QA/ QC System Expert

About the role

The QA Digital Expert is responsible for driving digital transformation initiatives within the Quality Assurance function. This role focuses on implementing, managing, and optimizing digital quality systems (eQMS, LIMS, MES) to enhance compliance, data integrity, and operational efficiency in alignment with GMP and regulatory requirements.

Role Responsibilities

Project Start Up Phase:

• Timely input to the process/ equipment s quality system requirements.
• Ensures that appropriate systems are implemented and maintained
• Ensures the right validation protocols are developed for the new site validation and documentation.
• SAP QM Master data Set Up
• SAP QR Lane Set Up
• Smart LIMS Set Up for Lab Instruments
• Proficy Set Up
• VEEVA Set Up For Plant and regulatory Licenses

Once the site is operational: Commercial production

1. Digital Quality Systems Implementation

• Lead implementation and enhancement of digital QA systems (eQMS, LIMS, QMS software, TrackWise, Veeva, etc.).
• Collaborate with IT and QA teams to define system requirements and workflows.
• Ensure smooth system integration across manufacturing, QC, and QA functions.

2. Data Integrity Compliance

• Ensure compliance with ALCOA+ data integrity principles and regulatory expectations (USFDA, MHRA, EU GMP).
• Design and monitor data governance frameworks.
• Conduct periodic data integrity audits and risk assessments.

3. Process Digitalization

• Drive paperless initiatives (electronic batch records, electronic logbooks, digital workflows).
• Automate quality processes such as deviations, CAPA, change control, training management.
• Improve data visibility through dashboards and reporting tools.

4. System Validation Compliance

• Ensure CSV (Computer System Validation) compliance for all GxP systems.
• Review and approve validation documentation (URS, IQ/OQ/PQ, validation reports).
• Maintain audit readiness for computerized systems.

5. Analytics Continuous Improvement

• Utilize data analytics to identify trends, risks, and improvement opportunities.
• Develop KPIs and dashboards for quality metrics.
• Support predictive quality and risk-based decision-making.
• Should be able to handle team

6. QA Document management

• Lab Equipment PM and Calibration Planner
• Reviews Operational, Quality etc SOP
• Reviews QMS Document as and when needed
• Issue and retrieval of control copies

Basic Qualifications

• Bsc/Msc Science Graduate with 3+yrs of experience
• Experience in the healthcare/FMCG industry in the area of manufacturing, quality or technical operations.
• Experience with eQMS
• Knowledge of LIMS, SAP, Proficy systems
• Strong understanding of Computer System Validation (CSV / CSA)
• Familiarity with data integrity principles (ALCOA+)
• Basic understanding of analytics / BI tools

Preferred Qualifications

• Detail-oriented with analytical mindset
• Excellent documentation and compliance knowledge
• Problem-solving and decision-making skills
• Effective communication and stakeholder management

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.