Compliance Specialist Inspection Readiness

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 risk-based 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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Participates in regulatory inspections, assessments and customer audits, as appropriate. Participates in the development of regulatory inspection preparedness training.
• Support of the Inspection Readiness Program. Prepares the Inspection Readiness presentations, supports and participates the Inspection Readiness meetings and responsible for maintenance of follow up actions to ensure the actions are executed in a timely manner.
• Support of the Commitment Tracking Model of the CAPA Management system, including Initiator and Responsible Person.
• Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and, as needed, recommends appropriate corrective actions.
• Contribute to Compliance management team initiatives and objectives.
• Assist in the process of gathering, interpreting and applying and finding improvements to support Site Inspection Readiness.
• Support in preparation of SME in Inspection Readiness including Mock Inspection Area Walk-throughs.
• Implement and adhere to {Current} Good Manufacturing Practices {part of GxP} regulations and company policies.
• Author department SOP revisions as necessary.

Role Summary

Interfaces with site departments in the coordination of audit/inspection planning and post audit/inspection activities; including but not limited to, fulfilling pre-requests, scheduling staffing support of the audit/inspection, active participation in the audit/inspection, writing responses, evaluation of robustness of responses and CAPAs received from departments and submitting responses to agency/ customer. As needed, participates in self-audit/inspection preparation. ​

• Bachelor's Degree
• 5+ years' experience
• Strong knowledge and understanding of cGMP Quality Systems
• Good technical writing skills, and communication as well as presentation skills
• Working knowledge of Microsoft Office

• Master's degree
• Project Management experience
• Background in Quality Control, Quality Systems and/or Manufacturing experience

PHYSICAL/MENTAL REQUIREMENTS

Office job involving use of a computer with additional gowning requirement as needed.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Additional support outside normal business hours may be required (e.g. in support of inspections or key projects)

Work Location Assignment:Hybrid

Last Date to Apply: August 5 2022

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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 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.

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.