Opportunity to Job as a Senior Manager / Team Leader @ Pfizer
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Senior Manager / Team Leader
Purpose and Scope:
The incumbent and his/her staff will have total accountability for the quality of contract manufactured products, and compliance of Pfizer contract manufacturers in India. This includes providing quality assurance leadership to manage vendor issues arising at contract manufacturing sites, developing, implementing and maintaining fit-for-purpose quality systems for ongoing quality oversight of these contractors. The Senior Manager /Team Leader will manage a staff of colleagues that may include Executives, Assistant Managers and Managers.
Reporting to: Director, COQA India
Manage overall quality oversight of all contractors in India
Provide quality assurance leadership to manage complex quality and compliance issues arising at the contract manufacturing sites
Lead the development and negotiation of quality and technical agreements with contractors and user sites; ensure applicable quality provisions of supply and contract manufacturing agreements meet Pfizer requirements
Provide leadership to the establishment and implementation of fit-for-purpose quality systems at contract manufacturing sites in India for Pfizer products and non-Pfizer molecules
Help support in due diligence assessments of new contract manufacturers
cGMP assessments of contract manufacturers
Provide support to QO leadership in new products launches
Provide support to QO leadership in product and technology transfer projects
Support development, implementation and maintenance of internal quality systems within COQA
Support SLS surveillance testing issue resolution, and provide leadership to the troubleshooting of product quality, cGMP and regulatory compliance issues at contractors
Represent COQA in India with internal and external stakeholders on quality and compliance issue resolution
QO interface on business teams managing contractors in India
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