QA Internal Auditor - Visakhapatnam/Vizag @ Pfizer

Perform and control the full audit cycle and compliance with all applicable regulations and site/corporate procedure

Internal Audits (System based Audits and Walkthroughs):

• Create annual audit summary reports and perform risk assessment activities for preparation of the following year audit schedule
• Generate audit schedule, plan audit, write report, communicate audit findings to auditee and management,
• Conduct opening and closing meeting for quality systembased audits. Lead audit team as required.
• Responsible for review, approval and implementation and verification of Corrective Action and Preventive Action.
• Conduct walkthrough audits and quality system audits
• Ensure recommendations are presented to the Site Quality Review Team (SQRT).

Inspection Management:

• Ensure policies and procedures are developed, maintained in accordance with Corporate and regulatory requirements as they relate to GMP and GLP
• Ensure Internal quality audit and Regulatory commitments are closed out in accordance with agreed timelines and appropriately address the deficiencies.
• Participate in inspections and other second and third-party audits, as appropriate
• Coordinate the Inspection Readiness program and participate in regulatory and corporate audits as Front room/ Back room personnel as required.
• Perform Regulatory observations network assessments to identify gaps at site and implement CAPA within agreed timelines.
• Prepare and report on Key Performance Indices and departmental activities in monthly management reports, SQRT meetings and BSC.
• Ensure compliance with government regulations in relation to quality and safety (e.g. 21 CFR, EU GMP and PIC/S Code of GMP).
• In conjunction with the Internal Audit team manager, support the site implementation of Pfizer Quality Standards (PQS) and gaps are closed within the set time frames and communicated to S-QRT.

Core Competencies:

• Quality System Knowledge: Understanding of the US FDA, EU GMP and PIC/S code of GMP regulatory requirements as it relates to implementation of systems.
• GMP Knowledge: Trained and experienced in GMP fundamentals of operating a compliant facility.
• Auditing Experience: Experience in Internal Audits and External Vendor Audits
• Certifications: Attended and qualified Auditor/Lead Auditor Qualification Course (Ex: IRCA-Pharmaceutical Quality Management System
• Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.
• Lead Audit and Inspection readiness efforts for quality risk management.
• Ensure global medical device requirements are reviewed and considered in existing Quality Management System (QMS) processes.
• Develop and maintain Quality Risk Management (QRM) tools and infrastructure to address emerging compliance and organizational needs.
• Manage projects and conduct Quality Control (QC) activities on deliverables ensuring accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.
• Support audits team and cultivate relationship with Pfizer Audit/Inspection teams and recommend the reports that address needs.
• Design and implement local operating plan in collaboration with the Global Cascading Style Sheets Center of Excellence.
• Provide support for Good Manufacturing Practices {also cGMP} operations within the material management disposition and supplier management programs.
• Manage resources to meet organizational goals and manage routine audit status for vendors.
• Communicate relevant inspection and audit trends to respective country stakeholders, drive that applicable actions are taken to address country gaps.
• Independently conduct, participate and lead audits and assessments of contract manufacturers, select raw material suppliers and service providers.
• Participate in or lead complex investigations of product/facility deviations and investigations including root cause analysis, and approval of investigation reports.

Qualifications

Must-Have

• Masters Degree
• 10 years experience
• Demonstrated organizational and projectmanagement skills
• Demonstrated strength in analytical skills and attention to detail
• Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations
• Able to take action on quality and compliance metrics and trends
• Ability to manage multiple complex projects and has business acumen
• Excellent interpersonal effectiveness and written and verbal communication skills

Nice-to-Have

• Experience in quality control and/or quality assurance within the pharmaceutical industry
• Experience in aseptic processes and operational knowledge
• Knowledge of training design and tools, and experience in applying training methodology