1782 Gmp Jobs - Page 48

Roles and Responsibilities Conduct quality analysis of raw materials, in-process samples, finished products, and stability studies to ensure compliance with specifications. Prepare BMRs (Batch Manufacturing Records) for new batches and review them before release. Perform microbial testing on raw materials, bulk samples, and finished products using standard methods like MLT (Microbial Limit Test). Ensure proper documentation of all quality activities, including test results, observations, and actions taken. Collaborate with cross-functional teams to resolve quality issues related to product development, manufacturing processes, or packaging.

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

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

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Qualifications: M.Sc./ B.E - B.Tech (Chemical Engg.) •1 to 4 years of experience. •Experience in handling critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. • • Job Responsibilities: Ensure that the products are manufactured as per the cGMP. Maintain documentation as per regulatory authorities requirements like change control, and deviations. Highlight technical problems and take corrective actions. •

Key Responsibilities: Conduct QA audits and prepare reports. Implement SOPs for QA testing. Coordinate with operations and production teams. Maintain records for compliance and certification. Requirements: Experience with QA tools, documentation, and standards (ISO/GMP/etc.). Good analytical and observation skills. Familiarity with industry-specific QA processes.

Key Responsibilities: Develop and validate analytical methods using HPLC, UV, IR, and GC. Prepare protocols and reports for method development and validation. Perform stability studies and sample analysis for new products. Maintain instruments and lab notebooks as per SOPs and GMP guidelines. Coordinate with formulation development and QA teams. Requirements: M.Sc. / B.Pharm / M.Pharm in Chemistry/Pharmaceutical Sciences. Knowledge of ICH guidelines and regulatory documentation. Hands-on experience with chromatographic techniques and software. Analytical Method Development of Assay, Related Substances, Residual Solvents & Dissolution Test Methods with Literature Search & Report.

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Inspect raw materials, in-process, and finished products. Perform quality tests and measurements. Record and report inspection results. Identify defects and coordinate corrective actions.

Role & responsibilities Trainee Production Chemist Preferred candidate profile B.Sc or M.sc 2024-25 passout candidates willing to work in Production Departmant only can apply .

Roles and Responsibilities Responsible for Analytical Method Validation. Responsible for HPLC/GC instrument handling. Responsible for Daily review of Analytical balance and Daily Temperature monitoring. Responsible to follow analytical procedures and generate online raw data. Responsible for Stability Studies and Analysis. Responsible to operate and analyze of raw materials, In Process, cleaning samples, samples for vendor qualification, Stability samples, standard and Finish product Samples and instrumental method (HPLC / UPLC / GC) and to perform analysis of process validation. Responsible for Daily verification of analytical balance and daily temperature monitoring. Online entry in logbooks of instrument, column, working standard, chemical inventory whenever use. Responsible for in process data review in night shift. Finished product sample receive, entry taken in register and maintain daily status. Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area. Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature. Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis. Responsible to perform calibration and maintain its records. Responsible to Prepare and maintain record of finished product. Responsible to maintain record of chemicals, glass wares and other lab items of department. Responsible for cleaning, maintenance, and daily calibration of specified instruments. Responsible to maintain records and qualification of primary standards, reference standards and working standards. Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification and to investigate the OOS (Out of specification) or OOT (Out of trend)if found and Responsible for maintaining QMS related documents. Responsible to follow various EHS (Environment Health and safety) guideline and use appropriate PPEs (Personal protective equipments) . . Desired Candidate Profile Candidate Should be from Pharma background Candidate Should have excellent knowledge of ICH Guidelines Prefer Who can work in a shift and willing to relocate in Navsari, Gujarat Candidate should have Work Accuracy.

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

Job Description To ensure all the products manufactured and distributed by the bottling operation conform to the specifications through assurance of processes from supply to consumer. The QAE supports the identification, planning, documentation, and management of the practices, activities and resources needed to meet quality goals and objectives in a manner that enables management to assess quality performance. Job Responsibilities Responsibility for all quality management, and quality assurance activities in the bottling operation. Responsibility for adherence to Company guidelines and requirements in the supply, manufacturing and distribution processes. Responsibility for the conformance to specifications of the finished goods leaving the plant. Responsibility to monitor, assess and improve process capabilities in the plant Responsibility for conducting the required tests on raw materials, packaging materials, WIP and finished product at the specified frequencies. Responsibility for availability and calibration of inspection and testing equipment and chemical reagents. Responsibility for process control of the final syrup, water treatment Responsibility for raw material, ingredient and product identification and traceability. Responsibility for the implementation of GMP in the plant. Responsibility to document, implement and monitor a quality assurance system in accordance with the KORE Requirements. Desired Candidate Commitment to Excellence Teamwork Planning and Execution Influencing Knowledge of the Business

Job Summary: The Manager - DT Validation Testing is a key role responsible for defining, maintaining and optimizing the Quality Management System (QMS) framework in the context of all DT Systems Project execution. The role will lead a team focused on validation documentation, development and execution of protocols along with strategic planning for complaint computerized application operations in a regulated Pharmaceutical GMP environment. Key application areas include enterprise ERP (SAP), MES, Laboratory and Digital Applications. Collaborates with key stakeholders like Digital Quality Assurance DT leadership to ensure DT Systems are compliant with regulatory requirements and internally approved processes like change control. Essential Duties and Responsibilities: Manage and lead Computer Systems Validation team within DT and accountable for ensuring computer system validation documentation for process regulatory compliance including GxP, EU Annex 11 21 CFR Part 11. Responsible to implement risk-based computer system validation methodology with emphasis on risk identification, assessment and mitigation controls. Guide DT team members on best practice regarding good documentation procedures related to cGMP and other regulatory requirements. Develop and maintain computer system validation plans, qualification test protocols, IQ/OQ protocols, traceability matrices, SOPs/SOIs, Controlled Forms and all other documents within the scope of System Development Life Cycle (SDLC). Participate Lead in project teams to create, review, and manage documents as part of the delivery of the project overseeing the execution of validation plans validation documents. Participate lead system audits which impact cGMP operations. Ensure CSV Training material stays current and training of employees, temps and consultant to ensure compliance with our internal process and external regulations. Collaborate with Digital QA to ensure documentation requirements are effectively communicated, understood, and met, and that the governing procedures are followed. Coaches, trains, develops, motivates, and evaluates Validation team members to enable their capabilities and accomplish the department s priorities. Attracts, develops, engages, and retains talented individuals to achieve current and future business goals. Ensures team members have access to training, coaching, and mentoring to thrive in their respective roles and enhance professional development. Education and Experience: Education: Requires Bachelor s degree in science related field, or Information Technology Experience: 8-12 years of experience in pharmaceutical validation of software applications, quality assurance, cGMP manufacturing. Preferred but not required: Agile Scrum Certification, ITIL Knowledge, Skills and Abilities: Deep expertise, understanding and knowledge of Computer Systems Validation in a regulated GMP environment for process and software. Strong experience in SAP ERP implementation, auditing validation requirements along with working knowledge of digital applications, IoT etc. Understanding of business processes, controls frameworks, compliance and regulations for cGMP. Working knowledge of regulations for electronic systems validation and data integrity (eg 21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance) Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment. Working knowledge of different tool sets like HP ALM, JIRA, DevOps, MasterControl for validation purposes. Able to be aware of all relevant SOPs as per company policy relative to the position as applicable. Self-motivated, high work discipline, pragmatic approach while able to enforce mandate, excellent communication people skills, strong service and support orientation. Physical and Travel Requirements 10-15% travel, including global travel. Prefer to work 12:00 Noon - 9pm IST. Willingness to work outside of these hours as needed. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account . Summary Develops, implements and maintains methods, operation sequence and processes in the manufacture or cleaning of parts, components, sub-assemblies and final assemblies. Estimates manufacturing cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations. Solid understanding of metallurgy, chemical mixtures and strict adherence to employee safety. Job Description Varex Imaging , headquartered in Salt Lake City, USA, is a leading innovator, developer, and manufacturer of X-ray imaging component solutions, which includes X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. Your Role - Ensure work area is meets established cleanliness and safety standards. Gather parts and fixtures and assemble as per product -specific work instructions. Mix, heat, monitor, and dispose various chemical mixtures including acids, alkaline, solvents, and detergents. Clean and prepare parts used on X-ray assemblies. Familiarity with metal plating and chem process. Mask and crohone glass components. Vacuum brazing, hydrogen firing, and outgassing of parts and components used in the manufacture of x-ray tubes. Perform acceptance test to ensure assembly meets specifications. Record test data per GMP. Perform daily maintenance. Perform basic equipment troubleshooting. Train new operators on braze and furnace process. Proficiency in creating, reviewing, and editing of relevant technical documents. Utilizes good time management skills for on-time delivery of assignments. Manages projects of moderate scope as assigned. Organizes and conducts meetings. Documents work/deliverables according to the company standards and industry regulations. Normally receives little or no instruction on day-to-day work; general instructions on new assignments. Your Profile... Bachelors degree in metallurgy or chemistry (or equivalent experience) and 5 years of related experience or masters degree in metallurgy or chemistry with 3 years of related experience. What we offer A unique opportunity to become part of growing organization in India being part of a global market leader in Xray imaging components. Excellent development potential. An international work environment with global teams collaborating on various projects across several countries. Competitive compensation package including participation in Varex incentive plans. Corporate Health Benefits. Additional benefits will be added as we grow. Time Type: Full time Job Type: Regular Work Shift: N/A Pay Rate Type: Salary

