Manufacturing QMS Manager

Quality Management System

• Lead the implementation, maintenance, and continual improvement of the site's Quality Management System.
• Ensure compliance with cGMP requirements, ICH guidelines, WHO GMP, US FDA, EU GMP, MHRA, and local regulatory standards.
• Develop and maintain quality policies, SOPs, procedures, and quality manuals.
• Monitor QMS effectiveness through quality metrics and trend analysis.

Deviation, Investigation & CAPA Management

• Review, approve, and monitor deviations, non-conformances, investigations, and OOS/OOT events.
• Ensure root cause investigations are scientifically sound and completed within timelines.
• Monitor CAPA implementation and effectiveness verification.
• Drive continuous improvement based on investigation outcomes and quality trends.

Change Control Management

• Manage site change control processes for manufacturing processes, equipment, facilities, utilities, computer systems, and quality systems.
• Ensure proper risk assessments and impact evaluations are conducted.
• Monitor timely implementation and closure of approved changes.

Documentation Management

• Oversee document control systems including SOPs, specifications, protocols, reports, master batch records, and quality documents.
• Ensure periodic review and revision of controlled documents.
• Maintain compliance with Data Integrity and ALCOA+ principles.

Audit & Inspection Management

• Plan and coordinate internal quality audits and self-inspections.
• Facilitate customer, corporate, and regulatory audits.
• Lead inspection readiness activities and coordinate responses to observations.
• Track effectiveness of corrective actions arising from audits and inspections.

Quality Risk Management

• Implement Quality Risk Management (QRM) programs in accordance with ICH Q9.
• Facilitate risk assessments using FMEA, HACCP, Fishbone Analysis, and other risk tools.
• Ensure risk-based approaches are embedded within manufacturing and quality processes.

Product Quality Review (PQR/APQR)

• Coordinate Annual Product Quality Reviews (APQR/PQR).
• Analyze process capability, product quality trends, deviations, complaints, and stability results.
• Recommend improvements to enhance product and process robustness.

Training & Compliance

• Manage GMP and QMS training programs.
• Ensure employees are qualified and trained on quality systems and regulatory requirements.
• Monitor training compliance and effectiveness.

Quality Metrics & Management Review

• Prepare and present quality performance reports to site leadership.
• Develop and track KPIs for deviations, CAPA, change controls, complaints, audits, and trainings.
• Conduct Management Review meetings and follow-up actions.

Cross-Functional Collaboration

• Partner with Manufacturing, Engineering, Validation, Warehouse, QC, Regulatory Affairs, and Supply Chain teams.
• Support quality culture initiatives and operational excellence programs.

Interested candidates can send resumes to [email protected]