IQVIA SmartSolve Techno-Functional Consultant - Quality Management Systems

Description :

Job Summary :

We are seeking an experienced IQVIA SmartSolve Techno-Functional Consultant-with strong expertise in Quality Management Systems (QMS). The role involves configuring, implementing, supporting, and optimizing IQVIA SmartSolve solutions while ensuring compliance with global regulatory standards. The consultant will act as a bridge between business stakeholders and technical teams across global engagements.

Key Responsibilities :

Functional Responsibilities :

- Lead and support IQVIA SmartSolve QMS-implementations and enhancements

- Gather, analyze, and document business requirements for QMS processes

Configure SmartSolve modules such as :

- Document Management (DMS)

- Training Management

- CAPA

- Change Control

- Deviations

- Audits & Inspections

- Ensure compliance with GxP, FDA 21 CFR Part 11, ISO 13485, ISO 9001-and other global regulations

- Conduct user training, workshops, and UAT support

- Prepare functional specifications, validation documents, and SOPs

Technical Responsibilities :

- Perform SmartSolve configuration and basic customization

- Support integrations with other enterprise systems (e.g., ERP, LIMS, PLM)

- Work with technical teams on data migration, system upgrades, and issue resolution

- Troubleshoot application issues and provide production support

Collaboration & Stakeholder Management :

- Act as primary point of contact for business users and clients

- Collaborate with global teams across Pan India and USA

- Provide status updates, risk identification, and mitigation plans

Required Skills & Qualifications :

Mandatory Skills :

- 5 to 10 years of experience in QMS implementations

- 3+ years of hands-on experience with IQVIA SmartSolve

- Strong understanding of Life Sciences / Pharma / Medical Devices-domain

- Excellent knowledge of GxP regulations and compliance requirements

- Experience in techno-functional role-(configuration + business analysis)

Technical Skills :

- SmartSolve configuration and administration

- Validation documentation (IQ/OQ/PQ)

- Data migration and reporting

- Integration understanding (REST/SOAP APIs good to have)

Soft Skills :

- Strong communication and stakeholder management skills

- Ability to work independently and in global teams

- Excellent documentation and presentation skills

Nice to Have :

- Experience working with US and global clients

- Knowledge of CSV (Computer System Validation)

- Exposure to other QMS tools (TrackWise, Veeva QMS, MasterControl)

Education :

- Bachelors or Masters degree in Engineering, Life Sciences, Pharmacy, or related field

At Greymatter Innovationz, We offer :

- Motivating Work Environment.

- Excellent Work Culture.

- Help you to upgrade yourself to the next level.

- And More!!!

Requirements added by the job poster :

- Can start immediately

- Working in a hybrid setting