Pfizer Quality Manager in McPherson, Kansas
Quality Field Alert Manager performs a comprehensive review and disposition of the information collected during the investigation of the product complaints in accordance with 21 CFR 211.198. In addition to complaint disposition this position requests written medical assessments from corporate Global Product Safety and submits initial, follow-up and final Field Alert Notifications (FARs) to the FDA in accordance with 21 CFR 314.91 when Hospira becomes aware of any event that may affect marketed drug products manufactured or distributed in the US. This position also assists with the recall process for Hospira McPherson products.
Provides compliance oversight for all product complaint and manufacturing investigations relating to Field Alert Report Notifications and Area Quality Review Team executive summaries assuring that thorough root cause evaluations are performed.
Collaborates with complaints and manufacturing investigators to ensure the appropriate level of detail is included in the investigation to ensure proper dissemination of information for regulatory reporting.
Participates in the triage of all product complaints received at Hospira McPherson to determine if issue escalation, containment actions or if a US FDA Field Alert Notification Form is required. This must be assessed within three (3) days of the Hospira awareness. Prepares initial Field Alert Notification Forms (FARs) based upon the initial analysis of product complaints that indicate the potential that marketed drug products manufactured or distributed in the US are impacted.
Prepares Follow up and Final FARs following the completion of root cause investigation.
Prepares Area Quality Review Team executive summaries.
Initiates recall forms for all McPherson Hospira products recalled.
Ensures accuracy of Metric and Tracking information for FARs and AQRTs (Area Quality Review Teams)
Ensures accuracy of Center tracking databases regarding FARs and AQRTs. Represents site at weekly AQRT data review meetings.
Provides data for preparation of Site Quality Review Team (SQRT)/ad hoc SQRT slides/data for monthly/weekly site meetings
Supports and maintains an environment that fosters communication and teamwork within QA and related departments.
Perform other duties as assigned by area management.
Bachelor's degree required
5-7 years of experience in the FDA regulated industry. Preferably 1-3 years of experience within Quality.
Strong technical writing skills
Strong interpersonal skills at all levels within the organization
High level of organizational skills and independence
Strong judgment and decision making ability
Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry
Grade: L-HSP 18
EEO & Employment Eligibility
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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.