279 Glp Jobs - Page 2

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

Job Title: Senior Specialist, Microbiology Location: Vadodara Job Model: Office Role Purpose of the position: Purpose of this position to maintain and continually improve the quality of products, processes & quality systems to provide right quality and services to the customers. Supports the implementation and execution of the quality, food safety, cleaning, and sanitation management systems within DSM-F HNC Premix Ensure the smooth operation of the Microbiology instruments for daily sample analysis Responsible for the calibration and preventive maintenance of the microbiology instrument and equipment as well as coordinating with the supplier/vendor of the equipment in case of breakdown and Preventive maintenance. Maintains the master equipment list and ensures that the performance verification methodologies conform to some recognized standards and the equipment is operating under validated specifications. Ensure that the units are operating according to specifications, Ensure that appropriate inventory of consumables are maintained for lab operations. Responsible for test method development and transfer, qualification of test methods and new laboratory instruments according to Pharmacopeia/In house/ ISO methods and Customer requirement any failure investigation of test method/procedure of Instrument. Assists the QA/QC Manager in maintaining the QMS microbiology and FSSC 22000 system implemented in the plant. This includes reviewing and improving on the existing process, procedures and instructions. Ensure that lab operations are carried out as per good laboratory practice (GLP). Key responsibilities: Ensure the smooth running of the Microbiology laboratory RM, PM and FG analysis are done as per their specification. Culture Maintenance. Environmental Monitoring. In-charge of the calibration and Preventive Maintenance of instruments and equipment to ensure good quality of Microbiology results. Preparation and updating SOP regarding microbiology standard methods. Source and recommend new test instrument when required and carry out qualification (IQ, OQ & PQ) of the instrument with the vendor so as to put it to use for routine testing in shortest time possible. Maintain technical data, generate reports and findings. Write relevant instrumental or procedural SOPs for the work operations. Assist the QA Manager to review and improve Microbiology procedures and instructions related to the ISO QMS and FSSC 22000 standards/LOP/SOP. Calibration and validation of Microbiology equipment. Risk assessment Microbiology Ensure that plant EMP programme is thoroughly implemented. Ensure Plant Environmental contamination incidents are investigated thoroughly and support to improve overall hygiene standards. Ensure that DSM cleaning and sanitation standards are adhered across the site. Support region for Hygiene related investigations and serve as a key resource. Conduct shop floor Gemba walks and suggest areas for improvement for hygiene/ sanitation. Actively involve in cleaning validations and verifications. Look for opportunities of cost savings in sanitation practices. Responsible for actively participating in Change management (MOC) risk assessment related to Hygiene/ sanitation. Conduct regular trainings to shop floor team on cleaning and sanitation standards. Escalate Food safety risk indicators if any from time to time to the senior management and prevent food safety risks. Keep himself/herself abreast of latest hygiene/sanitation standards and implement best in class standards. Conducts staff training of site cleaning and sanitization procedures. Oversees & monitors housekeeping and cleaning programs. Performs daily audits of manufacturing and production to identify micro risk areas, clean design defects, and proper adherence and execution of C&S procedures. Oversees teardown and re-assembly process from a hygienic perspective. Participates in company continuous improvement initiatives by seeking out improved ways to clean and sanitize more efficiently & effectively. Coordinates with other operational units to maintain compliance and perform. Communicates with all sites in the region and globally to ensure consistency and sharing of best practices.

