Company
pharmaceutical
GroupManager-Inspectionreadiness
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Group Manager-Inspection readiness. Skills: Quality System Knowledge, Good Manufacturing Practices, Good Laboratory Practices, GMP Knowledge, People Management, Problem Solving, Technical Writing, Interpersonal skills, communication skills, Written communication, Resource Utilization, Acts Decisively, Grows others, Emotional Intelligence, management of Site Quality Review program, CAPA management, gQTS/eQMS systems, Inspection Readiness, Regulatory Inspections, Quality Culture Maturity Assessmen”
What You'll Achieve.
key performance indicators through which the Quality /Site of objectives can be measured; improved compliance against the metrics; maintain systems to measure performance against established targets; ensure all key metric presented to the management & actions indicated are addressed and successfully implemented; ensure on time closure of CAPA and drive the metrics; provide feedback to management on periodic basis in relation to CAPA; ensure the actions indicated are addressed and successfully implemented; Support to resolve day-to-day queries; Ensure compliance & on-time implementation of corrective actions/preventive actions; implement CAPAs within agreed timelines; timely update of Quality Improvement Plan (QIP)
Industry & Context.
Problem Solving; Ability to investigate, identify root cause and preventative measures using appropriate tools
management/handling of regulatory agency inspections, regulatory agency inspections, Regulatory Inspections, Third party or Corporate Assessments, Network sites regulatory observations gap assessment, Regulatory Observations Network Assessments (RONA), Inspection Readiness, auditors or inspectors, Inspection Logistics, front room & back room during inspection, Quality Culture Maturity Assessment (QCMA)
What They're Looking For.
Must Have
Minimum 10 years of experience in the pharmaceutical industry, preferably in sterile formulations
Nice to Have
Master’s degree in sciences/ Pharmaceutical sciences
What You'll Do.
management of Site Quality Review program at site
Develop strategy for improved compliance against the metrics
Facilitate Site Quality Review meeting
overview of CAPA management at site
Monitor the CAPA Life Cycle
Track/ Trend CAPA metrics
Facilitate CAPA Site Quality Review meeting
Liaise with Digital and global teams for new modules/ platforms deployment and enhancement /upgrades in gQTS/ eQMS systems
Support to resolve day-to-day queries
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)
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
Design & execute awareness trainings
and GEMBA walkthroughs
Responsible for maintaining Inspection Logistics & preparing
running front room & back room during inspection
drive Quality Culture Maturity Assessment (QCMA)
Review data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status
How You'll Work.
Team & Collaboration
cross-functional coordination; Liaise with Digital and global teams; Co-ordinate with Pfizer global Inspection Readiness and global Subject Matter Experts
Communication Scope
interpersonal and communication skills; Written communication; Ability to write well-structured technical reports; Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed at different levels of the organization
Process & Methodology
management/handling of regulatory agency inspections, Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within department, Clearly assigns responsibility for tasks and sets clear objectives and monitors process, progress, and results
Full 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 p
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