Group Manager-Inspection readiness

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