Pfizer New Product Quality Manager Pfizer Essential Health in Chennai, India
Supporting the Pfizer Essential Health business unit (formerly Pfizer's Global Established Pharmaceutical (GEP) organization) the Manager of New Product Quality will be responsible for supporting and delivering on assigned programs in the Pfizer Essential Health Portfolio. Responsible for quality oversight of the development and enhancement of new and existing assets of the Pfizer Essential Health portfolio. As the quality representative responsible for representing Pfizer Global Supply, this individual will be the quality resource assigned to the development teams responsible for the development and commercialization of generic injectable products, biosimilar pharmaceuticals, anti-infectives and global expansion of commercial assets. Additionally, he or she will, identify development program risks pertinent to quality and compliance, working to resolve risks or liaise with partners in quality to drive resolution/mitigation throughout the entire development lifecycle of a program or asset (product). The development lifecycle is defined as starting with concept and ending with the commercial launch of the product.
During the product development lifecycle, they will oversee quality attributes related to characterization, specification development, formulation process definition, identification of critical process parameters and critical quality attributes.
Key responsibilities for the role include but are not limited to: technology transfer, execution registration batches, clinical batch manufacturing, support for clinical activity, stability, development investigations and identification of CA/PA, supplier and contract manufacturing organization qualification and management during development lifecycle, Pre-Approval Inspection Readiness for both internal and external suppliers, analytical method transfer and risk assessment of both processes and products.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.