Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products. The organization is comprised of more than 250 operating companies with over 128,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world
Post : Manager – Business Quality
Job Responsibilities:
- 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 in order to mitigate the risks/ challenges.
- Lead investigations, corrective and preventive actions for issues that have/would impact on products/processes or compliance to regulations or company standards.
- Lead 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.
- Lead end-to-end complaint vigilance process, periodic review of complaints with appropriate local and regional stakeholders and track actions identified to address adverse trends.
- Lead product risk management process with appropriate stakeholders and ensure appropriate risk assessment and management for products.
- Interact with Marketing and Sales team to review new marketing strategies like Digital, Social & E-commerce which would be the top-line growth drivers. Identify risks with these initiatives and develop mitigation plan for the gaps/risks.
- Drive approval, qualification and monitoring of applicable suppliers/service providers and distributors.
- Lead Audits/assessments for Local Operating Company.
- Manage Field Actions and Escalations.
- Conduct Mock Product 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 :
1).Technical qualification: Bachelor/Post Graduate in Science.
2.) Required skills: Comprehensive knowledge of Regulatory requirements & Quality Systems, Problem solving, Decision Making, Project & Change Management, Interpersonal & communication skills.
3).Minimum 10 years of relevant experience in Pharmaceutical/FMCG industry is preferred.
Additional Information:
Experience : 10 years
Qualification: B.Sc, M.Sc
Location: Maharashtra-Greater Mumbai
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Quality (Generalist)
End Date : 5th Feb., 2017
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