Group Manager-Inspection readiness
- India - Vizag
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