Group Manager-Inspection readiness

Job Description

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