SAP Quality Assurance & Validation Consultant

Description :

Job Title : SAP QA & Validation Consultant (Team Hiring - 4 Positions)

Location : Remote

Workload : Full-time

Start Date : Immediate

Language Requirement : English

Project Overview :

We are looking to onboard a team of 4 skilled IT Quality Assurance (QA) & Software Validation professionals with strong experience in regulated environments.

The selected team will play a critical role in ensuring compliance, validation, and quality assurance of non-product software systems, including SAP and enterprise applications, in alignment with global regulatory standards.

This is an excellent opportunity to work on high-impact, compliance-driven projects within industries such as Medical Devices and In-Vitro Diagnostics (IVD).

Key Responsibilities :

1. Perform expert assessments of non-product software systems such as :

- HR applications

- ERP systems

- SAP environments

- Validated Excel-based tools

2. Execute end-to-end validation activities, including :

- Test case review and execution oversight

- Validation documentation review

- Ensuring completeness and audit readiness

3. Manage SAP-related changes from a QA & validation perspective :

- Impact analysis

- Risk evaluation

- Validation approvals

- Change documentation review

4. Conduct Quality Assurance checks aligned with regulatory standards :

- Ensure process compliance

- Verify documentation accuracy and traceability

5. Develop and maintain risk assessments :

- Evaluate regulatory impact

- Define appropriate validation and documentation levels

- Align with FDA expectations

6. Provide expert support in compliance-critical scenarios, including audits and inspections

7. Ensure adherence to industry standards such as :

- ISO 13485

- FDA regulations

- GxP guidelines

Required Skills & Experience :

1. Strong experience in software validation of non-product systems

2. Deep understanding of Quality Assurance processes and validation lifecycle (CSV)

3. Hands-on experience with :

- SAP change management

- Controlled / regulated environments

4. Familiarity with regulatory frameworks :

- FDA (21 CFR Part 11)

- Other global health authority guidelines

5. Strong knowledge of :

- ISO 13485 standards

- Documentation and compliance practices

6. Experience in :

- Medical Devices or In-Vitro Diagnostics (IVD) industry

7. Exposure to tools/environments such as :

- SAP Solution Manager

- DevOps-based validation frameworks

8. Excellent communication and stakeholder management skills

9. Strong command of English (written & verbal)

Additional Information :

- Team structure can include a mix of senior and junior professionals

- Opportunity to work in a highly regulated, global environment

- Immediate onboarding is highly preferred

- Fully remote engagement with international collaboration

Why Join This Project?

- Work on global compliance-driven initiatives

- Gain exposure to regulated industries (FDA, ISO standards)

- Collaborate with cross-functional international teams

- Enhance expertise in SAP QA & Validation frameworks