Pfizer
Senior Associate, External Supply
Quality (ESQ) Min. BA/BS in Science, Engineering, Pharmaceutical Sciences
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 product
complaints for the Drug Products and Drug Substances (APIs) manufactured by
Contract manufacturers.
Responsibilities:
Initiate,
review and approve regulatory changes through PDM for changes initiated by or
impacting ESQ managed Contract manufacturers.
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 ESQ managed Contract manufacturers.
As
the Regulatory Compliance and Product Complaint Expert, participate in Virtual
Site Operating Teams (VSOT) (or similar) meetings for ES/ESQ managed Contract
manufacturers and if needed, participate in Site Quality visits at the Contract
manufacturers.
Manage
routine Customer Quality complaints for commercial Drug Products in PCOM 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 as per our procedure and Standard Work
guidance.
Support
and Perform Lot Disposition for Biotech products in collaboration with other
functions.
Qualifications:
Min.
BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical
discipline
Min.
5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years
with Masters degree)
Advanced
in computer skills such as MS Office applications and good knowledge of
enterprise systems such as PDM, QTS Trackwise, Documentum platforms
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
Able
to report remotely and deliver work independently
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 be proactive
Up
to 10% travel required
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