Supply Chain quality hub associatePfizer

Position Purpose: Actively support in establishing and sustaining the Product Quality System, mainly the Product Quality Complaints Process and/or Batch Release, and Quality Culture at the applicable Pfizer Country Offices (PCOs) under the Supply Chain Quality HUB Manager leadership.
Product Quality Complaints Management
Evaluate if the report represents a product quality complaint.
Perform follow up contact with the Intake group and/or the complainant to obtain the necessary and relevant information to process the complaint.
Intake and Triage of complaints from the local market(s), assign class and criticality to the product complaint and forward them to the appropriate investigating Pfizer Global Source /Contractor Site(s) via the global complaints management system.
Support the management of the complaint samples, including the tracking of the samples.
Develop and issue response(s) to the complainant in a timely manner, when required.
Support answering the queries related to product complaints and the verification/evaluation of product quality complaints trends.
Support to evaluate the need of a Notification to Management and/or a notification to Regulatory Authorities, in/for the required market(s).
Support the activities related to the management of the Offline Contractor Site(s) investigations in the global complaints management system (investigations conclusion in the system).
Sustain additional and complementary alignments and trainings with the involved team(s)/department(s).
Product Disposition
Review Certificate of Analysis, COC and any other relevant information, of fully finished products
Review packaging artwork of fully finished products
Review temperature data for incoming shipments and assess any excursions as per Pfizer policy
Conduct transactions in Systems, Applications and Products (SAP), where required
Support the reception and management of Quarantine Alert Notices (QAN), depending on where the issue originated.
Product Returns
Evaluate the requirements under which returns can be taken back to saleable stock and support necessary actions, in cooperation with logistics and distribution center, where required.
Product Quality Incidents Management
Identify deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO(s) organization (Hub) and initiate the incident ́s investigation to completion.
Product Quality System
Support timely implementation of all applicable Product Quality SOPs within the PCO(s) and its impact in the SCQ activities.
Support adjustment/enhancement to local systems and processes, when required.
Participate in Quality Risk Assessments
Inspections and Internal Audit
Support Supply Chain Quality HUB Manager in preparation and coordination of Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities at the PCO(s).
Support tracking the implementation of the identified actions within agreed timeframes under leadership of Supply Chain Quality HUB Manager.
Metrics:
Prepare and report metrics
Ensure key quality metrics for quality systems are met.
REQUIRED SKILL SET
Able to work effectively with cross-functional teams and other stakeholders.
Respond to changes with agility, good discernment for prioritization and ability to consistently deliver on time based on given standards
Proficient in the use of digital tools/ systems (like Microsoft office/ SAP system)
Advanced English language communication skills, verbal and written.
Good knowledge of cGMP and regulatory guidelines for product disposition of pharmaceutical products.
Education
Bachelor ́s Degree in Biologics Sciences or equivalent (Pharmacy, Chemical Engineering, etc.) Licensed Pharmacist preferred but not required.
Experience
Minimum 4 years working in pharmaceutical industry, preferably in Quality Operations (cGMP, inspection, quality management systems, product disposition (including FDA/ Philippine Drug Enforcement Agency requirements), Product Quality Complaints (Medical Information, Pharmacovigilance, etc.) and/or pharmaceutical production, product research and development.
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
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Pfizer

Makati City, Metro Manila
Permanent
Full-time