Assistant Manager - Quality (GCP & PV)
F. Hoffmann-La Roche Ltd
8d ago

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
  • Internal Stakeholders

    Medical, Access, Value, PACE, Legal, Compliance Community, Legal, People & Culture, Regional and IQM team, PDQA team.

    External Stakeholders

    Along with PV & MAP SME, Direct Markets (Sri- Lanka, Nepal, Bhutan), Business Partners managing products or marketing of brands for Roche India, Distributors & CFA’s, Service Providers for Medical Function (including GCP and PV service providers), external audit group / SP

    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
  • Roche Pharmaceuticals, India, has been disseminating scientific knowledge pertaining to innovative medicines to the medical fraternity.
  • We have products in therapeutic areas such as Oncology, Virology, Nephrology, Transplantation, Anemia... Not translated Arthritis.

    In recognition of its contributions in Oncology, Roche India has been awarded the †Best Oncology Company of the Year,' by Frost & Sullivan at the India Healthcare Excellence Awards for the years 2011, 2012 and 2014. Not translated

    Roche is an equal opportunity employer.

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