92 Pq Jobs - Page 3

Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Role & responsibilities Job Responsibilities/Descriptions 1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA). 2.0 Participate in Equipment, Area, Utilities and Facility qualifications. 3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems. 4.0 To monitor the Performance Qualification of various equipment and systems at site. 5.0 Review of Performance Verification protocols and reports. 6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report. 7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area. 8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure. 9.0 Handling and knowledge on breakdowns, Notifications, and clearance request. 10.0 Basic knowledge on 21 CFT part 11 requirements. 11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level. 12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP. 13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems. 14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports. 15.0 Providing Quality oversight on engineering activities. Knowledge on Preventive maintenance and Calibration. Preferred candidate profile

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred

• Bachelors degree in Engineering, Science, or Technical Discipline • Strong communication skills, both oral and written • Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably) • PPAP and IQ, OQ & PQ

We are seeking a highly skilled and motivated Senior Analyst - Service Delivery Manager to oversee the services of our research applications and all associated service delivery activities in the Healthcare sector. In this role, you will foster a deep level of communication with the business teams to ensure effective solutions and high customer satisfaction. Have Outstanding verbal and written communication skills, along with the ability to understand service requests and incidents in healthcare, are key success factors. Manage end-to-end service delivery for resource applications, ensuring alignment with client expectations and business goals. Collaborate with cross-functional teams, including internal technical teams and external vendors, to facilitate smooth ticket execution. Develop and maintain strong relationships with clients, acting as the primary point of contact for service-related inquiries. Monitor ticket progress, identify risks, and implement mitigation strategies to ensure timely delivery, while also being willing to work on tickets for complex applications. Conduct regular reviews with clients to assess satisfaction and identify opportunities for improvement. Provide leadership and guidance to project teams, ensuring adherence to best practices and GxP and Non-GxP standards. Serve as a technical expert and technical lead for projects, providing insights and direction on technical matters. Display a sense of urgency in completion of key responsibilities. Who you are: Bachelors or masters degree in a relevant field. 5+ years of experience in Service delivery, project management, or related roles, preferably in the Health care, Life science or technology sectors. Strong understanding of GxP regulations and compliance in the healthcare or life science industry. Proven ability to manage complex requests and drive results in a fast-paced environment. Experience in Change and Release Management, along with incident and problem management. Proven experience in leading technical teams and projects supported with external consultants and be comfortable in working with both business- and technical teams. Experienced in service delivery framework and ensuring compliance to SLA and KPIs.

Walk-in Drive @ Bangalore on 22nd June 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles. Venue: Strides Pharma Science Ltd. (R&D office): 165/2, 3rd Main Road, Oppo. Kalyani Magnum Tech Park, JP Nagar 4th Phase, Bengaluru-560076 Open Positions Department: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Bangalore Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Bangalore Key Skills: Analysis of Raw Material, Finished products, In Process, Stability Samples, for Capsules & Tablets with expertise in HPLC. Department: Formulation Development Experience: 4-7 years Qualification: M.Pharm Job Location: Bangalore Key Skills: Planning & Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market. Department: Engineering Process Maintenance Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Sachet Filling line, Bottle Packing Machines. Department: Engineering Projects & Utility Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Installation, Commissioning, Equipment Qualification, DQ, IQ, OQ, PQ, Utility, Water System, HVAC, AHU, Chiller, Air Compressor, Cooling Tower, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time Software Testing Manager to join our Information Technology team in Mumbai. This position will manage a team of software testing engineers and software validation projects to implement effective and high quality software solutions. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across almost 40 countries. Responsibilities Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports; Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability; Maintain oversight of validation staff in managing change control of Medpace software applications; Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements; Ensure consistency of systems validation SOPs with best practices of industry; Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and Participate in Sponsor audits. Qualifications Bachelor's Degree; 7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry; Advanced knowledge of software development life cycle; Knowledge and understanding of the application of Risk Management concepts; Excellent analytical, written, and oral communication skills in English; Previous supervisory experience is preferred; and Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus! People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Role & responsibilities • You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents. • Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. • You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). • You will review and compile raw data, relevant certificates, analysis test reports and • preparation and review of final summary report. • You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation. • Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval. • You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification. • As part of your role, you will prepare and review VMP (Validation Master Plan). • You will conduct training for employees and external vendors as a qualified trainer. • Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label. • You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment. • You will also provide necessary assistance and support to various regulatory, internal and external inspections.

