15 Cfr Jobs

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 CFR, IND AS, and FRS standards for global and local financial reporting, handling and reviewing product costing for management and statutory reporting, performing variance analysis of cost of products, monthly inventory valuation and product costing, preparing and analyzing annual data for statutory submissions, data preparation for audits, and utilizing SAP and HFM for financial reporting tasks. The ideal candidate should have strong analytical capabilities, be self-driven, detail-oriented, and have excellent collaboration and stakeholder management skills. You should be proficient in MS Excel for data analysis, SAP, and Hyperion reporting tools. Knowledge of Power BI would be an added advantage. To be eligible for this role, you must hold an ICWA/CA degree and have scored 60% in 10th, 12th, and Graduation. The preferred candidate should have 2 to 8 years of relevant experience, with at least 1-2 years of experience in a plant setup. Candidates with prior experience in reputed companies will be given preference. Yara is an equal opportunity employer committed to creating a diverse and inclusive environment. As part of the recruitment process, reference and background checks may be conducted when deemed necessary for the job nature. You will be informed by HR before any background checks are initiated. If you possess the required qualifications, experience, and skills, we encourage you to apply for this position by August 12, 2025. For further information, please contact Muskan Jain from Human Resources.,

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 protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Qualifications we seek in you! Minimum Qualifications / Skills BE/B Tech Preferred Qualifications/ Skills Familiar with writing tests for Web-based software architectures Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent). Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus. Critical thinker and problem-solving skills Team player Good level in English Great interpersonal and communication skills Looking for Immediate to 45 days joiners.

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, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

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 worksheets and LIMS modules. Conduct analysis as per current STP, SOPs, and specifications . Prepare and standardize reagents, solutions, and mobile phases as per requirement. Ensure column performance is tracked and updated in column logbooks . Maintain instrument logbooks , calibration schedules, and instrument history records . Participate in analytical method transfer (AMT) with A.R. laboratory teams. Prepare stability protocols and reports , and perform stability sample analysis . Monitor temperature & humidity of laboratory, refrigerators, and working standard chambers. Report and initiate investigations for OOS, OOT, Deviation, QI, NQI, and discrepancies in analysis. Follow Good Chromatographic Practices for integration and review of chromatographic data. Ensure data integrity and compliance during all analytical activities. Communicate and coordinate with stores for urgent material analysis. Avoid solvent/chemical wastage and ensure clean laboratory operations. Interested candidate please fill the below given link: https://docs.google.com/forms/d/e/1FAIpQLScDxs_rRkTFo3l4kQNsy9oij5XXDEi4ztPPsIbwxHvGaLaKbA/viewform?usp=header

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 effectively to achieve project goals on time and within scope Collaborate with business managers, product managers, regulatory, production, purchasing to ensure that new products and technologies meet healthcare standards, regulatory requirements, and market needs. Contribute to align the R&D strategy with the business growth goals Creative input to the NPI projects and program Point of contact for technical questions from customers/production/product management/quality & regulatory Creation, completion, and management of technical files for relevant product lines Determining test criteria, organising testing and interpretation of results Working closely with procurement to drive cost savings Working closely with production to deliver optimized production processes Metrics of success for the role Delivery of the product roadmap Project performance KPIs including, time to market, development cost, product cost, sales impact and product performance criteria Delivery of cost reduction projects Delivery on quality improvement projects Required Qualifications: Masters in Engineering Mechanical or Electronics as a minimum Minimum of 10 years of experience in R&D leadership in the healthcare or medical device industry or highly regulated industry. 3-5 years experience working in a multinational, preferably American led organization working in a Global function preferably R&D. Experience leading Engineering process (Stagegate) and systems (PLM). Preference to those with a strong understanding of healthcare regulations (FDA, CE), quality standards (ISO), and product standards (NFPA, HTM, ISO, CFR, CGA, CRN

