• Mumbai City
  • Save Job
  • 7 - 8 Years
  • Posted : above 1 month

Job Description:

Position Overview

  • This role is responsible to work with the Manufacturing Plants (InternalExternal), Local Operating Companies and various partner Functions within the Asia-Pacific Region to deploy Johnson Johnson s Enterprise Policies Standards and drive the Quality Management System viz, Quality System Management Review, Change Control, Document Management Control, Training governance, Investigations CAPA Management, Escalations, Internal Audit, Regulatory Inspection preparedness etc
  • The role also involves driving systemic improvements through various initiatives at Asia-Pacific Regional level and liaising with global regional local representatives to develop upgrade Quality System Procedures, Processes and Systems

Key Responsibilities

  • Effectively deploy new or revised Quality System elements in Asia-Pacific (APAC) region to ensure continued compliance with JJ s Global requirements and applicable Regulatory Standards

  • Drive compliance of all Local Operation Companies (LOC), Manufacturing (InternalExternal) Sites and RD units in APAC to deliver all the Quality Metrics, as defined at the Global level, through periodic training, monitoring and issue resolution

  • Represent Asia Pacific region in the Global JJ forums meetings and provide voice of APAC sites during the development of Global systems procedures

  • Deploy Global initiatives (eg, TrackWise deployment) at the Regional level through coordination with various functions, impact assessments and training to the relevant teams

  • Develop, review and update Regional procedures in-line with JJ s requirements and applicable Regulations within the APAC region

  • Act as a champion for various IT systems such as Symphony, TrackWise, PQMS, Document Management System etc by providing user training and then continued governance

  • Drive continuous improvements in compliance levels by conducting Regional CAPA Review Board meetings, Metrics reviews, establishing CoP (Community of Practices) etc

  • Conduct periodic trainings on Global and Regional procedures to improve awareness and understanding of users on these procedures

  • Ensure timely accurate reporting of Quality System events (eg Product Recall, Health Authority Inspections, Compliance to standards) of APAC region and applicable sites to the Enterprise

  • Provides Quality Systems Inspection Audit support and readiness


Competency Requirements

1 GraduatePost-graduate level academic qualification, preferably in Quality Assurance, Pharmacy or other Healthcare Sciences Lead Auditor Certification for ICH Q10, ISO 9001, ISO 13485, etc will be an added advantage

2 At least 7-8 years of working experience in the Corporate Quality Assurance function of a reputed Pharmaceutical, Medical Device or Cosmetic company, with direct responsibility in the area of Quality Management System

3 Proficiency in computer-based Quality System IT tools

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

5 Self-directed working and strong result orientation


Profile Summary:

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

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