Act as a Corporate and plant resource to standardize investigations through process evaluation, template development and training. Provide quality engineering consulting (to include investigations, CAPA and training) to support Corporate and plant activities. Evaluate process/procedure changes as necessary and assure changes are implemented in associated plant procedures. Track, trend, and act on CAPA program requirements in a systematic and effective way to assure timely closure. Promote consistency in investigation practices across Corporate and plants. Review and evaluate sensitive, confidential information and develop recommendations for use by plant Quality and Corporate Quality management. Actively participate in Six Sigma projects.
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.
Supervise the Quality Investigator I’s and II’s by reviewing and approving low and medium level investigations.
Evaluate corrective actions in regards to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur. Perform follow-up activities to coordinate the completion of corrective and/or preventive actions. Perform effectiveness checks for investigations. Design studies as needed to gather critical data for investigations and/or corrective actions.
Track, on a daily basis, the progress of all investigations as they pertain to Exception Reports/Quality Assurance Reports. Report progress in the weekly department meetings and Product Flow Optimization ( PFO) meetings.
Remain current in regulatory expectations and industry practices regarding investigations and CAPA.
Requires Bachelor’s degree in scientific field or equivalent pharmaceutical 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.
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 detail into the SmartCAPA software.
Must have project management or project development experience within pharmaceutical, medical device or related healthcare industry with demonstrated successful results.
Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox)
Experience using data analysis computer tools and statistical analysis is preferred.
Experience working in a cross-functional, matrix environment. ASQ Certified Quality Engineer and Six Sigma Green Belt preferred.
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.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Other Job Details:
Last Date to Apply for Job: April 24, 2019
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.