Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products.
What You Will Achieve
In this role, you will:
Ensure compliance & on-time implementation of corrective actions/preventive actions derived from Regulatory Inspections and Third party or Corporate Assessments through completion.
Perform Regulatory Observations Network Assessments (RONA) to identify gaps at site and implement CAPAs within agreed timelines.
Co-ordinate with Pfizer site Inspection Readiness and global Subject Matter Experts for Inspection Readiness activities.
Maintain the Inspection Readiness tracker and its timely update as per current information.
Preparation of the manufacturing IR Meeting slide deck to present in site meetings and leadership meetings
Responsible for coordinating governance meetings and notify any delays on time to management.
Provide data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status.
Lead the upstream compliance team to manage day to day support for manufacturing that includes CCF, CAPA, QRM and training etc.
Responsible to provide guidance and conduct QRM
Monitor the CAPA Life Cycle to ensure on time closure of CAPA and drive the metrics.
Track/ Trend CAPA metrics and provide feedback to management on periodic basis in relation to CAPA.
Develop strategy for improved compliance against the metrics and maintain systems to measure performance against established targets.
Here Is What You Need (Minimum Requirements)
Master’s degree in sciences/ Pharmaceutical sciences with at least 10 years of experience
Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry
Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
Strong collaboration, relationship management, and interpersonal skills
Strong people management experience
Excellent written and oral communication skills
Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent
Bonus Points If You Have (Preferred Requirements)
Strong analytical and problem-solving skills
Ability to work independently and make decisions
Excellent organizational and time management skills
Experience in interfacing with regulatory agencies during audits
Ability to drive continuous improvement initiatives
Work Location Assignment: On Premise
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