1+ months

Senior Site Investigation Specialist

Pfizer
Tunas, MO 65764
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+ Responsible for conducting and overseeing investigations generated by Tuas API Site. Assist to conduct root cause analysis using Pfizer investigation tools for major deviations and Out of Specification records generated at the facility during all phases of the production and testing process.

+ Perform quality incident review in Global trackwise System of all incidents generated by QC investigators or Operations Investigators.

+ Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the Pfizer Quality Standards (PQS).

+ Mentor investigators and QA team members for technical writing, investigation techniques, identifying realistic CAPAs.

+ Work closely with Quality Assurance and Investigators in timely completion of deviations, Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.

+ Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.

+ Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions related to deviations.

+ Provide direction, effective training (community of practice) for investigators at the sites, and day to day activities as relates to conducting investigations of the QARs and OOS.

+ Participate in cross-functional team discussion to identify effective corrective and preventive actions to improve process quality.

+ Manage Deviation review board (SQRT) on weekly basis to provide decisions on SQRT QARs.

+ Manage Site CAPAs and provide data for Site quality metrics.

+ Other duties and responsibilities as assigned by the Manger.



\#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
Posted: 2019-12-31 Expires: 2020-05-04

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Senior Site Investigation Specialist

Pfizer
Tunas, MO 65764

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