Long Description 1 Exposure to perform the testing of Inprocess, Finished product, Stability and Cleaning validation samples etc. 2 Having knowledge of Analytical Instruments to perform the testing by HPLC, GC, UV, IR, KARL FISCHER etc. 3 Having Analytical testing skills to perform the MDI/DPI Products test like Assay, APSD, DDU, RS, Spray Pattern, FPM and physical testing etc. 4 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation. 5 Exposure of Stability sample management & Regulatory Audits. 6 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 7 Knowledge of GLP and Good documentation Practices. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Pharmacy Work Experience 5 to 8 years

Job Description Summary Are you ready to make a significant impact in the world of Pharmaceutical Diagnostics (PDx)? Join our dynamic PDx IT team as a Senior Enterprise Applications Engineer! In this pivotal role, you will collaborate closely with our Quality colleagues to shape technical roadmaps and implement technology solutions in a cost-effective way which aligns with strategic roadmap that helps achieve business objectives. Job Description Essential Responsibilities: Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH). Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations. Translate unstructured or ambiguous requests into actionable technical requirements through problem decomposition and planning. Prioritize continuously in accordance with the understanding and validation of customer problems and needs. Stay updated with industry trends and regulatory changes to ensure compliance and best practices. Lead the implementation of new IT technologies and methodologies to enhance efficiency and accuracy. Own the short-term product roadmap and its integration into a larger application or strategic roadmap. Strong written and verbal communication skills. Basic Qualifications: A Bachelors Degree in Computer Science or STEM Majors (Science, Technology, Engineering and Math). A minimum of 6 years of relevant professional experience working in the Pharma or IT Industry including experience with Salesforce development activities. Proven experience in Salesforce development (Apex, Visualforce, Lightning Components, Flows). Hands-on experience with Salesforce architecture and integration patterns. Experience with Salesforce-based QMS platforms such as Trackwise Digital or Salesforce Health Cloud. Familiarity with Salesforce DevOps tools and CI/CD pipelines. Expert understanding of analysis & design and system architecture concepts. Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11. Familiarity with audit trails, electronic signatures, and validation documentation. Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues. Desired Characteristics: Experience implementing Trackwise Digital on Salesforce platform. Understanding of QMS processes such as CAPA, Deviations, Change Control, and Audits. Ability to configure and customize Trackwise workflows and reports. Experience with Cloud technologies, Java, SQL, Integrations, API Experience working in remote / global teams. Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies. Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Relocation Assistance Provided: No

Job Title: Senior Specialist, Microbiology Location: Vadodara Job Model: Office Role Purpose of the position: Purpose of this position to maintain and continually improve the quality of products, processes & quality systems to provide right quality and services to the customers. Supports the implementation and execution of the quality, food safety, cleaning, and sanitation management systems within DSM-F HNC Premix Ensure the smooth operation of the Microbiology instruments for daily sample analysis Responsible for the calibration and preventive maintenance of the microbiology instrument and equipment as well as coordinating with the supplier/vendor of the equipment in case of breakdown and Preventive maintenance. Maintains the master equipment list and ensures that the performance verification methodologies conform to some recognized standards and the equipment is operating under validated specifications. Ensure that the units are operating according to specifications, Ensure that appropriate inventory of consumables are maintained for lab operations. Responsible for test method development and transfer, qualification of test methods and new laboratory instruments according to Pharmacopeia/In house/ ISO methods and Customer requirement any failure investigation of test method/procedure of Instrument. Assists the QA/QC Manager in maintaining the QMS microbiology and FSSC 22000 system implemented in the plant. This includes reviewing and improving on the existing process, procedures and instructions. Ensure that lab operations are carried out as per good laboratory practice (GLP). Key responsibilities: Ensure the smooth running of the Microbiology laboratory RM, PM and FG analysis are done as per their specification. Culture Maintenance. Environmental Monitoring. In-charge of the calibration and Preventive Maintenance of instruments and equipment to ensure good quality of Microbiology results. Preparation and updating SOP regarding microbiology standard methods. Source and recommend new test instrument when required and carry out qualification (IQ, OQ & PQ) of the instrument with the vendor so as to put it to use for routine testing in shortest time possible. Maintain technical data, generate reports and findings. Write relevant instrumental or procedural SOPs for the work operations. Assist the QA Manager to review and improve Microbiology procedures and instructions related to the ISO QMS and FSSC 22000 standards/LOP/SOP. Calibration and validation of Microbiology equipment. Risk assessment Microbiology Ensure that plant EMP programme is thoroughly implemented. Ensure Plant Environmental contamination incidents are investigated thoroughly and support to improve overall hygiene standards. Ensure that DSM cleaning and sanitation standards are adhered across the site. Support region for Hygiene related investigations and serve as a key resource. Conduct shop floor Gemba walks and suggest areas for improvement for hygiene/ sanitation. Actively involve in cleaning validations and verifications. Look for opportunities of cost savings in sanitation practices. Responsible for actively participating in Change management (MOC) risk assessment related to Hygiene/ sanitation. Conduct regular trainings to shop floor team on cleaning and sanitation standards. Escalate Food safety risk indicators if any from time to time to the senior management and prevent food safety risks. Keep himself/herself abreast of latest hygiene/sanitation standards and implement best in class standards. Conducts staff training of site cleaning and sanitization procedures. Oversees & monitors housekeeping and cleaning programs. Performs daily audits of manufacturing and production to identify micro risk areas, clean design defects, and proper adherence and execution of C&S procedures. Oversees teardown and re-assembly process from a hygienic perspective. Participates in company continuous improvement initiatives by seeking out improved ways to clean and sanitize more efficiently & effectively. Coordinates with other operational units to maintain compliance and perform. Communicates with all sites in the region and globally to ensure consistency and sharing of best practices.

