Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.
Post : Officer – Business Quality
Job Description
- Collaborate cross functionally to enable reliable supply of product to market that meets local regulatory and company requirements.
- Engage with cross functional team during development/introduction of new product or trade promotions to proactively identify risks/challenges in meeting the regulatory and quality system requirements. Drive the team to identify probable solutions to mitigate the risks/ challenges.
- Involve investigations, corrective and preventive actions for issues that have/would impact on products/processes or compliance to regulations or company standards.
- Involve in effective deployment of Company standards & procedures through gap assessment and implementation of action plans.
- Collaborate with Regulatory Affairs & Legal team to identify new/revision in the regulatory requirements and its potential impact on the business. Develop mitigation plan and ensure readiness for timely compliance
- Support in Training management
- Support in end-to-end complaint vigilance process, periodic review of complaints with appropriate local and regional stakeholders and track actions identified to address adverse trends.
- Involve in product risk management process with appropriate stakeholders and ensure appropriate risk assessment and management for products.
- Involve in qualification and monitoring of applicable suppliers/service providers and distributors
- Support in Audits/assessments for Local Operating Company.
- Support in Field Actions and Escalations
- Support in Mock Recalls to ascertain traceability of products is maintained in distribution chain as required by the local regulation and company requirements.
- Monitor, trend and report key performance indicators on periodic basis
Candidate Profile
Bachelor of Pharmacy (B. Pharm)/ Master of Pharmacy (M. Pharm) or any equivalent advanced degree
Required skills: Knowledge of Regulatory requirements & Quality Systems, Interpersonal & communication skills
Additional Information:
Experience:- 2-4 years
Qualification: B.Pharm, M.Pharm
Location: Mumbai
Department: Pharma
Job Function: Business Quality
Requisition ID: 1700170840W
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