Pfizer careers Associate, ESQ BA/BS in Science, Engineering, Pharmaceutical Sciences Apply Now
Role
Description
Our
Global Quality Operations Mission is “to be a proactive partner, driving a
science and risk-based compliant quality culture that is flexible, innovative,
and customer oriented, maximizing the contribution of Quality Operations to Our
Path Forward initiatives.”
External
Supply Quality (ESQ) drives excellence in Quality by maximizing our Partner
collaboration to ensure Patients confidence in our Products.
ESQ
is responsible for the Quality management of approximately 400 contract
manufacturers, packagers, and supply partners globally. The person will be
responsible for regulatory change management activities as a Site Compliance
Network Member (SCNM), and management of routine complaints for the Drug
Products and Drug Substances (APIs) manufactured globally.
Responsibilities
Initiate,
review and approve regulatory changes through the PDM for changes initiated by
or impacting ESQ managed contractors.
Provide
support for the closure of the deficiency letters and CMC Commitments,
Regulatory requests for Renewals, New Product registrations and Post approval
variations.
Serve
as the main point of contact for the Global Chemistry, Manufacturing and
Controls (GCMC) department or Local Regulatory Affairs in the Pfizer Country
Offices (for Single market products) for the various regulatory activities
involving the ESQ managed contractors.
As
the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or
similar meeting for ESQ managed contractors and if needed, participate in Site
Quality visits at the contractors.
Manage
routine Customer Quality complaints for commercial Drug Products in CITI and
work in collaboration with the ESQ Contractor Quality Lead for ensuring that
the investigation reports are appropriate and acceptable. Ensure timely closure
of complaints and alerting the appropriate colleagues for the confirmed
complaints.
Qualifications
Min.
BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical
discipline
Min.
3 years of experience in GXP setting and/or Regulatory Affairs role
Advanced
in computer skills such as MS Office applications and good knowledge of
enterprise systems such as RCCM, PDM, QTS Trackwise, Documentum platforms, SAP
Good
command of English language and multi-lingual is a benefit
Strong
verbal and written communication skills including presentation skills. Able to
work in diverse multi-level, cross-divisional and multi-cultural working
environment
Show
strong negotiation skills and customer focus
Is
diplomatic in communication with internal and external customers
Demonstrate
ability to prioritize work, manage multiple projects, act and work
independently and to report items as required to Team Leader
Take
initiative and proactive
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