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 Assessments and MSDS phrases based on assessment Acts as Project POC for clients. Lead the client projects to completion. One hundred percent client facing job. Deliver overseas client authoring requirement. Actively work with team other members to incorporate improvement projects. Mentor junior authors in Platform utilization and other system/tools. Create and format MSDS documents utilizing client suggested MSDS authoring platform Review of completed MSDSs 5-day job (Mon to Fri); 9.5 hours per day. Daytime job, may involve late evening work and communications with overseas clients WFH allowed for right skills candidates; should possess strong internet connection and a laptop/CPU for working from home and should be familiar with communication tools such as MS TEAMS Qualifications : Bachelors degree in Chemistry from reputed university 5 10 years prior MSDS authoring experience with reputed service providers or MNC chemicals manufacturing companies Excellent analytical and communications skills with very good command over English (spoken and written) Good knowledge of MS Office Well versed in regulations (i.e., CLP, OSHA, WHMIS, GHS, 49 CFR, 29 CFR, HazCom, ROHS, Inventories, TDG etc.) Knowledge of prevalent MSDS authoring s/w platforms - SAP EH&S and/or MSDgen , WERCS or other similar s/w; Knowledge of extended SDS for ECHA is a plus Staff capable of authoring all 16 sections of SDS is preferred Knowledge of chemical compounds, families, and pharmaceutical products. Knowledge of active versus inactive ingredients in respect to physical form, volume, hazards.

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 support FDA-regulated processes Validation & Compliance Develop and execute validation documentation including URS, FS, DSand protocols such as IQ, OQ, and PQ, all aligned with 21CFR Part 11, cGMP, and GAMP standards Ensure compliance with data integrity, user security, disaster recovery , and system backup provisions per Part 11 Support & Troubleshooting Provide day-to-day operational support , including on-call troubleshooting for upstream/downstream manufacturing systems Lead rootcause analyses for system failures and corrective/preventive action (CAPA) activities Documentation & Audit Readiness Document processes, software versions, maintenance logs, and validation reports to maintain audit trails Support audits ; act as subject-matter expert for internal and regulatory inspections Cross-Functional Leadership Collaborate with process engineers, QA, IT, production , and external vendors to align automation with operational and compliance requirements . Drive continuous improvement through smart manufacturing Cybersecurity & Regulatory Controls Maintain enterprise-level cyber resiliency , including OS patching, control system security, and user access compliance Key Skills and Competencies: Hands-on experience with 21 CFR and Automation in Engineering for OSD/Injectable Facility area equipment. Good knowledge of cGMP Hands on Technical exposure on PLCs,SCADA,HMI System specs, trace matrices, IQ/OQ/PQ, CSV per 21CFR Part 11 and cGMP Deep knowledge of FDA regulations (Part 11, data integrity, cyber security compliance) Troubleshooting, CAPA, on-site support, SOP development Role & responsibilities Preferred candidate profile

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 protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Qualifications we seek in you! Minimum Qualifications / Skills BE/B Tech Preferred Qualifications/ Skills Familiar with writing tests for Web-based software architectures Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent). Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus. Critical thinker and problem-solving skills Team player Good level in English Great interpersonal and communication skills Looking for Immediate to 45 days joiners.

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 documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

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 tracking responsibility 3. Strong business and communication skills 4. Experience in driving meetings with stakeholders 5. Provide advisory and consulting to client on new trends and challenges in enterprise risk management area 6. Experience in design and development of information security policies, standards, and guidelines 7. Experience on SIG (shared assessments), ISO 27001, NIST framework, SOC 1, SOC2, ISO 27001 and HIPAA 8. Lead and drive meeting with top management 9. Design / modify Contract security language / security clauses 10. Co-ordinate and negotiate security clauses with Procurement team and Supplier 11. Experience on GRC platforms 12. Client interface for understanding the IT Governance, IT Risk & Compliance Management Controls as applicable to Infrastructure operations 13. Well versed and hands-on experience for establishing processes, controls and audits of compliances like HIPAA, CFR, PCI DSS & SOX ITGCs. 14. Documentation of as-is IT & Risk management Controls as they are currently being executed in client environment and ensuring that the same controls are followed and implemented in service delivery operations 15. Work with the client & technical teams for change request on any risk or control implementation as well as governance process 16. Participate in internal as well as external regulatory as well as IT security audits. Understand IT Risks and define audit & governance mechanisms for assets, processes & physical security