Division Integrated Product Development Department R&D Formulations Sub Department 1 Formulation ADL Job Purpose Execute the core method development activities and conduct analysis of routine as well as stability samples to finalize specifications and ensure timely delivery of product to unit. Key Accountabilities (1/6) Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Provide support to units or CFTs for transfer of analytical methods and techniques by visiting and demonstrating them with the relevant analysis to ensure successful and timely transfer of products Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations Key Accountabilities (2/6) Key Accountabilities (3/6) Key Accountabilities (4/6) Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Key Interactions (1/2) Key Interactions (2/2) Dimensions (1/2) Dimensions (2/2) Key Decisions (1/2) Key Decisions (2/2) Education Qualification M. Sc. (Analytical Chemistry) / M. Pharm Relevant Work Experience 2-4 years of experience in pharmaceutical organisation with knowledge of handling instruments like HPLC, GC, Dissolution tester and DPI related instruments Knowledge of current guidelines like ICH, EMEA, WHO

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 2. 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. 3. 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: M. Sc. Organic Chemistry Relevant Work Experience 3-5 yrs in process R&D

Grade / Level III Division / Department - R&D Job Purpose URGENT OPENING FOR THE ROLE OF GENERAL MANAGER - R&D Job Accountability: We are actively looking for credible team members who would be primarily responsible for: Encompassing literature survey. Identifying techno commercially attractive and non infringing route for fluoro-specialty molecules identified for commercialization in time bound manner. Develop & standardize industrially feasible processes and also meet long term cost targets. Identify & develop new products. Prepare feasibility report, cost analysis report, monthly progress report and TDR Demonstrate/validate the lab scale process up to commercial scale.. Essential Lead a team of scientist and chemists for new products / process development and improvement of the existing products. Knowledge and understanding of synthetic methods, analytical methods and relevant products. Excellent skills in interpretation of analytical data from UV, IR, NMR, GC, GCMS & HPLC, LCMS, MS and so on. Well versed with GLP, GMP and IMS guidelines. Understanding of literature/ patents. Understanding and accomplishment of Customer requirements. Knowledge of SAP & IMS. Educational Requirements: Ph.D. in Organic Chemistry Experience required : Minimum 15-18 years in R & D with at least 8 years as Group Leader/ Team Leader. Relevant and total experience Total Number of experience required - 18 Relevant experience required in - Fluorospecialities

QA Senior Executive / Quality Assurance Manager CTC UPTO 6 LPA, Contact: 09990842892 Email: info@wellgen.in We are a 30-year-old Medicine Manufacturer Company is located in Baddi Experience : Minimum 7 years of Pharmaceutical Experience Qualification : B.Pharm You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)Role & responsibilities Preferred candidate profile Male candidate

