Annual Product Records Review APRR Specialist
Annual Product Records Review APRR Specialist
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$ 66500 - 110900
1 Vacancy
Job Description
Use Your Power for Purpose
Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and riskbased compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizers dedicated and highly effective quality assurance and control team. You will serve as a primary contact for managing annual product record reviews. You will compile and assess data from various aspects of the quality system to identify trends issues and improvements while ensuring compliance with regulatory agencies. Based on the feedback received you will be relied on to suggest modifications to the existing manufacturing and packaging processes.
As an associate your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Compile and assess data gathered for Annual Product Record Reviews (APRRs): Laboratory Data (Chemistry Microbiological and Incoming Materials) Manufacturing and Packaging data (including rejected quarantine or reinspected lots) Supplier Quality data Investigations/CAPA data Stability data Retention Sample data Validations Change Controls Quality / Technical Agreements Field Alerts/Actions Complaints data and Regulatory review of submitted specifications.
Perform statistical analysis of the data and develop conclusions and CAPA recommendations based on the data analysis and quality system review.
Discuss the APRR data and trends with Senior Management and Regulatory Auditors.
Perform followup activities to coordinate the completion of corrective and/or preventive actions.
Write investigations and revise procedures as necessary.
Support regulatory inspections.
Any additional Quality System Support the Supervisor or Manager may delegate as a priority
Qualifications
MustHave
Quality Experience or may be reduced if the incumbent has one of the certifications such as ISO CQE or CQA.
Pharmaceutical Experience in an FDA Related Industry
Excellent verbal and written communication skills and attention to detail
Proficient with Microsoft Office
Capable of organizing data from multiple sources extracting key information and writing reports and summaries
Demonstrated technical writing skills
Strong critical thinking and problemsolving skills
Ability to work crossfunctionally with a diverse team
NicetoHave
ISO CQE or CQA certification
Experience in QTS Trackwise system
Experience in LIMS system
ASQ Certification
Experience with statistical software
PHYSICAL/MENTAL REQUIREMENTS
Stand up for up to 8 hours sit for up to 8 hours
Walking and climbing stairs
Responding to visual warning indicators audible warning indicators color or special visual indicators
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
First Shift Monday Friday
Work Schedule: 8am5pm
Overtime: As Required
Other job details:
Work Location Assignment:On Premise
Last day to apply: April 11 2025.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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 providers 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.
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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
