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.
J&J Medical India (JJMI) is the market leader in the Medical Company Devices Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women’s health, minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.
Post : Manager - Quality Control
Job Responsibility:
• Management and Leadership in the Quality Control environment.
• Managing QC resources to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers.
• Ensuring all Quality Control activities are conducted in accordance with government regulations, safety requirements, Enterprise, Sector and Company policies.
• Ensuring the appropriate oversight and guidance for laboratory investigations including reviewing investigations to ensure that reports are consistent, complete and in alignment with applicable standards and procedures with appropriate content and references.
• Ensuring cGMP compliance in all aspects of the Quality Control functions.
• Oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems.
• Oversight of all Laboratory Quality Systems including Laboratory Change Management activities.
• Monitoring laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists.
• Monitoring the progress and process for troubleshooting and investigation studies for laboratory issues to ensure appropriate and consistent use of investigative tools and problem solving techniques.
• Assessing new technology and laboratory automation in collaboration with Regional Laboratory Leaders to increase laboratory efficiency, reduce testing time, reduce data variability, minimize chemical consumption and reduce waste.
• Maintaining knowledge of the regulatory trends related to relevant laboratory testing.
• Communicating and elevating critical business related issues as well as opportunities to senior management.
• Planning, promoting and organizing required training activities related to different laboratory testing areas.
• Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices.
Skill and Behavioral
Functional competencies:
• QMS: In depth knowledge of tools for investigation of OOS / NC, Audit trail reviews and capabilities of analyzing its impact assessment.
• Cross Functional coordination: Coordination skills with all stake holders.
• Qualification and Certification: Process experience. Overall knowledge of Product / Business priorities/Projects. Authority of decision making base on facts.
Professional Competencies
• Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management.
• Quality & Compliance: Quality Mindset, Compliance Orientation, Environment Health & Safety
• Business Fundamentals: Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation,
• Business Partnering: Influencing, Change Management, Time Management, Global Mindset & Management
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Candidate Profile
Education: Post graduate in Chemistry / Microbiology or Pharmacy Post Graduate. Preferably trained Internal Auditor as per ISO-13485:2003
Experience : Minimum 10 to 12 years of experience of Quality Control and/or Quality Assurance Medical Device or Pharmaceutical industry. Preferably FDA approved either in Chemical or Microbiology. Minimum 5 years of experience in Supervisory or Managerial cadre.
Additional Information:
Location: Maharashtra-Aurangabad
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality Control
Job Code: 1700212736W
End Date: 19th January, 2018
To Apply Online Click Here
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