Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : Scientist IM&S
Job Description
Provide brief and concise statement explaining the main purpose for the existence of this position. Provide a brief summary of the role.
EMEA Raw Material Regulatory Sr. Scientist which includes below responsibilities :
• Coordinate and ensure quality of the review & approval for Raw Materials & formula for regulatory clearance in Concerto through collaboration the external resources (IMED) and internal RMC team
• Regulatory approval for GCC (Global Change Control) related to raw materials and perform impact assessment for Raw material changes like alternate supplier qualification, supplier driven changes etc.
• Support to ingredient issues and policies for EMEA region under guidance from Global RMC Regulatory Lead
• Closely work with Regional Regulatory Affairs to implement new ingredient regulatory requirements in the portfolio and integrate to raw material and formula regulatory clearance process
• Support to data management team for impact assessment for changes in the raw material data
• Collaborate with local Regulatory Affairs (RA) team to understand the country specific Regulatory requirements and help the qualification team to manage the Raw material changes efficiently and in compliance.
• Bring in process improvement ideas and drive simplifications to create a strong relationship with key stakeholders.
• Develop an agile mindset within the team and drive agile new ways of working with stakeholders across R&D, Quality, and Supply Chain.
• Collaborate with RMC RA team, Stewardship and Regulatory Affairs to support anticipation of ingredients issues and defense
• Work with the team to define process, RACI and increase overall compliance to Chemical Regulations in EMEA
Responsibilities
50% Raw Material Regulatory Clearance, Ingredient Issue Surveillance and Support, Implement New Regulatory Requirements, Data Input and Management, and Support Ingredient Changes/Defense
25% Participate in various meetings with internal and external stakeholders
15% Review and approval of change control and perform impact assessments
10 Provide visibility of overall projects and team’s performance to reporting manager and provide insight on creating new opportunities for process improvements and team development
100% Total
Other Duties
Describe important tasks or duties, not mentioned above, that are performed infrequently and are not critical to accomplishing the essential functions of the job.
Candidate Profile
Consider and identify qualifications potential applicants must possess in order to be considered for the position. Basic Qualifications must be clearly stated, objective and relevant to this particular position. Required Minimum Education: Bachelors / Masters in Pharmacy, Cosmetic Technology / Chemical Engineering Other:- Required Years of Related Experience: 3-5 years in FMCG sector.
(Include any required computer skills, certifications, licenses, languages, etc.)
Proficiency in Microsoft office tools,
• Experience in change control management process
• Knowledge of raw materials and its impact on the personal care formulations
• Adequate knowledge of GxP & quality systems
• Regulatory Experience Preferred
• Excellent communication, organizational, and interpersonal skills
• Ability to collaborate with internal and external resources to meet project objectives.
• Understanding on raw material chemistry and its usage and function in finished products
• Proficiency in Microsoft office
• Ability to manage/resolve interpersonally challenging situations
• Ability to successfully navigate unknown/unforeseen challenges
Additional Information
Qualification : Bachelors / Masters in Pharmacy
Location : Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : IM&S
End Date : 25th March, 2022
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