Group Manager – Manufacturing Compliance - Vizag

Group Manager – Manufacturing Compliance for Vizag location.

Below is the detailed job description:

Job Description

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products.

What You Will Achieve

In this role, you will:

• Ensure compliance & on-time implementation of corrective actions/preventive actions derived from Regulatory Inspections and Third party or Corporate Assessments through completion.
• Perform Regulatory Observations Network Assessments (RONA) to identify gaps at site and implement CAPAs within agreed timelines.
• Co-ordinate with Pfizer site Inspection Readiness and global Subject Matter Experts for Inspection Readiness activities.
• Maintain the Inspection Readiness tracker and its timely update as per current information.
• Preparation of the manufacturing IR Meeting slide deck to present in site meetings and leadership meetings
• Responsible for coordinating governance meetings and notify any delays on time to management.
• Provide data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status.
• Lead the upstream compliance team to manage day to day support for manufacturing that includes CCF, CAPA, QRM and training etc.
• Responsible to provide guidance and conduct QRM
• 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.
• Develop strategy for improved compliance against the metrics and maintain systems to measure performance against established targets.

Here Is What You Need (Minimum Requirements)

• Master’s degree in sciences/ Pharmaceutical sciences with at least 10 years of experience
• Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry
• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
• Strong collaboration, relationship management, and interpersonal skills
• Strong people management experience
• Excellent written and oral communication skills
• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent

Bonus Points If You Have (Preferred Requirements)

• Strong analytical and problem-solving skills
• Ability to work independently and make decisions
• Excellent organizational and time management skills
• Experience in interfacing with regulatory agencies during audits

Ability to drive continuous improvement initiatives