Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every single day, our more than 130,000 employees across the world are blending heart, science and creativity to deeply change the trajectory of health for humanity.
Janssen Research & Development area develops treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Principal Scientist Technical Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC new product development teams.
Janssen India, the pharmaceutical division of Johnson & Johnson India is recruiting for Manager Quality Control located in Mumbai.
- 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
- 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
- PG in Science or Pharmacy
- Preferred: Lean / Process excellence Certification or Project management certification
Experience and Skills:
- 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
Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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