testing records , SOPs, protocols, and reports for accuracy and regulatory compliance. Participate in regulatory inspections and internal audits. Provide training to QC microbiology staff on aseptic techniques, gowning, sterility testing, and contamination control. Ensure microbiological methods are validated and kept up to date per pharmacopeial updates. Maintain inventory and calibration status of microbiology lab equipment used in sterility testing. Review and approve environmental monitoring data related to aseptic processing areas. Preferred candidate profile :- Attention to detail and high level of documentation accuracy. Strong aseptic technique and contamination control awareness. Analytical thinking and sound decision-making in compliance-driven environments. Ability to work independently and in a team. Good communication skills (written and verbal).

Division Department Sub Department 1 Job Purpose Develop, optimise and execute the process for APIs to ensure on time implementation within budget Key Accountabilities (1/6) Develop API process in lab by literature survey, API intermediate characterization to ensure the quality and on time implementation Carry out literature survey and route selection for assigned project Prepare and execute development strategy for the assigned project Maintain record book of experiments carried out in lab, results received from the ADL Optimize process parameters to achieve process robustness for ensuring successful completion of lab trial and lab confirmatory batches with optimised costs Support creation of new IP assets for the company by performing experiments related to innovations like new process and polymorphs Maintain and calibrate the instruments in lab as per calibration schedule Follow individual safety procedures while working in lab by following GLP Follow the green chemistry approach while conducting experiments Key Accountabilities (2/6) Prepare development report and MPG on the basis of development work (carried out in lab) in order to successfully transfer the technology in plant Prepare tech Transfer documents like MPG, pre requisite, solubility chart, development report in coordination with ROC based on process developed in lab Coordinate with manufacturing units for carrying out pilot, pre-validation and validation batches under the supervision of group leader Key Accountabilities (3/6) Conduct QbD study, carryover study, impurity (genotoxic) identification / synthesis / characterization to achieve regulatory compliance and minimize the deficiencies in the DMF filling Perform QBD studies by conducting QBD experiments in coordination with QBD team Conduct impurity profile and carryover studies, impurity (genotoxic) identification / synthesis / characterization, Key Accountabilities (4/6) Support procurement in identifying and finalising the vendors for key raw materials by performing vendor qualification to achieve on time implementation Carry out experiments required for vendor qualification on receipt of material Compare and derive trend data for shortlisting vendors by comparing materials received Key Accountabilities (5/6) Ensure compliance of checklist for stage gate and milestone meetings to complete the project within time Carry out the listed activities in the stagegate and milestone checklists within time Key Accountabilities (6/6) Major Challenges Delay in getting analytical results from ADL causes delay in the overall development of project Re-conducting experiments in cases of incorrect quality raw material being received from procurement (due to rejections) Bring to the notice of group leader in such cases, Rework as more experiments need to be performed due to changing requirements for product development, Key Interactions (1/2) Manufacturing, SCM and ADL for receiving samples and delivering results (frequently) QA and QC for quality related procedures (frequently) IP for inputs regarding literature (need basis) ROC for documentation support (frequently) Safety for safety information (frequently) Engineering for machine maintenance (need basis) Key Interactions (2/2) Vendors and suppliers for raw materials and instruments, equipment (need based) Dimensions (1/2) Process development for 4 projects (last year) Execution of process on plant for 1 project (last year) Dimensions (2/2) Key Decisions (1/2) Use of Specific reagents, solvents, reaction condition Key Decisions (2/2) Route selection for development (to GL) Specific vendor for raw materials, instruments and equipment (to SCM) Education Qualification Educational Qualifications Sc Relevant Work Experience 3-5 yrs in process R&D

