Your Responsibilities :
The purpose of this role is to :
Lead stability activities associated with the Category R&D development programs and to ensure proper management of stability infrastructure based on the site where the incumbent is located.
Define category stability strategy accounting for regulatory classification of products, location of resources to enable execution, project timelines and budget.
Maintain a network of third party experts and contract laboratories who can assist with the resolution of stability issues and support stability study execution respectively.
Engage with Category R&D team to provide expert advice on stability challenges associated with active substances and products used by the category.
Write stability protocols accounting for the regulatory class of the product, dosage form and intended territories where the product will be commercialized.
Determine the stability study execution strategy (internal or external and location)
Review developmental (preliminary), clinical supply and regulatory stability data and provide updates to the Category project teams on progress, issues and anticipated shelf life
Where stability issues arise provide a clear functional perspective on root cause and potential remediation strategies
Review and approve stability reports written by stability execution teams, and where necessary directly write reports.
Write submission eligible documentation.
Assign product shelf life using accepted methodologies and write shelf like memoranda
Monitor all ongoing stability programs until completion and alert category to any issues.
Liaise with the Quality team to ensure data related to follow up stability program is available and is reviewed from a category R&D perspective.
Ensure proper management of stability infrastructure on the site where the incumbent is located.
Develop working practices and SOPs covering stability study management and execution.
Drive an understanding of product stability challenges and issues across the category R&D team
Basic qualifications :
Bachelor’s degree in Life sciences
Strong proficiency in English is required
Preferred qualifications :
7-10 years’ experience managing stability studies in FMCH or OTC industries.
Proven ability to plan and lead stability activities internally or externally, and to reconcile business, technical and compliance requirements for successful delivery.
Proven ability to lead successfully and influence others with minimal managerial intervention
Excellent written and oral communication skills.
Proven ability to create stability plans and associated reports for product development that reconcile, business, technical and compliance needs and that anticipate technical issues and include mitigation strategies
Working knowledge of contribution and impact of other functions (Analytical, Global Regulatory Affairs, Clinical) on stability programs
Mastery of Statistical application for Stability data evaluation and shelf-life determination
A good comprehension of GMP
Why GSK? :
Our Consumer Healthcare business develops and markets products in Wellness, Oral health, Nutrition and Skin health categories.
Our seven global power brands Otrivin, Panadol, parodontax, Poligrip, Sensodyne, Theraflu and Voltaren, include some of the most trusted and best-selling brands in the world.