Responsibilities:- Perform preventative maintenance Installation Qualification IOP Perform Calibartion & validation Troubleshooting Identify and resolve issues with various equipment On Site Service Regular visiting different client locations Accidental insurance Annual bonus Performance bonus Mobile bill reimbursements Gratuity Provident fund Travel allowance Food allowance

Role & responsibilities Having experience in Pharma Plants certified by Regulatory bodies like USFDA, MHRA, EU-GMP, WHO-Geneva, etc. Candidate should have expertise in following : * Hands on experience in risk based qualification approach of pharma equipments (OSD / Sterile/ API) and clean utilities (HVAC system, WFI, PW, PSG, Compressed air, Nitrogen system etc. cleaning and process validation, * Conversant with RA, VMP, DQ, IQ, OQ, PQ document preparation and practical experience of protocol execution. * Quality Management System emeil id : hr@cgmppharmanplans.com Mobile +91 9650698486 Preferred candidate profile Perks and benefits

Computer System Validation Analyst Experience: 3-6 years Location: Hyderabad(On-Site) Roles and Responsibilities: Develop and execute Validation strategies in line with client needs and regulatory guidelines (GxP, 21 CFR Part 11, GAMP 5, EU Annex 11) Create and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, URS, RTM, and other required documents Conduct impact assessments, risk assessments, and manage change control processes Handle CAPA, incident management, and release management activities related to Validation activities Develop and maintain in-house SOPs related to Validation processes and ensure adherence to QMS Utilise JIRA for tracking tasks, issues, and project progress Collaborate with cross-functional teams to ensure successful Validation Documents preparation Stay up-to-date with industry best practices and regulatory changes related to Validation Qualifications: 3+ years of proven experience in serialisation implementation within the pharmaceutical industry Strong understanding of regulatory requirements (GxP, 21 CFR Part 11, GAMP 5, ICH Q9) Experience with validation protocols (IQ, OQ, PQ) and documentation (URS, RTM) Familiarity with quality management systems (QMS) and SOP development Proficiency in using JIRA or similar project management tools Excellent communication and interpersonal skills Preferred Skills: Experience with specific serialisation software and hardware solutions (mention specific platforms if applicable) Knowledge of supply chain management principles Certification in relevant areas (e g-, quality management, project management) Show more Show less

Capgemini Invent Capgemini Invent is the digital innovation, consulting and transformation brand of the Capgemini Group, a global business line that combines market leading expertise in strategy, technology, data science and creative design, to help CxOs envision and build whats next for their businesses. Your Role Use Design thinking and a consultative approach to conceive cutting edge technology solutions for business problems, mining core Insights as a service model Engage with project activities across the Information lifecycle. Understanding client requirements, develop data analytics strategy and solution that meets client requirements Apply knowledge and explain the benefits to organizations adopting strategies relating to NextGen/ New age Data Capabilities Be proficient in evaluating new technologies and identifying practical business cases to develop enhanced business value and increase operating efficiency Architect large scale AI/ML products/systems impacting large scale clients across industry Own end to end solutioning and delivery of data analytics/transformation programs Mentor and inspire a team of data scientists and engineers solving AI/ML problems through R&D while pushing the state-of-the-art solution Liaise with colleagues and business leaders across Domestic & Global Regions to deliver impactful analytics projects and drive innovation at scale Assist sales team in reviewing RFPs, Tender documents, and customer requirements Developing high-quality and impactful demonstrations, proof of concept pitches, solution documents, presentations, and other pre-sales assets Have in-depth business knowledge across a breath of functional areas across sectors such as CPRD/FS/MALS/Utilities/TMT Your Profile B.E. / B.Tech. + MBA (Systems / Data / Data Science/ Analytics / Finance) with a good academic background Minimum 10 years + on Job experience in data analytics with at least 7 years ofCPRD, FS, MALS, Utilities, TMT or other relevant domain experience required Specialization in data science, data engineering or advance analytics filed is strongly recommended Excellent understanding and hand-on experience of data-science and machine learning techniques & algorithms for supervised & unsupervised problems, NLP and computer vision Good, applied statistics skills, such as distributions, statistical inference & testing, etc. Excellent understanding and hand-on experience on building Deep-learning models for text & image analytics (such as ANNs, CNNs, LSTM, Transfer Learning, Encoder and decoder, etc). Proficient in coding in common data science language & tools such as R, Python, Go, SAS, Matlab etc. At least 7 years experience deploying digital and data science solutions on large scale project is required At least 7 years experience leading / managing a data Science team is required Exposure or knowledge in cloud (AWS/GCP/Azure) and big data technologies such as Hadoop, Hive What you will love about working here We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance. At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities. Equip yourself with valuable certifications in the latest technologies such as Generative AI. About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.

