Quality Assurance

About the Role
Responsible for quality, compliance, and adherence to GMP standards across warehouses, CFAs, redressing sites, suppliers, and service providers. Covers QMS and GMP documentation, ISO audits (internal and external), complaint management, CAPA, deviations, change control, product release, and training. At the Senior Executive level, the role carries greater ownership of audits, agreements, and cross-site coordination.

Key Responsibilities

QA, SOP & Compliance Management

• Prepare, review, and implement QA SOPs and maintain QMS/GMP documentation across all sites in line with regulatory and organizational standards.
• Conduct risk assessments for QA activities and changes per the change control process; support QA projects aligned with organizational quality objectives.
• Initiate, monitor, and close CAPA, deviations, and change controls (via the Technical Change Control System) with proper documentation.

Product Release & Complaint Management

• Manage Finished Goods Shipment Release and issue RTM status in SAP for import shipments and warehouse-to-CFA/inter-CFA dispatches.
• Investigate and close product complaints (shipment damage, packaging defects, other quality issues); evaluate returned products and approve/reject re-introduction into saleable stock.

Quality Audits & Compliance Monitoring

• Conduct internal ISO audits and coordinate external ISO audits/certification visits of warehouses, redressing sites, CFAs, and vendors/service providers, ensuring documentation readiness.
• Review quality KPIs and self-inspection reports; support affiliate self-inspections and close observations on time.
• Represent QA in monthly regional meetings.

Warehouse, Storage & Risk Management

• Ensure storage facilities meet defined storage/handling requirements; review temperature-mapping and cold-chain data at defined intervals.
• Review qualification/validation reports for storage areas and packaging materials; monitor product destruction per procedure.
• Coordinate product recalls and mock recalls, with documentation and follow-up.

Vendor, Training & Redressing Activities

• Prepare and maintain Quality Agreements with vendors and service providers; monitor supplier, warehouse, redressing site, and CFA compliance against quality and GMP standards.
• Train warehouse, redressing site, and CFA personnel on QA guidelines, QMS, and local SOPs.
• Support redressing activities, including review of Job Orders and BPRs; guide teams on adherence to quality procedures.