IT Quality & Compliance Specialist
QAAgility Technologies
- Location
- Bengaluru, Karnataka, India
- Job type
- Full-time
Required skills
- change management
- compliance
- Root Cause Analysis
- SAP
About the role
QAAgility Technologies
Website:
qaagility.com
Job details:
Job Description
- We are seeking an experienced SAP IT Quality & Compliance Specialist with a strong background in IT Quality and Compliance (ITQC) within the SAP landscape.
- The role focuses on supporting GxP-regulated SAP systems by ensuring compliance across system releases, change management, risk management, and deviation management.
- The candidate will work closely with the System Manager and Change Manager to support day-to-day compliance activities.
Mandatory Skills (Must Have)
- Strong IT Quality & Compliance (ITQC) background in the SAP environment.
- In-depth knowledge of GxP regulations and compliance requirements.
- Proven experience in Deviation Management, including:
- Creation of deviations.
- Root cause analysis.
- Definition and tracking of mitigation and corrective actions.
- Experience in Risk Management, including:
- Review of system risks.
- Identification and documentation of mitigation actions.
- Experience in Release Management, including:
- Review of change requests.
- Ensuring changes meet GxP and compliance requirements.
Optional Skills (Good To Have)
- Hands-on experience with ITQC activities for SAP S/4HANA.
- Familiarity with SAP validation frameworks and documentation standards.
- Experience working in regulated industries such as pharmaceuticals, biotech, or medical devices.
Roles & Responsibilities
- Support the System Manager and Change Manager in day-to-day compliance-related activities.
- Handle all GxP compliance tasks for SAP systems across major and minor releases.
- Perform and support Deviation Management activities, including documentation, investigation, and closure.
- Review and assess system risks and ensure appropriate mitigation actions are defined and implemented.
- Review change requests to ensure compliance with regulatory and quality requirements.
- Ensure adherence to ITQC processes, policies, and procedures.
- Support audits and inspections by providing required compliance documentation and :
- Bachelors degree in Information Technology, Computer Science, Engineering, or a related field.
- 5+ years of experience in SAP IT Quality & Compliance or a similar GxP-regulated IT role.
- Experience working in GxP-regulated environments (e.g., Pharma, Life Sciences).
- Strong documentation, communication, and stakeholder management skills.
(ref:hirist.tech)
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