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a deep commitment to data integrity and GLP/GMP principles. This role demands a proactive individual capable of troubleshooting analytical issues, leading OOS/OOT investigations, and implementing effective CAPA measures. You will collaborate closely with cross-functional teams to maintain a robust Laboratory QMS and ensure seamless method of transfer and validation processes. If you are passionate about pharmaceutical sciences and dedicated to maintaining the highest standards of quality in API manufacturing, we encourage you to apply. Job Details: Industry: Active Pharmaceutical Ingredient (API) Manufacturing Department: Quality Control Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 4,00,000 to 8,00,000 INR per annum Experience: 4-7 years Qualification: Bachelor's or Master's degree Chemistry, or a related field Employment Type: Full-time Responsibilities: Chromatographic Analysis and Data Review Perform chromatographic analysis of raw materials, in-process samples, and finished products using HPLC and GC techniques, ensuring compliance with established test procedures and pharmacopeial requirements. Review chromatographic data generated by other analysts for accuracy, completeness, and compliance with data integrity and GDP. Troubleshoot HPLC and GC systems, resolving issues to ensure reliable instrument performance. Participate in method validation and transfer activities in line with regulatory expectations. Analyze stability samples and maintain data integrity in accordance with ICH guidelines. Prepare reports summarizing analytical results and findings. Quality Control and Compliance Implement and maintain a robust Laboratory QMS as per GLP, GMP, and internal quality standards. Lead OOS and OOT investigations and implement corrective actions to prevent recurrence. Manage and document CAPA activities effectively. Ensure data integrity through robust controls and secure data handling practices. Participate in audits and address regulatory observations. Maintain accurate documentation as per GDP guidelines. Laboratory Operations and Maintenance Oversee calibration and maintenance of HPLC and GC systems. Manage lab supplies and ensure proper storage and inventory control. Maintain a clean and compliant lab environment. Train junior staff in instrumentation, methods, and data practices. Develop SOPs and contribute to continuous improvement of test procedures. Support cross-functional teams in resolving quality-related issues. Stakeholder Management and Reporting Collaborate with R&D, production, and regulatory affairs teams. Communicate analytical findings effectively for decision-making. Prepare periodic reports for management summarizing QC trends. Participate in regulatory inspections and audits. Coordinate with external vendors for analytical services. Represent the QC department in internal/external meetings. General Expectations and Past Experiences: Possess a Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field. Have 4-7 years of experience in a pharmaceutical QC lab, preferably API-focused. Demonstrate expertise in HPLC and GC, including troubleshooting and method validation. Exhibit a strong understanding of GMP, GLP, ICH, and pharmacopeial compliance. Proficiency in Empower CDS is essential. Strong skills in data review, OOS/OOT handling, CAPA, and documentation. Excellent team collaboration, problem-solving, and communication abilities.

FERRING THERAPEUTICS PRIVATE LIMITED is looking for Analyst QC to join our dynamic team and embark on a rewarding career journey Analyze data, interpret trends, prepare reports, and support decision-making through insights Develop models, work with tools like Excel, SQL, or Python Ensure data accuracy, and contribute to business optimization and forecasting efforts

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train and mentor junior staff; ensure continuous skill development within the QC team. Manage documentation including SOPs, specifications, STPs, and logbooks. Preferred candidate profile B.Pharm / M.Pharm / M.Sc in Chemistry or equivalent. 12 15 years of relevant experience exclusively in the pharmaceutical industry (OSD & Injectables) . Strong knowledge of GLP, MPCL, and finished product QC . Proven team leadership and people management skills. Experience in handling regulatory inspections and audits. Good communication and documentation skills.

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M. Pharm (Pharmaceutical Analysis) / M. Sc Chemistry Additional Information Experience level : 0 - 2 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Basic Minimum Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Education/Experience: A masters degree in microbiology Additional Information Experience level :02 years of pharmaceutical experience preferred. Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Position Summary We are seeking a candidate with knowledge of clinical trials and the end-to-end management of biospecimens. You will be an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials. Critical to this role is the ability to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS s continuous competitive advantage. Key Responsibilities Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision. Clinical Team member responsible for providing shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc. ). Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or internal systems (if applicable)). Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. Qualifications & Experience Minimum of 3-4 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues. Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Vendor experience preferred (e. g. , Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc. ). Biospecimen management experience preferred but not mandatory. Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision. Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way. Travel requirement is minimal, 0%- 5% of time, when organization requests If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

1.Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments. 2.Resopnsible for investigation of LIR (Incident / OOS/ OOE). 3.Analysed data review. 4.Analysis of Finished, In process, Process validation, Cleaning Validation samples. 5.To report any OOS/Incidence results to immediate supervisor/Head of department. Job Role : GLP Analyst Block 2 1.To perform daily verification/calibration of all quality control laboratory instruments. 2.To ensure destruction of unused solid and liquid samples, to discard left over samples. 3.To ensure all QC activities are being performed as per approved specification/ GTPs/ SOPs. 4.Laboratory chemical management. 5.Laboratory Instrument qualification.