Job Description: We are looking for a skilled Data / Analytics Engineer with hands-on experience in vector databases and search optimization techniques . You will help build scalable, high-performance infrastructure to support AI-powered applications like semantic search , recommendation systems , and RAG pipelines . Key Responsibilities: Optimize vector search algorithms for performance and scalability. Build pipelines to process high-dimensional embeddings (e.g., BERT , CLIP , OpenAI ). Implement ANN indexing techniques like HNSW , IVF , PQ . Integrate vector search with data platforms and APIs . Collaborate with cross-functional teams (data scientists, engineers, product). Monitor and resolve latency , throughput , and scaling issues. Must-Have Skills: Python AWS Vector Databases (e.g., Elasticsearch , FAISS , Pinecone ) Vector Search / Similarity Search ANN Search Algorithms HNSW , IVF , PQ Snowflake / Databricks Embedding Models – BERT , CLIP , OpenAI Kafka / Flink for real-time data pipelines REST APIs , GraphQL , or gRPC for integration Good to Have: Knowledge of semantic caching and hybrid retrieval Experience with distributed systems and high-performance computing Familiarity with RAG (Retrieval-Augmented Generation) workflows Apply Now if You: Enjoy solving performance bottlenecks in AI infrastructure Love working with cutting-edge ML models and search technologies Thrive in collaborative , fast-paced environments

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 We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting 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 . Ability to learn quickly, be organized and detail oriented. 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.

Validation Lead Role Name Validation Lead Department Name Enterprise Engineering and Analytics (EEA) Role GCF 4 Job Family Software Development Engineer-Test I I Hiring Manager Name Asha Rani 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 We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s /Masters degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting 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 . Ability to learn quickly, be organized and detail oriented. 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.

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issues and addressing any business-critical escalations Research vendor information to determine appropriate contact for validation Conduct vendor outreach for vendor data validation Provide accurate, compliant and timely updates for validation outreach effort Manage outreach email box and respond/resolve issues in a timely manner Coordinate with Global team to ensure validations are performed in a timely manner Support Vendor Master escalation requests for master data maintenance related to blocking/unblocking vendor records and maintain overall master data integrity Understand the link between SAP, Ariba Cloud platform and the Ariba Network Support the monitoring and maintenance of vendor master data on a regular basis, to ensure data integrity and quality Provide regular reporting on Vendor Master data Continuously improve processes and procedures to enhance efficiency and effectiveness of the vendor master process. Supplier Enablement & Purchasing Catalogs Support connectivity of Suppliers to Amgen’s procurement systems Play a central role in managing supplier engagement for new catalog setup including preparing and testing new hosted catalogs and punch-out catalogs Support any ongoing monitoring and maintenance activities of catalogs, including monitoring catalog prices to ensure high accuracy of costs Communicate with local purchasing and technical teams and the supplier to resolve operational issues with catalogs. Provide related support to various stakeholders (e.g. answer questions, give requested support/advice, conduct trainings). Basic Qualifications Master’s degree OR Bachelor’s degree and 5 years of Finance experience OR Associate’s degree and 7 years of Finance experience OR High school diploma / GED and 10 years of Finance experience Preferred Qualifications 3+ years’ experience in Procure to Pay space, particularly working with master data and customer service SAP experience Ariba experience MS office proficiency especially Microsoft Outlook and Excel/CSV Ability to manage time to respond to incoming requests and prioritize appropriately to meet SLAs Motivated and responsive to changing priorities and deadlines Highly organized and reliable with strong attention to detail, verbal communication, and interpersonal skills Strong customer service focus while having a problem-solving attitude Ability to multi-task and work within tight timelines Work independently and take ownership of assigned activities Be a team player What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Role & responsibilities MAJOR ACCOUNTABILITY (Mention core tasks assigned to associate etc.) 1. Preparation of Qualification documents for Pharmaceutical HVAC system. - URS, DQ, IQ, OQ, PQ 2. Execution of HVAC modification projects 3. Review of HVAC assessment reports for modification scope of HVAC systems 4. Review of BOQ for HVAC modification 5. Preparation of URS for Air Handling Systems 6. Preparation of QRA & CR for HVAC modification projects 7. Review of HVAC layouts i.e. System zoning, Pressure Zoning, Area Classification drawings 8. Review of Heat Load calculations 9. Integration of new AHUs with BMS system & BMS system qualification 10. Creation of Maintenance plan, Calibration plan for the HVAC systems 11. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 12. Completion of all trainings assigned to role 13. Ensure integrity of data at workplace. 14. Ensure Good Documentation practices at workplace 15. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 16. Weekly meeting with cross functional team to meet project timeline. 17. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 18. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 19. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 20. Preparation of qualification document timely and Timely completion of project compliance action 21. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 22. Qualification documentation should prepare and execute with 100% accuracy without GXP error 23. All QMS actions should be completed within the assigned date. 24. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 25. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. Company : Sandoz Healthcare Location : Mumbai ( Kalwe ) Contract role and will be renewed yearly based share resumes to nedunuri.saikumar@manpower.co.in

