Pfizer Jobs in Wichtia – Quality Engineering Investigator

Job Description:

Act as a plant resource to standardize investigations through process evaluation, template development and training. Provide Quality Engineering guidance to investigations, corrective and preventive actions (CAPA) and Manufacturing to support plant activities. Evaluate process/procedure changes as necessary and assure changes are implemented in associated plant procedures. Support CAPA program requirements to assure timely closure. Promote consistency in investigation practices across corporate and plants. Actively participate in Pfizer improvement projects.

Job Responsibilities:

• Perform and document investigations regarding plant issues and critical defect audit failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary to complete the investigation.
• Conduct personnel interviews and system reviews.
• Act as an unbiased investigator with questions surrounding the specific issue. Perform and document investigations regarding plant issues and critical defect audit failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary to complete the investigation.
• Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue
• Evaluate corrective actions in regards to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur.

Job Requirements:

• Strong oral, written, communication, presentation and interpersonal skills.
• Capable of interfacing with multiple levels of people within the organization, including Corporate management, third party customers, and plant personnel.
• Superior technical writing and problem solving skills required. In-depth knowledge of exception documentation procedures and requirements.
• Must be capable of organizing data from multiple sources, extracting key information and documenting investigation in gQTS software.

Qualification & Experience:

• Requires bachelor’s degree in scientific field or equivalent pharmaceutical experience (4+ years of experience)
• Requires a minimum of 2 – 5 years of CAPA, investigations, or manufacturing quality assurance experience, or a minimum of 6 – 8 years manufacturing/technical experience in a pharmaceutical or regulated GMP environment.

Job Details:

Company: Pfizer

Vacancy Type:  Full Time

Job Location: Wichita, KS, US

Application Deadline: N/A

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