Company: Bristol Myers Squibb
Post: Quality Responsible
Location: Mumbai
Job description
Ensure that a Quality Management System is implemented and maintained in the local market, including:
- Acts as the local Quality Responsible Person for GDP in accordance with Market regulatory requirements
- Maintains Quality System Documentation: procedures and records
- BMS Policy/Directives/SOPs impact assessment and implementation
- GDP and Local regulations impact assessment and implementation (Manage the process of assessment for the new directives -Regulatory surveillance-
- Maintain up-to-date Quality Manual for BMS India.
- Medical samples Quality distribution oversight.
- Driving improvement opportunities in the areas of regulatory compliance, quality performance metrics, agility, responsiveness, and customer / consumer-centric activities.
- Facilitate that BMS requirements are implemented in the Local Distribution Centre for Warehousing (including storage) facilities, Secondary packaging facilities Transportation distribution processes
- Support the Global Quality Audits in the market
- Ensure readiness for HA inspection in local entity and leading HA inspection
Expected area of competence:
- Implementation and maintenance of a quality management system, for the distribution activities with BMS products in India
- Escalate by communicating quality issues and decisions, which impact the business.
- Ensures compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation.
- Identify continuous improvement activities for more effective Quality systems across the organization.
- Participation in company business growth objectives for quality alignment.
List of minimum requirements and Required Competencies
- Must possess a bachelor's degree in Sciences, preferably in Pharmacy
- Minimum of 5 - 7 years of progressive experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
- Knowledge and experience in pharmaceutical health care operations, quality control, quality assurance compliance, distribution and international regulations are essential.
- Proficient in GDPs and regulations promulgated by the FDA, EMA or equivalent Regulatory Agencies, and requirements for pharmaceutical products distribution.
- Ability to effectively communicate ideas to others to accomplish challenging goals and objectives
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