Internal Quality Auditor
3 days ago
Internal Quality Auditor.
Job Summary:
We are seeking an experienced Internal Auditor to join our team. The ideal candidate should have a strong background in internal auditing / Global Auditing / Corporate Auditing within the Biopharmaceutical industry (specifically SME in any of the GxP processes like Manufacturing, Testing (Analytical and Microbiology), Data Governance so on).
Key Responsibilities:
Audit Planning and Execution:
- Develop and execute comprehensive audit plans to assess the effectiveness of internal controls, risk management, and governance processes.
- Conduct audits of operational and compliance processes within the organization.
- Assess risk to identify areas of potential vulnerability and recommend corrective actions.
- Preparation of audit reports, communication of observation to auditees.
- Initiation of CAPAs and tracking for closure.
- Support site’s during audit.
Compliance and Regulatory Audits:
- Ensure adherence to relevant industry regulations, including FDA, EMA, and other regulatory requirements.
- Review and evaluate the company's compliance with internal policies, procedures, and external regulatory standards.
- Conduct audits related to Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP) and other relevant guidelines.
Data Analysis and Reporting:
- Analyze audit findings and prepare detailed reports with actionable recommendations, as applicable.
- Present audit findings to senior management and the audit committee.
- Monitor and track the implementation of audit recommendations and corrective actions.
Internal Control and Risk Management:
- Evaluate the design and effectiveness of internal controls and identify areas for improvement.
- Assess the adequacy of risk management processes and recommend enhancements.
- Collaborate with management to develop and implement effective internal control systems.
Continuous Improvement:
- Stay updated on industry trends, regulatory changes, and best practices in internal auditing.
- Provide training and support to other team members on audit methodologies and compliance requirements.
- Promote a culture of continuous improvement and operational excellence within the organization.
Global Quality Operations:
- Support the implementation of harmonized global policies and procedures conforming to applicable GxP regulations.
- Align standard and operating procedures harmonization efforts with identifying redundancies, streamlining processes, continuous improvement, efficiency improvement, effective management, regulatory requirements, and implementing best practices.
- Management of Risk Assessment, Audit related QMS and other scope of work.
Qualifications and other requirements:
- Master’s degree / bachelor’s degree in pharmacy, Science, Biotechnology.
- Professional certification as Auditor (ISO, ASQ and others).
- Minimum of 15 years of experience within the Biopharmaceutical industry specifically Drug Substance, Drug Product and combination product manufacturing.
- Strong knowledge of industry regulations, including FDA, EMA, ISO requirements.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication and interpersonal skills with the ability to interact effectively with all levels of the organization.
- Ability to travel as needed.
- Should have handled team of at least 5 members.
-
Internal Quality Auditor
4 days ago
Bangalore Urban, India Biocon Biologics Full timeInternal Quality Auditor.Job Summary:We are seeking an experienced Internal Auditor to join our team. The ideal candidate should have a strong background in internal auditing / Global Auditing / Corporate Auditing within the Biopharmaceutical industry [specifically SME in any of the GxP processes like Manufacturing, Testing (Analytical and Microbiology),...
-
IT Auditor
2 days ago
bangalore, India Siemens Healthcare Private Limited Full timeResponsibilities: We are looking for 6 to 10 years of experience in Quality and Auditing Evaluate Siemens Healthineers IT Quality Management System (QMS), for compliance with, as applicable: ISO 9001, and ISO 27001 as well as applicable standards and guidance documents specific to the audit target. Knowledge of ISO 13485 and MDSAP would be an advantage. Act...
-
Quality Assurance Auditor
5 days ago
bangalore, India PSI CRO Full timeJob DescriptionWe are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones. You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work...
-
Internal Auditor
3 days ago
bangalore, India East Point College of Medical Science & Research Centre Full timeMAJOR RESPONSIBILITIES A. Review and Evaluate Operating Areas of East Point Group of Institutions and Related Enterprise Partners 1. Perform operational and financial audit assignments and other audit services identified by the Head of Internal Audit. 2. Identify areas/activities requiring audit review through observations made during the course of...
-
bangalore, India Seven Consultancy Full timeJOB DETAILS 1. The internal auditor is responsible for providing an objective and independent appraisal of all the companies’ activities2. The internal auditor is responsible for giving accurate information to the companycorporate management team on the risk management, control and value of quality matters3. Establish and monitor the achievement...
-
bangalore, India Seven Consultancy Full timeJOB DETAILS 1. The internal auditor is responsible for providing an objective and independent appraisal of all the companies’ activities2. The internal auditor is responsible for giving accurate information to the companycorporate management team on the risk management, control and value of quality matters3. Establish and monitor the achievement...
-
Internal Auditor
4 weeks ago
bangalore, India Sustainability Economics Full timePosition Title: Cost Accountant/Internal Auditor– Power SectorLocation:Bengaluru, KarnatakaAbout the Company:Sustainability Economics is a global organisation targeting the markets of US, Japan, EU, UK, Canada and Singapore. As a pioneer, our focus is on the Lifecycle Management of E2E Net-Zero transitions while leveraging our automation-first approach....
