21 Cfr Jobs

Key Role and Responsibilities: Should have experience in CSV (Computer System Validation) in Life Sciences domain. Should have good knowledge of GxP regulations and GAMP 5 Guidelines. Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations. Should have experience in defining the validation strategy, approach, and alignment with customer on QMS. Should have good knowledge of Good Documentation Practices. Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Should have experience of Validating Safety Systems. Should ha...

Role & responsibilities Must be aware of regulatory guideline like 21 CFR part 11, EUannex 11, GAMP 5 etc.. Must know about GAP assessment Must have exp in handling CSV of L1 , L2 system like DAS, DCS, Empower ,OSD /injectable Mfg equipment Must have knowledge for performing category 4 and 5 system Preparation and execution of validation deliverables like IRA,VP, URS,FS, CS, DS, FRA, IQ, OQ, TM, VSR Execution of qualification document without DI

You will play a crucial role in the finance department at Yara Fertilisers India Pvt Ltd, reporting directly to the Assistant General Manager - Accounts. Your responsibilities will include end-to-end management of capex budgeting, monitoring, and reporting in compliance with applicable rules and company SOP. You will need to have a deep understanding of costing principles, capex budgeting, and financial regulations such as CFR, IND AS, and FRS for global reporting. Your role will involve handling and reviewing product costing for both management and statutory reporting. You will be responsible for performing variance analysis of the cost of products compared to the previous year and estimate...

You will be playing a crucial role in the finance department at Yara Fertilisers India Pvt Ltd, reporting directly to the Assistant General Manager - Accounts. Your responsibilities will include end-to-end management of capex budgeting, monitoring, and reporting as per company SOPs and applicable rules. You will need to have a deep understanding of costing principles, capex budgeting, and financial regulations such as CFR, IND AS, and FRS for global reporting. It is essential that you have hands-on experience in financial reporting systems like SAP and Hyperion Financial Management (HFM) and possess cost accounting expertise. Your responsibilities will also include understanding and applying...

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test p...

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

Location: Ankleshwar Department: Quality Control Experience: 4 to 7 years Position : Executive Job Description: We are looking for a skilled HPLC Analyst (Executive QC) who will be responsible for ensuring quality compliance in laboratory testing of pharmaceutical raw materials, intermediates, finished goods, and stability samples. Key Responsibilities: Adhere to GLP (Good Laboratory Practices) and laboratory safety protocols . Perform routine and stability analysis of raw materials, intermediates, finished products, in-process samples , returned goods, hold time studies using HPLC . Maintain online documentation and ensure CFR 21 Part 11 compliance. Record and maintain analytical results in...

Responsibilities: * Manage import operations from start to finish * Ensure timely clearance through customs documentation * Prepare FOB/CFR documents accurately * Coordinate with suppliers & freight forwarders

Required Qualifications: Bachelors or master’s degree in mechanical, electrical, or Systems Engineering , or a related technical field. 3+ years of experience in V&V for medical devices , ideally with complex systems involving fluidics, embedded systems, or renal therapy technologies . Hands-on experience designing and executing verification tests for software-controlled electromechanical systems. Strong knowledge of systems engineering principles , including the V-model , requirement validation, and test traceability. Proficient in using lab instrumentation (e.g., flow meters, pressure sensors, data acquisition systems).

Medical R&D Team Lead-Chennai-10+years-NPD Job Category: TEAM LEAD Job Type: Full Time Job Location: chennai Years of Experience: 10+ years Position Overview This is an excellent opportunity to work for the global leading company in the field of gas control equipment. The focus of this role is managing our R&D team based in Chennai who are focused on Healthcare products and covering mechanical, electrical, electronics and software disciplines. Duties & Responsibilities Managing the teams actions to delivery New Product development projects. This is an end to end responsibility of successful project delivery from gate 0 to post project audit. Manage the R&D budget, timelines, and resources ef...

Job description BMS Validation Project - Execution SCADA Validation Project - Execution PLC System Validation Project - Execution To Handle the site engineers as per the project given by Head / Senior To prepare the work reports related to projects

Build CSR partnerships & donor relations Lead & execute fundraising campaigns Conduct due diligence on partners Align with internal teams for execution Ensure timely donor reports & updates Explore new funding channels Manage MoUs & legal compliance Required Candidate profile Graduate/PG with 4+ yrs in NGO/CSR fundraising, strong communication, project management, donor handling, MS Office skills, and ability to build partnerships and work independently.

Location: Mohali, near Chandigarh; WFH allowed Profile Summary: MSDS Authors are responsible for assessing product compositions or chemical formulations, researching hazards and properties of the components and from that determine appropriate hazard assessment according to country / region, for preparation of Material Safety Data Sheets. Current profile is for EU, North America including USA and Canada, and China regions. SDS Authoring Responsibilities: Independently assess product compositions or chemical formulations to applicable country regulations. Research hazards and properties of components to make appropriate MSDS classification for global regulations Determine appropriate Hazard As...

Experience: 7 to 14 years in Engineering for Automation and 21 CFR for Manufacturing Equipment Qualification: BE/B.Tech Designation- Senior Executive to Assistant Manager Level What is 21CFR Automation? 21 CFR Part 11 is an FDA regulation that defines the criteria under which electronic records and signatures are considered reliable and equivalent to paper. Roles involving 21CFR automation engineering typically lie at the intersection of automation, computer system validation (CSV), GMP compliance, and process control. Key Responsibilities: System Design & Integration Design , program , test , and implement automated systems (PLCs, SCADA) for manufacturing or laboratory use, ensuring they su...

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test p...

Responsible for Production planning ,finite scheduling with plant team to ensure the efficient delivery of inventory, service and cost objectives. Manage FG inventory, highlight risks of CFR cuts, come up with RCAs and ensure CFR of 98%+ Required Candidate profile Good exposure into continuous improvement initiatives improve processes, cost reduction ideas, supply chain cost optimization opportunities, or business process initiatives.

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...

GRC professional with good understanding of industry frameworks and standards 2. In-depth experience on Third-Party Risk Management a. Evaluating third party's cybersecurity control and ensuring they are in compliance with organizations standards and industry best practices b. Track and monitor the status of each due diligence review and communicate the status with management and key stakeholders on a regular basis c. Articulate risks and potential options for remediation or compensating controls d. Understand inherent risk assessment e. Perform new and recurring third party security risk assessments, develop mitigation plans, and work with internal stakeholders to assign remediation trackin...

Job Title: Junior IT Administrator Bioanalytical Lab Support Experience: 2-3 Years Job Summary: The Junior IT Administrator will assist in maintaining the IT infrastructure and systems used in regulated bioanalytical operations within a GLP/GxP-compliant CRO laboratory. This role involves daily user support, troubleshooting, and basic system administration related to lab instruments, LIMS, and networked IT systems. Key Responsibilities: User & System Support Provide first-level IT support for lab users on desktops, applications, and hardware. Troubleshoot issues with instrument PCs, printers, and lab software (e.g., LIMS, Lab Solution, Analyst software). Ensure timely resolution of support t...

Packaging Validation Engineer: Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and r...

Packaging Validation Engineer: Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and r...