Study Pathologist for acute, sub-acute, sub chronic, reproductive, carcinogenicity, inhalation and dermal toxicity studies involving pharmaceuticals, biologics and agrochemicals. Study pathologist for animal model and efficacy studies. Providing technical contribution to the study plan. Involving and monitoring of animal euthanasia, gross examination, organ collection, verification, weighing and preservation. Online data entry using data capture software. Training of laboratory technicians for necropsy and histology techniques. Evaluation of blood cell morphology (RBC, WBC and platelet). Evaluation of bone marrow smear for M:E ratio, bone marrow differential count. Peer review of pathology data performed by other pathologists. Interpretation of clinical pathology, organ weight, gross and histopathology findings and preparation of pathology report. Providing periodic update to sponsor during pathology phase of the study. Ensuring proper documentation as per regulatory requirements. Ensure that work performed is in accordance with the requirements of the study plan and in full compliance with GLP. Involve in standardization and validation of new laboratory techniques. Ensure the compliance to EHS policy without deviation

PolyPeptide Group is seeking a highly experienced and dynamic Head of Generics to lead and drive the Generics business. The ideal candidate will have a strong background in B2B Pharma API sales, exceptional leadership skills, and a proven track record of achieving ambitious sales targets. This role requires extensive travel and collaboration with global teams to optimize and execute sales strategies, foster customer relationships, and position PolyPeptide Group as the preferred supplier in the market. Key Responsibilities: Sales Business Development: Develop, optimize, and execute the global sales strategy for the Generics business. Lead and drive the generic business through strong customer relationships and industry-leading customer service. Achieve personal and team sales targets for prospective and existing clients, aligning with PolyPeptide Group s overall business plan. Travel to relevant customers, seminars, conferences, and internal meetings. Understand market dynamics, competitor activity, and upcoming project opportunities to position PolyPeptide Group as the preferred supplier. Planning Reporting: Participate in relevant Sales Operations planning meetings. Prepare Generics Budget and long-term forecasts for business planning. Maintain an up-to-date repository on orders, forecasts, projects, and competitors in PolyPeptides CRM system. Other Responsibilities: Lead, mentor, and coach the global Generics team (sales and pipeline management). Collaborate with the leadership team at the Ambernath site on expansion and growth projects. Work with global functions to prepare and execute group objectives and strategies concerning Generics. Engage with Strategic Marketing and Business Intelligence to identify business opportunities and manage pipeline development. Negotiate and close contracts. Ensure timely collection of Accounts Receivables. Qualifications: Bachelors or master s in chemistry or a related field, with an MBA being a valuable addition. Minimum 12 years of experience in B2B Pharma API sales across different territories. Working experience working in an MNC / international organization ideally on a global scale, at least on regional level. Experience of working with Peptides would be an advantage. Well established network in the Generic industry covering big and medium sized generic companies globally. Strong strategic and tactical planning, and analytical skills. Excellent understanding of global markets, customer dynamics, and regulatory environment. Demonstrated ability to achieve sales targets and drive profitable growth. Ability and successful track record in building and maintaining relationships with key clients and stakeholders. Advanced problem-solving skills and ability to resolve customer complaints effectively. Experience in developing pricing strategies and sales campaigns. Exceptional contract negotiation and closing skills. Strong communication and presentation skills. Ability to analyze sales data and market trends to inform decision-making. Proven track record of successfully managing and leading high-performing commercial teams. Strong leadership and mentoring abilities. Flexibility to travel extensively for business purposes. Fluent in business English (oral and written) Why Join Us at Polypeptide Group: Polypeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of our team, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies. ",