Job Summary: The Production Specialist in the dairy industry is responsible for overseeing and optimizing daily operations in milk and dairy product processing. This role ensures production targets are met efficiently, hygienically, and in compliance with quality and safety standards. Key Responsibilities: Supervise and monitor daily production activities including milk reception, pasteurization, homogenization, and packaging. Ensure adherence to Good Manufacturing Practices (GMP), HACCP, and other food safety and quality systems. Coordinate with Quality, Maintenance, and Supply Chain teams to ensure smooth operations. Monitor key production parameters (yields, losses, efficiency) and drive improvements. Maintain accurate production records and documentation. Implement and support continuous improvement initiatives (lean manufacturing, 5S, Kaizen). Ensure optimal utilization of manpower, machines, and materials. Support the commissioning and validation of new equipment or processes. Train and guide production operators and staff on SOPs and safety practices. Troubleshoot operational issues and escalate unresolved problems. Qualifications: Bachelor s degree/Diploma in Dairy Technology, Food Technology, or related field. 1-5 years of experience in dairy processing or production (milk, curd, paneer, ghee, etc.). Knowledge of food safety standards (FSSAI, ISO, HACCP, etc.). Strong analytical and problem-solving skills. Proficiency in MS Office and ERP systems (SAP preferred). Good communication and team coordination skills.

Experience Key Responsibilities: Hands-on experience in aseptic processing of biological/pharma products, including sterile filling, sealing, and packaging. Skilled in operating aseptic equipment and ensuring compliance with GMP, GDP, ISO 13485, and Health Safety standards. Maintains strict hygiene protocols and controlled sterile environments. Proficient in environmental monitoring, aseptic area upkeep, and contamination control. Accurate documentation of batch records, QC logs, and processing reports. Strong foundation in microbiology and pharmaceutical standards, backed by B.Sc./M.Sc./B.Pharm/DMLT qualifications. 1-4 years of industry experience in aseptic manufacturing and sterilization.

Quality Control Executive Job Location: Sikandra, Agra Job Description:- Responsible for ensuring that products meet established standards of quality including reliability, usability, and performance. The Quality Control Executive plays a key role in maintaining the companys reputation by identifying and resolving production issues, improving processes, and ensuring regulatory compliance. Job Duties and Responsibilities:- Monitor and inspect raw materials, in-process items, and finished products to ensure compliance with quality standards. Conduct routine and non-routine inspections and testing to ensure product integrity and compliance. Maintain accurate records of inspections, test results, and corrective actions taken. Coordinate with production and engineering teams to resolve product quality issues and implement corrective and preventive actions (CAPA). Review specifications and standards, and ensure products are manufactured accordingly. Prepare and present quality reports, analysis, and trends to management. Calibrate and maintain quality control equipment and instruments. Ensure compliance with internal procedures and regulatory requirements (e.g., ISO, GMP, FDA). Participate in audits and help prepare documentation for quality certifications. Contribute to continuous improvement initiatives and lean manufacturing projects. Job Requirements:- Strong attention to detail and accuracy. Excellent analytical and problem-solving skills. Ability to interpret technical specifications, blueprints, and quality standards. Good communication and teamwork skills. Proficiency in Microsoft Office (especially Excel) and familiarity with quality management systems (QMS). Ability to work independently under minimal supervision. Understanding of quality control tools and statistical techniques (e.g., SPC, Six Sigma basics). Preferred:- 13 years of experience in a manufacturing or quality control role. Experience in industries such as pharmaceuticals, FMCG, food and dairy industry Certification in quality management (e.g., Six Sigma Green Belt, ISO 9001 Lead Auditor) Education:- Bachelors degree in Science, Engineering, Pharmacy, or any other food related specialization Key Skills:- Advanced Excel, Quality assurance and control techniques, Hardworking, Time management, Punctuality, problem-solving, Documentation and reporting, Organizational skills, Adaptability

