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Post : Assistant Manager - Quality (GCP & PV)

Job Description:
• To lead the QMS initiative for the Indian affiliate in managing compliance, training, audit/ inspection readiness for medical (GCP & PV), MAP teams & aligning QMS at the Indian affiliate with the global best practices of Roche.
• Monitor Regulations, processes/ procedural documents, Compliance Metrics, Training, systems, tools
• Monitor, prepare & coordinate for Audits/ Inspections & post conduct actionable (for Affiliate and Direct Markets)
• Report changes to ensure processes updated/ aligned where required
• Report Deviations to processes and relevant actionable to prevent
• Report product / data quality issues & Monitoring & evaluation of process/ program effectiveness
• Risk Assessment, Mitigation plans
• Build compliance, implementing learning from other affiliates
• Driving collaboration through establishment of a strong connect with Internal stakeholders to drive collaboration

Functional Competencies
• Knowledge of quality management systems
• Knowledge of Roche (GCP- PV) processes, procedural documents and tools
• Knowledge of GCP&PV
• Knowledge of Clinical Project Management
• Knowledge of Health Authority Requirements

Behavioural Competencies
• Collaboration / fostering teamwork, establishing focus
• Exhibition of Roche Leadership Competencies and Roche Core Values
• Provide guidance / implementable solutions via Analytical thinking
• Exhibit Quantum self
• Patient centricity in decision making
• Critical & Detailed Evaluation
• Unbiased & accurate reporting
• Learn & implement Ethical practices

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality (GCP & PV)
End Date : 5th March, 2019