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings). Coordinate with QA, RA, Production, and RD for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits. Experience 1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8 10 Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. C1. Principal thrust area: You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables Ensure manufacturing practices as per cGMP and GLP standards. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. Assisting HOD in customer complaint analysis and preparation of customer complaint report. Investigation of incidents, deviations, OOS and ensure corrective actions in place. Reviewing the daily availability of operators and allocating work to them. Maintaining and review BMR documents, guide for relevant changes if required. Label artwork review and management. D1. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). D2 . Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working . Reporting & Responsibility: Position Reports to: Plant Head (M03) Reportees to this position: Assistant Officer QA M12 (2 nos) Your Job Location: Tarapur MIDC. Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra. Preference will be given to candidates in Tarapur/Boisar area or willing to relocate. For outstation bachelors, Company provides a subsidized bachelors flat. For outstation families, Company provides subsidized accommodation in company owned buildings. Relocation allowance is offered. 3.Tarapur- Railway station Boisar takes 1.5 hrs. by train from Borivali Station or by road via Western Express Highway. Suburban local trains direct from Churchgate to Boisar Railway station available. What s in it for You: Opportunity to be part of a growing organization offering niche products to Pharma industry. Opportunity to work at Head Office location. Intimate small company culture with MNC professionalism. Company value programs TrANSSCEnD. Employee events like festival celebrations, family fun events etc Five days working (alternate weeks). Medical Insurance for your immediate family. Housing accommodation for Bachelors & family.

Thermo Fisher is seeking a new colleague who is passionate about customer experience, is technologically savvy, and has a passion for the digitization of science. The vision of Digital Science Solutions is to make it easy for scientific customers to digitize their research, development, and manufacturing lab operations. The Technical Consultant will be responsible for providing guidance, support, and implementation services related to Digital Sciences Solutions products such as LIMS, ELN, LES, SDMS, and other enterprise applications. You will work closely with clients to understand their laboratory processes and requirements, design solutions, perform system implementation tasks, and provide ongoing support and training to users. Your experience in configuration, data management, laboratory workflows, and regulatory compliance will contribute to the successful implementation and utilization of Digital Sciences solutions in various laboratory environments. Essential Duties and Responsibilities: Strategic: Trusted advisor to our customers, global account managers, services leaders, product managers, and delivery teams. Maintain and assume accountability for a culture of high customer service. Position Thermo Fisher Digital Science as a leader in life and laboratory science digitalization through successful delivery. Work with broader organization to achieve business objectives, expand multi-functional client engagements. Effectively share knowledge to help build a world-class digital solutions consulting and implementation team, working closely with global services leaders. Provide feedback to product management and engineering to rapidly advance our product capabilities to meet customer needs and expectations. Contribute to 3rd party technology, product, and solution evaluations in the context of our portfolio. Operational: Collaborate with clients, business analysts, project managers, and solution architects to understand their laboratory information management needs, workflows, and regulatory compliance requirements. Develop and document comprehensive solutions based on the gathered requirements, including system configuration, customizations, and integration with