Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Assistant Manager – Quality Management System
Position Overview:
• This role is responsible to work with the Manufacturing Plants (Internal/External), 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 J&J’s Global requirements and applicable Regulatory Standards.
• Drive compliance of all Local Operation Companies (LOC), Manufacturing (Internal/External) Sites and R&D 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 J&J forums/ meetings and provide voice of APAC sites during the development of Global systems/ procedures.
• Deploy Global initiatives (e.g., 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 J&J’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 (e.g. 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.
Candidate Profile
1. Graduate/Post-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.
Additional Information
Experience : 2 -4 years
Qualification : B.Pharm / Life Science / MBBS Graduate ; MBA
Location : Maharashtra Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Product Management
End Date : 10th October, 2019
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