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 : Manager - QC
Job Description :
Janssen India, the pharmaceutical division of Johnson & Johnson India is recruiting for Manager Quality Control located in Mumbai.
The incumbent in this role will be responsible for :
• Delivery of stability analyses, data review and investigations on drug substance and drug product in accordance with ICH guidelines.
• Ensuring that the quality objectives of the organization are met.
• Ensuring availability of adequate resources to execute and deliver timely reliable data to the partners
• Partnering with different stakeholders for delivering on technical projects
Key Responsibilities :
• Responsible for the adequate qualified resources are available for the activities needed for performing testing within the lab
• Ensuring compliance to Quality agreements made with manufacturing sites & local regulations as applicable.
• Keeping an oversight on OOS/OOT investigations to ensure timely investigation and adequate disposition of results.
• Ensuring that all lab activities are performed in accordance to cGMP requirements.
• Ensure availability of necessary equipment, tools, materials for laboratory operations.
• Coordination with global groups for the development of guidance and policies with regard to stability. Participate in technical discussions
• Ensure implementation of COC’s as per defined timelines.
• Lead escalations linked to OOS/OOT results generated during stability analysis and any other issues linked to lab operations
• Keep close track and oversight on recurrent issues in stability lab and ensure necessary adequate actions are defined to prevent further occurrences
• Responsible for being spokesperson during internal and external inspection
• Responsible for overall quality and compliance with regards to handling controlled substances and ensuring that local /global regulations are adhered to
Candidate Profile
• PG in Science or Pharmacy
• Preferred: Lean / Process excellence Certification or Project management certification
• 7-10 years’ experience
• Experience of managing teams
• Experience of facing regulatory audits
• Basic knowledge of Small molecules manufacturing and testing technologies
• Ability to communicate
• Decision making skills and Quality Acumen
• Big picture thinking / able to work with process flows
Additional Information
Experience : 7-10 Years
Qualification : M.Sc, M.Pharm
Location : Greater Mumbai, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : QC
End Date : 10th February, 2020
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