82 External Audits Jobs - Page 4

Implement and maintain the company’s QMS ISO 9001 Collaborate with cross-functional teams to ensure compliance with quality standardsDocumentation control and QMS records. Lead root cause analysis and resolution of quality issues and non conformances

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Oversee and manage essential Quality Management System documentation, including Design History Files (DHFs), CAPAs (Corrective and Preventive Actions), and change controls. Regulatory Compliance: Ensure strict adherence to FDA QSR (21 CFR Part 820), ISO 13485, EUMDR (EU Medical Device Regulation), and other relevant regulatory norms. Audit Support: Actively support internal and external audits (e.g., FDA, Notified Body), ensuring readiness and effective follow-up. Supplier Quality: Manage supplier qualification, monitoring, and quality agreements to ensure materials and services meet specifications. Training & Calibration: Coordinate and maintain training records and calibration programs to ensure compliance and operational effectiveness. Quality Improvement: Collaborate on product development initiatives and drive continuous quality improvements across the organization.

Have in-depth knowledge of governance, risk, and compliance, including internal auditing, audit standard, risk and compliance, cyber security review, policy review, ISO 27001, ISMS etc. Perform testing of IT Application Controls, IPE, and Interface Controls through code reviews, IT General Controls review covering areas such as Change Management, Access Management, Backup Management, Incident and Problem Management, SDLC, Data Migration, Batch Job scheduling/monitoring and Business Continuity and Disaster Recovery. Perform Risk Assessment, identification, and Evaluation of Controls, prepare process flow diagrams and document the same in Risk & Control Matrix. Perform business process walkthrough and controls testing for IT Audits. Performing planning and executing audits, including - SOX, Internal Audits, External Audits Conducting controls assessment in manual/ automated environment Prepare/Review of Policies, Procedures, SOPs Maintain relationships with client management and the project Manager to manage expectations of service, including work products, timing, and deliverables. Demonstrate a thorough understanding of complex information systems and apply it to client situations. Use extensive knowledge of the client's business/industry to identify technological developments and evaluate impacts on the work to be performed. Coordinate effectively and efficiently with the Engagement manager and the client management keeping both constantly updated regarding projects progress. Collaborate with other members of the engagement team to plan the engagement and develop relevant workpapers/deliverables. Perform fieldwork and share the daily progress of fieldwork, informing supervisors of engagement status

Key Responsibilities: Conduct routine product and process inspections to ensure compliance with quality standards. Monitor production processes and identify deviations or defects. Document inspection results and maintain accurate quality records. Collaborate with production and QA teams to implement corrective actions. Ensure compliance with industry standards, safety regulations, and company policies. Participate in internal audits and assist with external audits. Maintain and calibrate testing equipment. Provide training to staff on quality procedures when necessary.

Role: Process Specialist Exp: Min 2+ years into 401K-US Retirement Salary: Max 6.5 LPA Must have experience: Defined Contribution/Defined Benefit Location: Bangalore Immediate joiner to 30 Days

Lead Country F&A focusing on FINANCIAL STATEMENTS, COMPLIANCE, ACCOUNTING STANDARDS, CASH FLOW, LIQUIDITY, STRATEGIC INVESTMENTS, FINANCIAL REGULATIONS, EXTERNAL AUDITS, COST SAVING INITIATIVES, FINACIAL PLANNING, BUDGETING, TAXATION, F&A STRATEGY et Required Candidate profile CA Qualified Only 10+yrs exp into into F&A with Manufacturing Unit handling core F&A - Financial Statements, Cash Flow, Compliance, Audit, F&A Planning Strong skills in Analytics, IGAAP, USGAAP, ERP Perks and benefits Excellent Perks. Please mail cv.ch2@adonisstaff.in

Role & responsibilities System Management: • Establish, implement, and maintain IMS processes in line with ISO and legal requirements. • Ensure continued certification and compliance with ISO 9001, ISO 14001, ISO 45001 and ISO 50001 standards. • Ensure the QC and 5S SOPs are followed across all the plants. Documentation & Compliance: • Maintain and update IMS documentation including policies, procedures, and manuals etc. • Facilitate employee access to IMS documents and manage security levels for access. • Ensure 100% fulfillment of Legal requirement in plant. • Prepare monthly plant MIS reports for the management. Audit & Reporting: • Prepare the internal audit plan and ensure the internal audits are completed timely. • Ensure all the NCs and OFIs identified are closed with proper corrective actions. • Coordinate and support the external ISO audits program and ensure the audits are conducted smoothy. Training & Support: • Provide training and guidance to employees on IMS, QC,5S, Kaizen initiatives. • Act as a point of contact for IMS-related queries and support. Collaboration: • Work with various departments to ensure IMS integration across operations. Continuous Improvement and Performance Optimization: • Monitor QC, Kaizen & 5S progress of all functions and publish the report monthly. • Analyze performance data to identify areas for improvement and implement strategies to enhance system effectiveness, drive continuous improvement initiatives to ensure QC, Kaizen & 5S support organizational goals and deliver optimal value.