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Role Description:
The External Supply Quality Supervisor is accountable for providing quality
assurance management of key contractors for Pfizer and for assuring that the
products supplied to our patients are manufactured, tested in accordance with
c-GMPs, the registration file and any additional country specific requirements.
To be responsible for on-site supervision for the whole production process and
test process at Pfizer Contractor to ensure the whole production process and
test process to be in compliance with Pfizer expectation and GMP requirement.
To review batch records and in-process control records to ensure the accuracy.
To support deviation/OOS investigating and participate into Quality system
maintaining work, such as PDOCS，supplier’s management, training system, QTS,
GMP inspections, Change Control, complaints and validation, internal audit and
other quality team work. To complete other associated work assigned by Quality
Lead.
This is highly independent position operating with minimal supervision,
interacting with middle levels of management both at contract manufacturers and
within Pfizer. Will spend a significant period developing relationships,
independently negotiating, developing, and communicating Pfizer quality
requirements with contract manufacturers.
Qualifications: Education - Experience - Additional Requirements
Minimally BA/BS Science, Engineering, or related technical discipline with at
least 5 years in a GXP setting.
At least 3 years of pharmaceutical Product Quality Management department
experience in a GMP environment.
Experience with external suppliers/contractors is preferred.
Deep understanding of sterile operation and/or oral operation and/or quality
control is required.
Advanced computer skills, MS Office and enterprise systems such as QTS and
Documentum platforms.
Command of English language required, and multi-lingual is beneficial.
Strong verbal and written communication including presentation skills.
Demonstrated ability to prioritize work, to act and work independently and to
report items as required to Team leader.
Demonstrated experience managing complex quality and compliance activities in
a manufacturing plant or with a contractor.
Developing ability to resolve conflicts.
Takes initiatives and is proactive, persistent.
Has a broad GMP and technical know-how to handle emerging issues.
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Work Location Assignment:？Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing