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Location: Gurgaon/Gurugram
Salary: Open
Employment Type: Permanent
Sub-industry: Pharmaceuticals
Function: Business Operations, Healthcare R&D

Company Overview

Our client is an american multinational pharmaceutical corporation and one of the world's largest pharmaceutical companies

Job Description

Designation- Assistant manager/ Deputy manager - Internal auditor

: Perform and control the full audit cycle and compliance with all applicable regulations and site/corporate procedure
Internal Audits (System based Audits and Walkthroughs):
o Create annual audit summary reports and perform risk assessment activities for preparation of the following year audit schedule
o Generate audit schedule, plan audit, write report, communicate audit findings to auditee and management,
o Conduct opening and closing meeting for quality system-based audits. Lead audit team as required.
o Responsible for review, approval and implementation and verification of Corrective Action and Preventive Action.
o Conduct walkthrough audits and quality system - audits
o Ensure recommendations are presented to the Site Quality Review Team (SQRT).
Inspection Management:
o Ensure policies and procedures are developed, maintained in accordance with Corporate and regulatory requirements as they relate to GMP and GLP
o Ensure Internal quality audit and Regulatory commitments are closed out in accordance with agreed timelines and appropriately address the deficiencies.
o Participate in inspections and other second and third-party audits, as appropriate
o Coordinate the Inspection Readiness program and participate in regulatory and corporate audits as Front room/ Back room personnel as required.
o Perform Regulatory observations network assessments to identify gaps at site and implement CAPA within agreed timelines.
o Prepare and report on Key Performance Indices and departmental activities in monthly management reports, SQRT meetings and BSC.
o Ensure compliance with government regulations in relation to quality and safety (e.g. 21 CFR, EU GMP and PIC/S Code of GMP).
o In conjunction with the Internal Audit team manager, support the site implementation of Quality Standards (PQS) and gaps are closed within the set time frames and communicated to S-QRT.
Core Competencies:
o 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.
o GMP Knowledge: Trained and experienced in GMP fundamentals of operating a compliant facility.
o Auditing Experience: Experience in Internal Audits and External Vendor Audits
o 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.
o Lead Audit and Inspection readiness efforts for quality risk management.
o Ensure global medical device requirements are reviewed and considered in existing Quality Management System (QMS) processes.
o Develop and maintain Quality Risk Management (QRM) tools and infrastructure to address emerging compliance and organizational needs.
o Manage projects and conduct Quality Control (QC) activities on deliverables ensuring accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.
o Support audits team and cultivate relationship with Audit/Inspection teams and recommend the reports that address needs.
o Design and implement local operating plan in collaboration with the Global Cascading Style Sheets Center of Excellence.
o Provide support for Good Manufacturing Practices {also cGMP} operations within the material management disposition and supplier management programs.
o Manage resources to meet organizational goals and manage routine audit status for vendors.
o Communicate relevant inspection and audit trends to respective country stakeholders, drive that applicable actions are taken to address country gaps.
o Independently conduct, participate and lead audits and assessments of contract manufacturers, select raw material suppliers and service providers.
o Participate in or lead complex investigations of product/facility deviations and investigations including root cause analysis, and approval of investigation reports.


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

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

Experience required- 9 plus years

Additional Information

Location- Vizag