211 Pq Jobs - Page 7

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 2...

> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years...

Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufact...

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, an...

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 Va...

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 ...

• 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, includi...

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.S...

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...

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 ...

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 ...

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, issue...

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 organi...

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 res...

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 an...

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 L...

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, help...

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...

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 qualific...

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 Do...

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 document...