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

Position: Senior Executive/Manager - Flow Chemistry Job Grade: G11B/G11A Function: Process Engineering Sub-function: Research Development Manager s Job Title: Sr. Manager Skip Level Manager s Title: Sr. GM Function Head Title: VP Location: Gurgaon Job Summary The position is responsible for tasks related to flow chemistry, design flow chemistry setups, transfer of technology to plant for commercial production , trouble shooting of existing tech etc. Areas of Responsibility 2-8 years of Experience in flow chemistry. Have worked on Corning, VapourTech, Chemtrix, Coflore, Fixed Bed, Plug flow reactor etc. Design flow chemistry setups. Carryout the experiments in micro reactor. Convert existing batch chemistry to flow chemistry. Basic knowledge of chemical characterization, regulatory, quality guidelines and documentation. Literature search using Scifinder, Reaxys and other tools and preparing product dossiers. Transfer technology to plant for commercial scale-up. Trouble-shooting of running technologies in plant. To prepare technology transfer documents and get audited. To support in addressing regulatory queries. To ensure the compliance by following GDP and GLP in lab. Generation of intellectual properties by publishing patent/papers. To work in Team Energetic Innovative thinking Willingness to take responsibilities Travel Estimate Travel to the plants on need basis (1-3 month / year) Job Scope Geographical Scope Across API sites (domestic) Job Requirements Educational Qualification B. Tech or M. Tech in Chemical Engineering / Ph. D. Organic Chemistry Skills Knowledge of organic chemistry and flow chemistry. Experience having 2-5 year of experience in Flow Chemistry / Continuous Synthesis Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Role & responsibilities RESPONSIBILITIES Product is maintained in constant state of validation Product history is documented and available and current since transfer from development to date Continuously improving CpK (process capability)/ Ppk (Process Performance) Degree of standardization of product process. Genotoxic and elemental impuirty assessment in all APIS Nitrosamine impuirty assessment Transport risk assessment Investigation and data analysis of Customer Complaints, Recalls, Recurring Deviations and OoS, OoE Out of Specification, Out of Expectation. Success rate of Health Authorities inspections. Completeness of Reg CMC dossier Effective CAPA. Continuously improving Yield. Technical reports executed on time and with the right expectations. Preferred candidate profile Transfer OUT process Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed. Investigations/improvement on product Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritised and monitored Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters Validation: Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications / Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts Approves both Validation Protocols and Report Testing Monograph oversight: Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content Change control: Ensure oversight of technical changes and lead end- to- end change control management related to technical issues, working cross- functionally as required. Training: Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position Regulatory Filings: Act as the interface for the site with the relevant Health Authorities for technical issues. Review and releases regulatory proposals or information required for regulatory filings. Genotoxic impuirty assessment, Nitrosamine impuirty assessment, Elemental impuirty assessment and Transport risk assessment report. Audit support: Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit Key process safety related roles and responsibilities Responsible for the safe operation of one or more processes and the appropriate training of the operators in the process. Facilitate team which carries out ZHA before introducing the process. Prepare overall plan for Integrated Management System documentation, control and its implementation within the department in close coordination with respective HODs including implementation of Olon Health, Safety & Environment system as per CHSE guidelines. As appropriate, responsible for implementation of, compliance to and governance of practices specifically prescribed to this role by the Novartis Manufacturing Manual. Perks and benefits

1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 6-7 years of experienced in FMCG company or in pharma industry.

Developing and Implementing QA Systems and Procedures: Responsible for establishing and maintaining quality assurance systems, policies, and procedures. This includes creating SOPs (Standard Operating Procedures), work instructions. Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.