129 Regulatory Audits Jobs - Page 6

Role & responsibilities Operate and manage freeze drying and lyophilization equipment , including Freeze Dryer, Palltronic Integrity Tester, and CLU. Ensure smooth functioning of computerized systems such as eBMR, PLC, SCADA , and manage data integrity, audit trails, and system backups. Participate in equipment and area qualification/requalification activities, including LAF (Laminar Air Flow) systems. Ensure adherence to and documentation of Change Controls , Risk Assessments (RA) , Corrective and Preventive Actions (CAPA) , and EHS (Environment, Health, and Safety) protocols. Ensure compliance with regulatory standards and assist during audits and inspections . Maintain accurate and timely documentation as per GMP guidelines. Preferred candidate profile Bachelors degree in Pharmacy (B. Pharma) – Mandatory 4 to 7 years of experience in a sterile pharmaceutical manufacturing environment , specifically in Lyophilizer operations . Strong understanding of pharmaceutical regulatory standards , including GMP, FDA, MHRA, etc. Familiarity with automation and computerized systems like eBMR, SCADA, PLC. Sound knowledge of qualification protocols , equipment handling , and process controls . Excellent documentation and communication skills. Proactive, team-oriented mindset with the ability to handle audits and cross-functional coordination.

Job Purpose Responsible for ensuring the regulatory compliance of Technology Department Responsible for managing the regulatory audits and inspections of Technology Department Responsible for managing internal audit and process compliance verification of Technology Department Responsible for managing internal and regulatory communications Roles & Responsibilities Management of policies, procedures and governance framework for Technology Department Managing Creation / Modification / Review and management approvals of various policies and process documents of Tech Department Maintenance of Data and Reports related to Technology Compliance Managing Internal process audits of Tech Department Managing the internal Audit activity for System and Network Audit Tracking and ensuring various regulatory submissions and compliances Providing responses for various communications from SEBI and Internal Compliance Team Preparation of agenda notes for various committee meetings Coordinating with InfoSec team for any technical requirements for regulatory compliance of Cyber Security One point of contact for all the regulatory compliances, communication and audit activities. Management of Annual System and Network Audit Managing the auditor selection process along with the management approvals Managing the kick off meeting for commencement of System & Network Audit Managing the activities of System & Network Audit Collation of data for the audit from various departments Arranging Auditors Visit to Data Centres Drafting the initial responses for audit findings and managing the activity of providing management responses for the Draft Audit Report Review of the Final Audit Report Seeking Management Approval for the Final System Audit Report. Preparation of agenda notes for Management Approval Seeking internal certification from Management for the Management of Regulatory Inspections & Audits Assigning ownership for various data submissions of SEBI Inspection Collation of data for the Inspection from various process owners of Tech Department Providing responses to various queries of Inspection Team along with the necessary evidences Arranging walkthrough session for the inspection team, if required. Arranging visit to Data Centres of the Exchange Drafting the initial responses for regulatory inspection & audit findings and managing the activity of providing management responses for the Draft observations Presenting the inspection observations to Management for notation Educational Qualification Graduate / Postgraduate (Any Stream) Preferred CISA/CISM/ISO27001 Experience 12 to 15 years of Experience in the fieldof Internal / Regulatory Auditand Compliance for Exchange Skills Required Exhibit excellent analytical skills Functional Competencies required Executive-level written and verbal communication skills Interpersonal and collaborative skills Must be a critical thinker with strong problem-solving skills Behavioral Skills required Demonstrate ability to succeed withinfast-paced, high-growth environments. Poise and abilityto act calmlyand competently in high-pressure, high- stress situations. Ability to managemultiple projects understrict timelines as well as the ability to work well in a demanding, dynamic environment and meet overall objectives High level of personal integrity as well as the ability to professionally handle confidential matters and show an appropriate levelof judgment and maturity.

Hi, We are looking for an Infrastructure Audit professional. Below is the job description: What does a successful System Engineer / Audit Analyst do at Fiserv: Responsible for managing internal and external IT Infrastructure auditors. Work with internal IT SME to ensure audit specific controls are well implemented. Generate reports required to support clients regulatory compliance. What will you do: Coordinate all internal and external audit from Infrastructure perspective. Support the review of policies and procedures related to IT infrastructure security and regulatory compliance. Create and review Operation documents, internal/external presentations, SOPs, and other project documentation to support audit asks. Handling the customers, Internal and External regulatory audits. Ensure all audit finding get closed on speculated time. Prepare Audit report for monthly progress review and share it with senior management. Having knowledge of Service now and CMDB application. Develop and implement service strategies to meet internal team needs and improve service quality. Identify security and IT compliance gap, work with internal team for closure. What will you need to know: Should be an engineering graduate. Must have 4 to 5 years of experience in managing, supporting, facing audits. Have experience in handling IT Infrastructure Audits (internal and external). Sound knowledge of Network, Network Security, Operating Systems, storage and backup, IT standards and policies. What would be great to have: Experience in working with BFSI sector. We welcome and encourage diversity in our workforce. Fiserv is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protector veteran. Explore the possibilities of a career with Fiserv and Find your Forward with us !

KRA: Develop, implement, monitor QC procedures Inspect products at various stages of production Analyze data to identify areas for improvement Handle customer complaints, Customer/ ISO/ 3rd party audits Supplier quality management Root cause analysis Required Candidate profile Degree/ Diploma/ PG Diploma in mechanical 5+ years' experience in quality in technical textiles/ abrasives/ auto component industry Ready to travel or relocate to Murbad, Kalyan, MH