Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives.
Post : Assistant Manager - Business Quality
Job Description
Responsible for ensuring robust compliance of the Local Operating Company (LOC) with the applicable regulations as well as with the company standards/policies, timely & effective deployment of the Quality System elements (planning, management & execution), governance of the Commercial Suppliers & Distributors and enabling the various “go-to-market” strategies of the Commercial organization in compliance with regulations.
He/She will also be responsible for advancing compliance understanding among the stakeholders. He / She will have accountability to implement Quality System harmonization strategies, and execute associated systems, processes, programs/initiatives and practices. This role will drive programs that help continuous improvement of the BQ organization’s effectiveness & efficiency. The incumbent will be expected to demonstrate influential leadership, through collaboration with different functions/levels of the organization.
He / She will report solid line to the Business Quality Head for India Consumer business.
Key Responsibilities:
• Strengthen compliance of the LOC with the regulatory requirements and Johnson & Johnson standards.
• Drive robust implementation of Quality Management system and ensure full compliance to Quality Policy, Enterprise Standards, Worldwide Procedures and Guidelines.
• Participate in global and regional procedure reviews to ensure applicability for LOC execution, gap assessment and mitigation plan execution
• Support BQ Lead to effectively conduct Management review for LOC, Product review, Quality Review board, gap assessment for changes in regulatory requirements, Product discontinuation Escalation and Field action for local company.
• Lead investigations, CAPA for issues that have/would impact products/processes or compliance to regulations or J&J requirements.
• Support commercial partners in driving effective Change Control and impact assessment processes.
• Establish and deploy quality governance model for the Commercial Suppliers (GxP related service providers) and Distributors, thereby minimizing the regulatory compliance risk to the business.
• Ensure applicable records are retained as per the local regulatory/Johnson & Johnson requirements.
• Provide hands-on Training to new users especially in the commercial team, on various systems like Symphony, GSS, Compliance Wire, Trackwise, etc., and maintain their records.
• Be GxP training Coordinator and Training Process Owner (TPO) for the India LOC.
• Lead preparedness of Local Operating Company for Audits. Actively participate in the external Regulatory / Health Authority Inspections.
• Ensure implementation of effective complaint vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS and track actions identified to address adverse trends.
• Monitor, trend and report key performance indicators (KPIs) on periodic basis.
Candidate Profile
Graduate or Post Graduate preferably in Chemistry, Pharmacy or other Healthcare science.
At least 5-7 years of working experience in Quality System of a reputed pharmaceutical/cosmetic/food company having thorough knowledge of Quality System and Regulatory requirements.
Proficiency in English language, good communication and interpersonal skills, with ability to work in a highly matrixed, multi-cultural global organization.
Proficiency in handling Computer-based Quality System tools.
Additional Information:
Experience: 5-7 years
Qualification: B.Sc. / B. Pharm
Location: Maharashtra-Greater Mumbai
Functional Area: Quality (Generalist)
Industry Type: Pharma
End Date: 30th March, 2018
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