Job Description

Why Patients Need You 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.

What You Will Achieve You will be a member of Pfizer's dedicated and highly effective in Quality Operations. Your contribution in compliance will help Pfizer provide safe drugs to patients.

Your technical skills will help us meet their accuracy specifications against established standards. As a Quality Compliance Associate, you will be involved in leading compliance initiative and you will be relied on to solve complex problems within your area of expertise. 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 Work with site leadership to develop and maintain a written Inspection Readiness (IR) Site Plan per the IR Center standard or equivalent Assist departments with improvement projects as they relate to inspection readiness and as identified during Site Self Assessments and walkthroughs Auditing external local suppliers for incoming materials (prepare annual plan of external audits with purchase department, audit execution and documentation and follow up with suppliers for closure of non-conformities) Support and prepare site for internal and external audits and regulatory inspections Be responsible for regulatory commitments/responses Work closely with CMC team to ensure site practices are aligned with registrations and keep CTD dossiers up to date Follow on changes and liaise with regulatory team for submissions Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Pfizer Quality Standards Oversee overall manufacturing operations to ensure its compliance with the approved SOP, PQS, current GMP, and applicable regulatory requirements Support, plan and maintain site quality risk management profile and escalate appropriately Support on investigations and participate actively in Notification to Management and AQRT/ESQRT process. Facilitate a communication forum/mechanism at the site where colleagues feel comfortable sharing opportunities for the enhancement of actions related to the life-cycle of GMP data Coordinate and participate in the Data Integrity "walkthroughs" by site leadership as defined in the site Data Integrity and Individual Accountability program Strategically influence the DI program in alignment with internal and external learnings and requirements Identify, summarize and communicate risks to the integrity of site GMP data, including recommended actions to reduce the same. Facilitate sharing of key program updates, challenges, changing regulatory and internal expectations Ensure investigations related to the integrity of GMP data at the site are notified as appropriate (and to Corporate Compliance e.g., Referable Compliance Issue RCI, if required) and are documented in the site GMP investigation system Ensure other deviations from compliance with data integrity of ancillary systems/processes (i.e. non-GMP, such as EHS), that are potential RCIs are report to Corporate Compliance Provides Data Integrity program risk information as an input to the IR process Ensure a training Curricula is established for site colleagues which ensures the establishment and maintenance of a contemporary, example-based understanding of good data management practices Facilitate site leadership learning sessions to ensure base-line awareness of DI requirements Focus on Safety and GMP Compliance as operational priorities Guide, advise and coach the team on the principle and practices of good data management (ALCOA) Being a role model to support a positive compliance culture and vigilant for potential actions or behaviors that could result in breaches of GMP compliance or data integrity principles

Qualifications

Must-Have Pharmacist or Bachelor's Degree 3+ years' experience Experience in Regulatory, Production Operations, Quality Control, Quality Assurance & Compliance. Advanced analytical skills will be required to make competent decisions based on a review of analytical data. Demonstrated leadership qualities with trouble shooting abilities in manufacturing area. Quality operations technical knowledge. Effective communications skills required, both written and verbal. Requires strong interpersonal skills and the ability to handle multiple projects. Strong technical writing.

Nice-to-Have Relevant pharmaceutical experience. Experience using data analysis computer tools and statistical analysis Knowledge of production operations and analytical data records Audit certification

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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