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

operation of Granulation, Coating, Compression and Filling machines. Prepare tablet & capsules as per BMR Maintain GMP documentation Ensuring daily cleaning activity, machine preventive maintenance as per schedule. Knowledge of GMP, SOPs Ability to work in shifts

Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Job Description Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelors degree

Job Overview As a Peptides Production Executive, you will be responsible for learning and assisting in the production of peptides according to established protocols and quality standards. This position is designed to provide hands-on training in peptide synthesis, purification, and related processes. Key Responsibilities: Understand and follow standard operating procedures (SOPs) for peptide synthesis. Assist in the preparation of reagents, solutions, and equipment for peptide production. Execute peptide synthesis under the guidance of experienced personnel Learn and perform purification techniques such as HPLC, chromatography, and filtration. Assist in maintaining accurate records of production and testing activities. Follow Good Manufacturing Practices (GMP) and safety guidelines. Learn to operate and maintain peptide production equipment. Report equipment malfunctions or abnormalities promptly. Maintain accurate and detailed records of all production activities. Compile data and assist in preparing production reports. Communicate effectively with team members and supervisors. Contribute to the identification and implementation of process improvements. Provide feedback on procedures to enhance efficiency and quality Attend training sessions to enhance knowledge and skills. Actively participate in professional development opportunities. Experience Min 1 year experience in peptides Production Competencies Masters/Bachelors degree in Chemistry or a related field. Basic understanding of peptide synthesis principles is a plus. Strong attention to detail and commitment to quality. Ability to work in a team-oriented environment. Good communication and interpersonal skills. Willingness to learn and adapt to new processes. Qualifications Masters/Bachelors degree in Chemistry or a related field

Summary Independent Project work less complexity, e. g. early phase projects. Lead or support smaller and less complex projects or support more complex projects with mentoring. Higher complex routine tasks e. g. failure investigations and deviation, change controls etc. Manage projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. Ensure that compliance with cGMP is maintained in TRD. About the Role Key Responsibilities Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility Write review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables. Manage project related activities (e. g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility. Support Project management functions as a project team member. Provide support to TRD line functions in GMP related topics as per area of responsibility. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc. ). Minimum Requirements: Masters, Bachelor/Technician (> 5 years pharma) Fluent English required (oral & written) Good skills in site (local) language desired. Good knowledge of cGMP, working knowledge in technical development, production or QA. Sound scientific, technical and regulatory knowledge. Good organizational and decision-making skills. Good and proven ability to analyze and evaluate cGMP compliance. Commitment to Diversity and Inclusion: Accessibility and accommodation Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary Lead and manage a team within the global TRD QA Compliance organization, responsible for driving compliance activities and projects across TRD, and providing compliance-related services from a centralized location to all TRD sites with GMP capabilities (testing and/or manufacturing). Supports local compliance teams at TRD sites in accordance with their needs and the strategy and objectives of the global TRD QA and TRD QA Compliance organization and drives aligned compliance strategies across sites. Develop strategies for compliance-related projects, processes and tools in alignment with relevant stakeholders from TRD, TRD QA, and other compliance units within Novartis. About the Role Key Responsibilities Lead and manage the team, budget and resources to meet defined objectives. Ensure timely and proactive communication of any issues or challenges to next-level manager. Develop team members ensuring their readiness to drive and support compliance activities in alignment with the TRD QA strategy and objectives. Active member of TRD QA Compliance Network, presenting compliance topics, assisting local compliance teams with issues resolutions, simplifying processes and ensuring excellence in the services provided. Ensure and facilitate active involvement of other team members. Represent TRD QA in global and/or cross-functional compliance related projects, networks and initiatives, ensuring appropriate oversight with strong quality guidance, scientific and technical expertise. Develop or contribute to the strategy of compliance-related projects, processes and tools, including contingency planning and risk assessment as required. Ensure that the strategy implemented aligns with TRD QA strategy and objectives, and complies with cGMP guidelines and internal procedures. Ensure timely communication of the overall project strategy, key issues, and other critical topics to management, project lead, and relevant team members. Proactively manage compliance-related interactions between TRD QA and other stakeholders within TRD and/or Novartis (e.g., RDQ, Global Quality). Closely collaborate with TRD business compliance roles (e.g., GMP officers) and drive alignment across sites. Coach, guide and mentor stakeholders outside TRD QA Compliance organization. Key compliance accountabilities include support to documentation management, quality monitoring, and involvement in projects and life-cycle activities related to compliance IT tools. Minimum Requirements: M.Pharm/ Masters in science 10-14 years of experience Commitment to Diversity and Inclusion: Accessibility and accommodation Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally: