Senior Associate – Contractor Operations Quality & Compliance ()
Beschrijving:
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.”
Contract Operations Quality Assurance (COQA) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.
COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.
The person will be responsible for execution of Site Compliance activities for Contracted Dug products and drug substances including the execution of the regulatory portion of the change control process and provide regulatory support.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.”
Contract Operations Quality Assurance (COQA) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.
COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.
The person will be responsible for execution of Site Compliance activities for Contracted Dug products and drug substances including the execution of the regulatory portion of the change control process and provide regulatory support.
Responsibilities
Execution of the regulatory portion of the change control process in the Regulatory Compliance Change Manager (RCCM) system and PDM for product change controls initiated by contractors or impacting COQA managed contractors.
Provides regulatory support to successfully conclude responses to deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
Executes Regulatory Compliance Dossier Assessments and tracking of corrective actions.
Serves 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 coordinating supporting documentation and filing strategies associated with Regulatory submissions for COQA managed Drug Products.
Participates to Virtual Site Operating Teams as the Regulatory expert for the products supplied by the contractors and if required to participate to Site Quality visits at the contractors.
Coordinate SOP revisions, collecting data and metrics from our IT systems and managing master data in our systems
Managing routine Customer Quality complaints for commercial Drug Products in PCOM and interactions with the Contractor Quality organization for ensuring that the investigation reports are appropriate and acceptable.
Supports the data collection preparation for routine Site Quality Review Team meetings and participates to self inspections.
Qualifications
* BA/BS Science, Engineering, Pharmaceutical sciences or related technical discipline
* Minimally 5 years in a GXP setting (or 3 years with Masters degree)
* Advanced computer skills of MS Office applications and good knowledge of enterprise systems such as RCCM, PDM,SAP, QTS Trackwise , Documentum platforms is a plus.
* Command of English language required and multi-lingual is beneficial.
* Strong verbal and written communication including presentation skills
* Up to 10% travel required
* Shows strong negotiation skills and customer focus
* Is diplomatic in communication with internal and external customers
* Demonstrates ability to prioritize work, to act and work independently and to report
items as required to Team leader
* Takes initiative and is proactive
* Able to manage multiple projects
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