We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality, compliant, and GxP validated. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen's standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get them reviewed and approved. Ensure validation strategies meet regulatory requirements and company standards. Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get them reviewed and approved. Stay updated on relevant changes to Amgen's SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and data engineering teams to drive validation activities and meet project deadlines. Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Basic Qualifications and Experience: Master's degree with 1 - 3 years of experience in Business, Engineering, IT, or a related field; OR Bachelor's degree with 2 - 5 years of experience in Business, Engineering, IT, or a related field; OR Diploma with 6 - 8 years of experience in Business, Engineering, IT, or a related field. Functional Skills: Must-Have Skills: 2+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.). Experience of working in software validation projects. Strong experience on tools like ALM, JIRA, etc. Must have worked in Agile or SAFe projects. Experience with automated and computer-controlled systems validation (21 CFR Part 11). Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Candidate must be able to write validation scripts in ALM and execute them independently. Experience with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Understanding of compliance and regulatory considerations in master data. In-depth knowledge of GDPR and HIPAA guidelines. Prior work experience in the MDM domain. Hands-on experience on JIRA, Confluence. Professional Certifications: CSV Certified. Agile or SAFe certified. Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams.

Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Documentation practices at workplace 13. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 14. Weekly meeting with cross functional team to meet project timeline. 15. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 16. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 17. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 18. Preparation of qualification document timely and Timely completion of project compliance action 19. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 20. Qualification documentation should prepare and execute with 100% accuracy without GXP error 21. All QMS actions should be completed within the assigned date. 22. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 23. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. company : Sando z Location : Mumbai (Kalwe Sight) share resumes to nedunuri.saikumar@manpower.co.in

The New Product Manufacturing Engineer (NPME) is responsible for ensuring smooth and compliant transition of new medical devices from design to manufacturing. This role plays a critical part in developing scalable, validated manufacturing processes, driving design for manufacturability (DFM), and executing Verification and Validation (V&V) activities in alignment with ISO 13485 and FDA 21 CFR Part 820. Key Responsibilities: Collaborate with R&D during the design phase to influence DFM and ensure manufacturability. Plan, execute, and document manufacturing Verification & Validation (V&V) activities, including equipment and process validations (IQ, OQ, PQ). Lead development of process documentation: PFMEA, control plans, work instructions, SOPs, and batch records. Develop manufacturing strategies, assembly procedures, and pilot line setups for new product introductions (NPIs). Drive tooling, fixture design, and automation planning for scalable and cost-effective production. Support and lead design transfer activities from engineering to manufacturing, ensuring production readiness. Participate in clinical builds and first article inspections (FAI), ensuring traceability and documentation compliance. Use statistical methods to analyse process capabilities and implement continuous improvements. Lead root cause investigations for manufacturing issues and support CAPA implementation. Collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Production teams to ensure product launch timelines are met. Provide input and support for regulatory submissions related to manufacturing process and V&V outcomes. Qualifications: Bachelors degree in mechanical, Manufacturing, or Industrial Engineering. 5+years of experience in medical device manufacturing, new product introduction (NPI), and process development. Strong knowledge of Verification & Validation (V&V) principles and experience with IQ/OQ/PQ protocols. Familiarity with ISO 13485, GMP, and FDA 21 CFR Part 820. Proficiency with CAD (e.g., SolidWorks), ERP systems (e.g., Odoo, SAP), and statistical tools (e.g., Minitab, JMP). Demonstrated ability to write and review technical documentation for audits and regulatory submissions. Preferred Skills: Experience in Class II/III medical device product launches. Exposure to cleanroom practices and ESD-safe assembly. Hands-on experience in FMEA, and process optimization.

