• Mumbai City
  • Save Job
  • 13 - 15 Years
  • Posted : above 1 month

Job Description:

Key Responsibilities

  • Ensure ongoing compliance of product franchise marketed in India and Distributor based markets (Sri Lanka, Bangladesh, Nepal, Bhutan Maldives) to all applicable regulatory and Johnson Johnson (JJ) requirements
  • Responsible for end to end lifecycle management of product franchise that meets Health Authority and JJ requirements
  • Collaborate cross functionally to enable reliable supply of product to market that meets local regulatory and JJ requirements
  • Engage with cross functional team during developmentintroduction of new product or trade promotions to proactively identify riskschallenges in meeting the regulatory and quality system requirements Drive the team to identify probable solutions in order to mitigate the risks challenges
  • Review applicable documents, records for compliance to the standard procedures and requirements and provide approval for Product Release
  • Lead investigations, corrective and preventive actions for issues that havewould impact on productsprocesses 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 newrevision in the regulatory requirements and its potential impact on the business Develop mitigation plan and ensure readiness for timely compliance
  • 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 gapsrisks
  • Drive approval, qualification and monitoring of applicable suppliersservice providers and distributors
  • Governance of Resource Qualification and Training element and will be the TPO Co-ordinate and conduct trainings on applicable processes and procedures to the stakeholders
  • Lead Auditsassessments 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

Qualifications Education

GraduatePost-graduate level academic qualification, preferably in Quality Assurance, Pharmacy or other Healthcare Sciences

Experience and Skills

  • At least 13-15 years of working experience in the Corporate Quality Assurance function of a reputed Pharmaceutical, Medical Device or Cosmetic company, with direct responsibility of BusinessCommercial Quality Management System

  • Comprehensive knowledge of Regulatory requirements Quality Systems, Problem solving, Decision Making, Project Change Management

  • Proficiency in computer-based Quality System IT tools

  • Proficiency in computer-based Quality System IT tools

  • Proficiency in written oral English, good communication and interpersonal skills, sound business acumen, ability to work in a highly matrixed, multi-cultural global organization


Profile Summary:

Employment Type : Full Time
Industry : FMCG / F&B
Salary : Not Disclosed
Deadline : 07th Jun 2020

Key Skills:

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