Pfizer Manager Quality Operations in Kalamazoo, Michigan
This posting is for a position in the Drug Product QA unit. This colleague's responsibility is to ensure timely release of Drug Product batches, provide product support for market requests and regulatory filing changes, as well as timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).
Independently provide real time Quality impact assessments and decisions (24/7) on Drug Product issues as needed:
Ability to handle complex and detailed situations
Accurately assess consequences of decisions
Accurately assess potential Regulatory impacts on a Global basis
Immediately escalate issues with potential market or stability impact
Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.
Participates in QAR Gembas with customers and peers
Evaluates data and releases Pfizer produced products that conform to corporate, customer, and regulatory standards. Maintains associated test plans.
Evaluates product data annually and writes and/or reviews Annual Product Review Reports for approval by management.
Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary
Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations
Lead/Participate in QRM assessments that gain approval through Site and Area QO Management
Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc... as appropriate
Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts
SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns
Participates in internal GMP audits
Provides product knowledge and support for regulatory deficiency responses, regulatory annual reports, and the development of other regulatory submission packages.
Maintains knowledge of product filings to support inquiry responses from internal and external customers.
Effectively communicate complex technical issues to all levels of Management (including outside of Quality)
Actively demonstrate Pfizer leader behaviors
Education: BS in Chemistry, Biochemistry, Microbiology, Engineering or other science related discipline
Preferred: Experience at a drug product manufacturing site with deviation and lot release support.
Experience: Minimum 5 - 10 years pharmaceutical and Quality Assurance experience required.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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- Last Date to Apply for Job: 06/28/2018 Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.