Sr Associate, SAP Quality
Sr Associate, SAP Quality
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Job Description
Use Your Power for Purpose
Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.
What You Will Achieve
In this role you will:
Oversee quality activities including change control systems and product change control oversight in collaboration with Regulatory Affairs and APR program management.
Support non-manufacturing functions strategic quality planning and manage performance metrics and quality goals.
Review and interpret metrics to provide input and assistance in determining action plans needed to maintain or improve compliance in the Change Management Quality System.
Perform Risk Assessments for Validation systems stay updated on current Regulatory trends and Pfizer Quality Standards and conduct Quality Assurance Professional (QAP) updates in the Quality Information System (QIS).
Manage calibration/maintenance service contracts with outside vendors maintain the calibration database and participate as an auditor in the internal audit program.
Support the site self-assessment program by conducting internal audits and walkthroughs ensuring follow-up on corrective/preventive actions assisting with Inspection Readiness and engaging with group teams to recommend improvements to equipment and laboratory processes.
Assist in creating clear and concise parent change records to support Good Manufacturing Practices (cGMP) changes.
Here Is What You Need (Minimum Requirements)
High school diploma (or equivalent) with 8 years of experience or associates degree with 6 years of experience or BA/BS with 2 years of experience or MBA/MS with any years of relevant experience
Proficiency in preparing and facilitating regulatory inspections
Prior experience in change management processes or process validation within a medical device or pharmaceutical company
Strong interpersonal skills for providing training
Excellent organizational abilities to manage shifting deadlines and responsibilities
Proficiency in MS Office Suite
Bonus Points If You Have (Preferred Requirements)
Demonstrated ability to learn and master new applications software
Experienced in auditing with Good Manufacturing Practices (also cGMP) regulated industries
Strong analytical and problem-solving skills
Strong project management skills
Effective communication and collaboration skills
PHYSICAL/MENTAL REQUIREMENTS
Able to work in flexible timings and hours due to Pfizer Digital demand
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Able to travel as needed to Pfizer Manufacturing and Distribution centers
Work Location Assignment:On Premise
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 E-Verify employer. This position requires permanent work authorization in the United States.
Required Experience:
Senior IC
Employment Type
Full-Time
