67 21 Cfr Jobs - Page 3

Handling Following Type of Projects at Site as Leader: PLC System Validation Project - Execution Handle the site engineers as per the project given by Head. Co-ordinate between customers & Head/Senior. prepare the work reports related to project

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and doc...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality...

Mechanical Engineering - (Associate Manager/ Manager) Role & responsibilities Manage/support multiple projects that are ranging from new product development to life cycle management/ sustaining engineering. Defines design requirements and development specifications based on customer or user requirements. Contributes to development and documentation of mechanical system architectures. Contributes to ideations, troubleshooting and problem solving efforts related to new product development and sustaining projects. Hands-on experience in Design History File compilation / Technical file documentation. Good understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 ...

Validation Engineer I What you will do Let’s do this. Let’s change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to va...

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company ...

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of em...

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, su...

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...

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.

Bachelor's degree in a related field (e.g., Mechanical Engineering, Bio Medical) 8-10 years of work and project management experience, Leading or supporting the execution of Small to large-scale sustenance engineering projects like FCO (Field Change Orders) projects Strong Knowledge on ISO 13485, ISO 14971 and FDA- 21CFR 7, 21CFR 810 & 21CFR 806 Ensures to comply with QSR, ISO and Environment, HS requirements, as well as all applicable company procedures and policies Interacts and collaborates with other departments to solve any restriction that may stop or slow down process issues. Cross-Functional Collaboration: Facilitate cross-functional collaboration for remediation plan implementation,...

Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Polici...

Job Location: Ahmedabad Experience Year : 3-5 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 a 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),...

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requi...

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requi...