-
Internal Auditor
3 weeks ago
bangalore, India Sustainability Economics Full timePosition Title: Cost Accountant/Internal Auditor– Power SectorLocation:Bengaluru, KarnatakaAbout the Company:Sustainability Economics is a global organisation targeting the markets of US, Japan, EU, UK, Canada and Singapore. As a pioneer, our focus is on the Lifecycle Management of E2E Net-Zero transitions while leveraging our automation-first approach....
-
Internal Auditor
6 days ago
bangalore, India Sustainability Economics Full timePosition Title: Cost Accountant/Internal Auditor– Power SectorLocation:Bengaluru, KarnatakaAbout the Company:Sustainability Economics is a global organisation targeting the markets of US, Japan, EU, UK, Canada and Singapore. As a pioneer, our focus is on the Lifecycle Management of E2E Net-Zero transitions while leveraging our automation-first approach....
-
Senior IT Security Auditor
2 months ago
bangalore, India Siemens Healthcare Private Limited Full timeWe are looking for a Lead Auditor with 8 to 10 years of experience in ISO 27001, IT Security and Auditing. Responsibilities are to include, but not limited to: •Acting as a Lead Auditor alongside qualified Audit Teams. •Developing, designing, and executing IT Security Audits and Assessments ad-hoc and as per the global internal Audit Plan.•Auditing...
-
Senior IT Security Auditor
3 weeks ago
bangalore, India Siemens Healthcare Private Limited Full timeWe are looking for a Lead Auditor with 8 to 10 years of experience in ISO 27001, IT Security and Auditing. Responsibilities are to include, but not limited to: •Acting as a Lead Auditor alongside qualified Audit Teams. •Developing, designing, and executing IT Security Audits and Assessments ad-hoc and as per the global internal Audit Plan.•Auditing...
-
Internal Auditor
6 days ago
bangalore, India Sustainability Economics Full timePosition Title: Cost Accountant/Internal Auditor– Power Sector Location: Bengaluru, Karnataka About the Company: Sustainability Economics is a global organisation targeting the markets of US, Japan, EU, UK, Canada and Singapore. As a pioneer, our focus is on the Lifecycle Management of E2E Net-Zero transitions while leveraging our automation-first...
-
Internal Auditor
4 weeks ago
bangalore, India Bosch Full timeJob Description IT Auditor with special focus on Cloud and Cloud Security. We are seeking a highly skilled and experienced cloud architect or cloud security professional to join our Internal IT auditing team. As an IT auditor, you will assess maturity of the cloud applications and platform, identify potential risks, and provide actionable...
-
Internal Auditor
2 weeks ago
bangalore, India Bosch Full timeJob Description IT Auditor with special focus on Cloud and Cloud Security. We are seeking a highly skilled and experienced cloud architect or cloud security professional to join our Internal IT auditing team. As an IT auditor, you will assess maturity of the cloud applications and platform, identify potential risks, and provide actionable...
-
bangalore, India Seven Consultancy Full timeJOB DETAILS 1. Preparation in the development of Risk Based Audit Plan2. Preparation of audit scope and work program.3. Supporting team in Field work.4. Review the work of team members5. Preparation of audit report6. Discussion of report with the concerned functional head7. Finalization of report & submission to the senior management8. Preparation...
-
bangalore, India Seven Consultancy Full timeJOB DETAILS 1. Preparation in the development of Risk Based Audit Plan2. Preparation of audit scope and work program.3. Supporting team in Field work.4. Review the work of team members5. Preparation of audit report6. Discussion of report with the concerned functional head7. Finalization of report & submission to the senior management8. Preparation...
-
Senior Analyst
4 weeks ago
bangalore, India Dotdash Meredith Full timeJob Description Primary responsibilities 1.Perform audit work, including plan preparation, work papers, findings, and associated reports.2.Prepare audit reports and work papers to ensure adequate documentation exists to support the completed audit andconclusions.3.Assess, design, document and test the operating effectiveness of key controls.4.Conducting...
-
Senior Analyst
3 days ago
bangalore, India Dotdash Meredith Full timeJob Description Primary responsibilities 1.Perform audit work, including plan preparation, work papers, findings, and associated reports.2.Prepare audit reports and work papers to ensure adequate documentation exists to support the completed audit andconclusions.3.Assess, design, document and test the operating effectiveness of key controls.4.Conducting...
-
bangalore, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Management/coordination/oversight of QA compliance GxP activitiesin a specific geographical and/or functional/specialist area : Lead and work independently and as part of the QA team Act as expert GxP consultant in relevant area to groups within the Parexel organization and...
-
Internal Auditor
4 weeks ago
bangalore, India CA Monk Full timeKeyResponsibilities: Leadand assist in the planning execution and reporting of InternalAudit & Risk consulting engagements covering IA IFC SOXSOP/Process andControls.Manageclient interactions and relationships at the Finance team / Processowner levels ensuring clear communication and effective resolutionofissues.Reviewthe work performed by the audit team...