other laboratory systems. Participate in the implementation of enterprise laboratory solutions, ensuring that they are configured and customized correctly to meet client specifications and industry standard methodologies. Define data management strategies, including data mapping, migration, and validation, to ensure accurate and reliable data entry, storage, and retrieval within the solution. Assess laboratory workflows and find opportunities for process improvement and automation. Develop and execute test plans to ensure the system meets functional and performance requirements. Conduct user training sessions and provide ongoing support to laboratory staff, addressing questions, resolving issues, and ensuring effective system utilization. Prepare detailed user documentation, including system requirements, design specifications, user manuals, and standard operating procedures (SOPs). Work closely with multi-functional teams, including software developers, quality assurance analysts, and laboratory personnel, fostering effective collaboration and communication. Remain current with relevant industry regulations and guidelines (eg, FDA, ISO) and ensure that the implemented solutions align with these standards. Contribute to improving processes, ensuring compliance, and driving improvements. Provide recommendations into planning, resource allocation, management, tracking, and reporting on all aspects of customer engagements. Participate in team and customer meetings delivering engaging, informative presentations both to internal and external audiences. Travel, as needed, for internal and customer meetings. Culture: In line with the 4I values of Integrity, Intensity, Innovation, and Involvement, that form the foundation of the Thermo Fisher culture and ways of working, this role will bring intensity, innovation, and a high degree of involvement to designing, proposing, and delivering on Digital Science platform solutions. Business Partnership: Working collaboratively with Digital Science and broader Thermo Fisher colleagues to create and sustain a culture of delivering excellent customer experience, embracing continuous learning, leading with digital innovation, analytical thinking, and managing complexity. Knowledge, Skills, and Abilities Knowledge of enterprise laboratory software platforms, such as LIMS, ELN, LES, SDMS, CDS, or similar systems. Understanding of laboratory processes, data management principles, and laboratory workflows in various domains (eg, pharmaceutical, biotechnology, manufacturing). Familiarity with regulatory requirements and compliance standards relevant to laboratory operations (eg, FDA 21 CFR Part 11, ISO 17025, GLP, GMP). Experience with relational databases - Oracle, SQL Server, Postgres. Knowledge of cloud services and infrastructure highly desirable. Excellent problem-solving skills and ability to analyze complex business requirements and translate them into solutions. Demonstrated experience delivering in a matrix, global environment, across internal and external resources. Understanding of IT processes, SDLC methodologies, Quality Management Systems, and knowledge of regulatory landscape, with preference for experience in delivering and supporting validated systems. Superb communication and interpersonal skills, integrity, and credibility. Results focused, with attention to detail and a concern for quality. Planning, prioritizing, reporting, problem solving and analytical capabilities. Collaborative, initiates and facilitates communications and relevant information sharing, and works with different functions to achieve the best outcomes. Ability to exercise judgment and discretion concerning critical, confidential, and proprietary information. Flexibility in work schedule to accommodate communications with global team. Able to innovate and bring ideas forward and advance issues and risks in a positive way. Minimum Education and Experience Requirements bachelors or masters degree in IT, IS, Engineering, Life Sciences, or equivalent. At least 2-5 years of relevant experience in life sciences technical and business consulting with medium and large customers in the life and laboratory sciences industry, specifically, developing and deploying solutions catering to one or more areas of discovery, research, development, or manufacturing.

