**Core Competencies: **
Quality System Knowledge:
- Understanding of pharmaceutical manufacturing, packaging, quality control and quality assurance operations.
- Thorough knowledge of regulations/guidelines, Good Manufacturing Practices and Good Laboratory Practices.
- Proven experience in management/handling of regulatory agency inspections.
- GMP Knowledge: Trained and experienced in GMP fundamentals of operating a compliant facility.
- People Management: Ability to lead a team and delegate/assign work and tasks.
- Problem Solving: Ability to investigate, identify root cause and preventative measures using appropriate tools.
- Technical Writing: Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed at different levels of the organization.
Advanced Competencies:
- Interpersonal skills: Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within department.
- Strong interpersonal and communication skills.
- Written communication: Ability to write well-structured technical reports.
- Resource Utilization: Manages and leads people, technological and financial resources within department.
- People Management: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results.
- Acts Decisively: Makes decisions in a timely manner, makes good decisions based on analysis, wisdom, experience, and judgment.
- Grows others: Provides challenging and stretching tasks and assignments.
- Emotional Intelligence: Identify, assess and control the emotions of oneself and awareness of others.
Responsibilities:
- Responsible for management of Site Quality Review program at site.
- Understand the Quality/ Site objectives - identify the key performance indicators through which the Quality /Site of objectives can be measured.
- Develop strategy for improved compliance against the metrics and maintain systems to measure performance against established targets.
- Facilitate Site Quality Review meeting and ensure all key metric presented to the management & actions indicated are addressed and successfully implemented.
- Responsible for overview of CAPA management at site.
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.
- Facilitate CAPA Site Quality Review meeting and ensure the actions indicated are addressed and successfully implemented.
- Liaise with Digital and global teams for new modules/ platforms deployment and enhancement /upgrades in gQTS/ eQMS systems.
- Represent as Subject Matter Expert for gQTS/eQMS and management of end users and access roles.
- Support to resolve day-to-day queries and take-up system enhancements to the global team to fix issues.
- Ensure compliance & on-time implementation of corrective actions/preventive actions derived from Regulatory Inspections and Third party or Corporate Assessments through completion.
- Perform Network sites regulatory observations gap assessment or Regulatory Observations Network Assessments (RONA) to identify gaps at site and implement CAPAs within agreed timelines.
- Co-ordinate with Pfizer global Inspection Readiness and global Subject Matter Experts for Inspection Readiness activities.
- Oversee he Inspection Readiness tracker and its timely update as per current information.
- Design & execute awareness trainings, campaigns, and GEMBA walkthroughs to prepare Subject Matter Experts & colleagues confidently engage with auditors or inspectors.
- Responsible for maintaining Inspection Logistics & preparing, running front room & back room during inspection.
- Responsible to drive Quality Culture Maturity Assessment (QCMA) and timely update of Quality Improvement Plan (QIP).
- Review data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status.
**Experience: **Minimum 10 years of experience in the pharmaceutical industry, preferably in sterile formulations
**Preferred Education/ Qualification: **Master’s degree in sciences/ Pharmaceutical sciences
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