Job Location: Ahmedabad Experience Year : 3+ Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define validation strategy based on risk and regulatory impact. Documentation: Create and review validation documentation including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. Document test results and deviations. Software Testing as per requirements Internal/ external release. Compliance: Ensure systems comply with applicable regulations (FDA, EMA, GAMP 5). Participate in audits and inspections. Maintain audit trail and data integrity practices. Risk Assessment: Perform risk assessments and impact analyses for changes to validated systems. Change Management: Evaluate system changes and determine need for revalidation. Support Change Control processes. Collaboration: Work with QA, IT, engineering, and business units to support the validation lifecycle. Train users and system owners on compliance requirements. System Lifecycle Support: Manage validation activities through system development, implementation, maintenance, and decommissioning.

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP FI S/4HANA Accounting Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Person must be having good experience on SAP FI. Must be having good experience on CR, Writing FS etc.As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that the applications align with business objectives and user needs, while maintaining a focus on quality and efficiency throughout the project lifecycle. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP FI S/4HANA Accounting.- Strong understanding of financial accounting principles and practices.- Experience with integration of SAP modules and third-party applications.- Ability to analyze business requirements and translate them into technical specifications.- Familiarity with SAP reporting tools and data analysis techniques. Additional Information:- The candidate should have minimum 7.5 years of experience in SAP FI S/4HANA Accounting.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done at time of IQ/OQ/PQ. Capable of making IQ/OQ and PQ protocols for Utility Systems. Coordinate between Project Manager & Utilities O&M for project work. Review pipelines & cables impacted by excavation work and align Utilities team. Should have experience in chiller operation and maintenance. Knowledge of other Utility areas like air compressors, vacuum pumps, RO system, water treatment plant. Provide troubleshooting of HVAC system, air compressor system and water treatment system. Conduct capability sessions through hands-on trainings and classroom sessions for PC&IS resources of Baddi & Bhiwadi. KPI deliverables Project Schedule deliverable As per the aligned timelines Leave planning – Needs to be aligned in advance and as per P&G standards with the manager. Final A on leave grant is the PM of P&G Quarterly performance reviews with PM Scope of contractor change in case not meeting aligned targets. Qualifications: Min Diploma in HVAC/Refrigeration/Mechanical/Piping system/Air Compressor System Experience: Min 5 years in HVAC operations, Air Compressor Systems and Water treatment Systems Have experience of project execution Basic electrical expertise Good communication skills – verbal & email Engagement duration Design work to Project SOP" Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pincode - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com

Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done at time of IQ/OQ/PQ. Capable of making IQ/OQ and PQ protocols for Utility Systems. Coordinate between Project Manager & Utilities O&M for project work. Review pipelines & cables impacted by excavation work and align Utilities team. Should have experience in chiller operation and maintenance. Knowledge of other Utility areas like air compressors, vacuum pumps, RO system, water treatment plant. Provide troubleshooting of HVAC system, air compressor system and water treatment system. Conduct capability sessions through hands-on trainings and classroom sessions for PC&IS resources of Baddi & Bhiwadi. KPI deliverables Project Schedule deliverable As per the aligned timelines Leave planning – Needs to be aligned in advance and as per P&G standards with the manager. Final A on leave grant is the PM of P&G Quarterly performance reviews with PM Scope of contractor change in case not meeting aligned targets. Qualifications: Min Diploma in HVAC/Refrigeration/Mechanical/Piping system/Air Compressor System Experience: Min 5 years in HVAC operations, Air Compressor Systems and Water treatment Systems Have experience of project execution Basic electrical expertise Good communication skills – verbal & email Engagement duration Design work to Project SOP" Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pincode - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com