Thermo Fisher is seeking a new colleague who is passionate about customer experience, is technologically savvy, and has a passion for the digitization of science. The vision of Digital Science Solutions is to make it easy for scientific customers to digitize their research, development, and manufacturing lab operations. The Technical Consultant will be responsible for providing guidance, support, and implementation services related to Digital Sciences Solutions products such as LIMS, ELN, LES, SDMS, and other enterprise applications. You will work closely with clients to understand their laboratory processes and requirements, design solutions, perform system implementation tasks, and provide ongoing support and training to users. Your experience in configuration, data management, laboratory workflows, and regulatory compliance will contribute to the successful implementation and utilization of Digital Sciences solutions in various laboratory environments. Essential Duties and Responsibilities: Strategic: Trusted advisor to our customers, global account managers, services leaders, product managers, and delivery teams. Maintain and assume accountability for a culture of high customer service. Position Thermo Fisher Digital Science as a leader in life and laboratory science digitalization through successful delivery. Work with broader organization to achieve business objectives, expand multi-functional client engagements. Effectively share knowledge to help build a world-class digital solutions consulting and implementation team, working closely with global services leaders. Provide feedback to product management and engineering to rapidly advance our product capabilities to meet customer needs and expectations. Contribute to 3rd party technology, product, and solution evaluations in the context of our portfolio. Operational: Collaborate with clients, business analysts, project managers, and solution architects to understand their laboratory information management needs, workflows, and regulatory compliance requirements. Develop and document comprehensive solutions based on the gathered requirements, including system configuration, customizations, and integration with other laboratory systems. Participate in the implementation of enterprise laboratory solutions, ensuring that they are configured and customized correctly to meet client specifications and industry standard methodologies. Define data management strategies, including data mapping, migration, and validation, to ensure accurate and reliable data entry, storage, and retrieval within the solution. Assess laboratory workflows and find opportunities for process improvement and automation. Develop and execute test plans to ensure the system meets functional and performance requirements. Conduct user training sessions and provide ongoing support to laboratory staff, addressing questions, resolving issues, and ensuring effective system utilization. Prepare detailed user documentation, including system requirements, design specifications, user manuals, and standard operating procedures (SOPs). Work closely with multi-functional teams, including software developers, quality assurance analysts, and laboratory personnel, fostering effective collaboration and communication. Remain current with relevant industry regulations and guidelines (eg, FDA, ISO) and ensure that the implemented solutions align with these standards. Contribute to improving processes, ensuring compliance, and driving improvements. Provide recommendations into planning, resource allocation, management, tracking, and reporting on all aspects of customer engagements. Participate in team and customer meetings delivering engaging, informative presentations both to internal and external audiences. Travel, as needed, for internal and customer meetings. Culture: In line with the 4I values of Integrity, Intensity, Innovation, and Involvement, that form the foundation of the Thermo Fisher culture and ways of working, this role will bring intensity, innovation, and a high degree of involvement to designing, proposing, and delivering on Digital Science platform solutions. Business Partnership: Working collaboratively with Digital Science and broader Thermo Fisher colleagues to create and sustain a culture of delivering excellent customer experience, embracing continuous learning, leading with digital innovation, analytical thinking, and managing complexity. Knowledge, Skills, and Abilities Knowledge of enterprise laboratory software platforms, such as LIMS, ELN, LES, SDMS, CDS, or similar systems. Understanding of laboratory processes, data management principles, and laboratory workflows in various domains (eg, pharmaceutical, biotechnology, manufacturing). Familiarity with regulatory requirements and compliance standards relevant to laboratory operations (eg, FDA 21 CFR Part 11, ISO 17025, GLP, GMP). Experience with relational databases - Oracle, SQL Server, Postgres. Knowledge of cloud services and infrastructure highly desirable. Excellent problem-solving skills and ability to analyze complex business requirements and translate them into solutions. Demonstrated experience delivering in a matrix, global environment, across internal and external resources. Understanding of IT processes, SDLC methodologies, Quality Management Systems, and knowledge of regulatory landscape, with preference for experience in delivering and supporting validated systems. Superb communication and interpersonal skills, integrity, and credibility. Results focused, with attention to detail and a concern for quality. Planning, prioritizing, reporting, problem solving and analytical capabilities. Collaborative, initiates and facilitates communications and relevant information sharing, and works with different functions to achieve the best outcomes. Ability to exercise judgment and discretion concerning critical, confidential, and proprietary information. Flexibility in work schedule to accommodate communications with global team. Able to innovate and bring ideas forward and advance issues and risks in a positive way. Minimum Education and Experience Requirements Bachelor s or masters degree in IT, IS, Engineering, Life Sciences, or equivalent. At least 2-5 years of relevant experience in life sciences technical and business consulting with medium and large customers in the life and laboratory sciences industry, specifically, developing and deploying solutions catering to one or more areas of discovery, research, development, or manufacturing.

Job Title: Nonclinical SEND Data Associate Introduction to role Are you ready to harness the power of data for growth? At AstraZeneca, we are seeking data operatives to provide technical expertise for SEND data from nonclinical studies. This role is crucial in meeting health authority requirements and maximizing the opportunities these data present. Join us and lead the way for a new breed of solutions-oriented regulators! Accountabilities: As a Nonclinical SEND Data Associate, you will provide support across nonclinical functional areas, promoting and enforcing the use of nonclinical data standards. You will maintain metadata libraries, review and assess the impact of newly released and updated data standards, and communicate AZ data requirements to external vendors. You will also be responsible for quality validation and management of nonclinical datasets, training internal customers, assisting in warehousing and visualization activities, and ensuring submission-ready datasets are produced. Essential Skills/Experience: - Experience in a scientific environment - Knowledge of CDISC standards - Understanding of nonclinical study designs, data and documentation - Basic knowledge of regulatory guidelines and industry standards (FDA, ICH/GLP, PhUSE) - Experience in data process builds - Experience with LIMS and SEND solution software - Bachelor s degree (B.A./B.S.) or equivalent in a scientific or related discipline - Ability to communicate effectively (written and spoken) in English Desirable Skills/Experience: - Open to candidates with diverse skills and experiences

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and obtain approvals from CDSCO i.e., FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e., Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN, i.e., Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R&D, Quality Unit, Manufacturing, Supply Chain and Marketing team. Work closely with R&D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. Well versed about the online portals i.e., Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. He/She should be able to handle the queries raised by the aforesaid government department. Need to possess good communication.

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e. g. , DMF support, ANDA filings). Coordinate with QA, RA, Production, and RD for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc. ) and internal quality audits. Experience 1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Key Responsibilities Lead on-site Quality Control activities for agrochemical production at the plant. Ensure in-process and finished product quality meets regulatory and internal standards. Oversee sampling, testing, and analysis of raw materials, intermediates, and final products. Maintain calibration and performance of lab equipment (HPLC, GC, etc.). Prepare and manage documentation for audits, compliance, and certifications (ISO/GLP). Drive continuous improvements in plant QC practices and team efficiency. Qualifications 5-7 years of QC experience in a plant/factory setup within the agrochemical industry. Strong knowledge of analytical methods and safety protocols.

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 SOP s , 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 COA s 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. Bachelors degree

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 SOP s , 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 COA s 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. Bachelors degree

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 SOP s , 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 COA s 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. Bachelors degree

Career Category Information Systems Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE Role Description: This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps , use cases , and test plans for the software development teams. This enabl es the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Y ou will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre- clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. You will implement and manage scientific software platforms across the research informatics ecosystem , and provide technical support, training, and infrastructure management , and ensure it meets the needs of our Amgen R esearch community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework ( SAFe ) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. Basic Qualifications and Experience: Master s degree with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/Bioinformatics or related field , OR Bachelor s degree with 3 - 5 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/Bioinformatics or related field , OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/ Bioinformatics or related field , OR Preferred Qualifications: 3 + years of experience in implementing and supporting LIMS platforms . Functional Skills: Must-Have Skills : Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data E xperience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS platforms such as STARLIMS, Watson LIMS , LabVantage, etc. Good-to-Have Skills: Experience in the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation , and k nowledge of regulatory requirements affecting laboratory data (e. g. , FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud ( e. g. AWS) and on-premise infrastructure In-depth knowledge of Agile process es and principles for coordinated solutions and teams via SAFe Knowledge of business analysis best practices, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certification s: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation . .

? Job Description: ? ? We are seeking for a motivated and detail-oriented QC Trainee / Executive to join our quality team. The ideal candidate will be responsible for supporting quality control operations in method development, routine analysis, and documentation for APIs and intermediates under development. ? ? Key Responsibilities: ? ? Perform sampling and testing of raw materials, intermediates, and finished products. ? ? Conduct instrumental analysis (HPLC, UV, IR, GC) as per approved methods. ? ? Prepare and maintain Certificates of Analysis (COAs), logbooks, and test records ? ? Maintain lab notebooks, data integrity, and QC documentation ? ? Support in creating analytical method to identify, quantify and monitor impurities and the quality of the product ? ? Work closely with R&D and QA teams ensure compliance ? ? Requirements: ? ? 0 1 years of relevant experience in QC role. ? ? Familiarity with laboratory instruments and quality systems. ? ? Basic understanding of analytical techniques and GLP/GMP concepts ? ? Basic understanding of data integrity and GLP practices and Willingness to work in shifts (if required). ? ? Strong attention to detail and documentation skills. ? ? Willingness to learn, good observation skills, and attention to detail ?