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Pfizer
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Group Manager - Manufacturing Compliance & Inspection Readiness

Group Manager - Manufacturing Compliance & Inspection Readiness

Pfizer

10 - 14 years

0 Lacs

andhra pradesh

Posted:2 days ago| Platform: Shine logo

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Skills Required

compliance capa qrm quality assurance relationship management interpersonal skills people management communication skills computer proficiency analytical skills time management continuous improvement regulatory inspections metrics preparation good manufacturing practices cgmp problemsolving skills

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: Every day, everything you do will be driven by an unwavering commitment to delivering safe and effective products to patients. The quality culture at the company is both science and risk-based, designed to be flexible, innovative, and customer-oriented. Your role, whether it involves development, maintenance, compliance, or analysis through research programs, will be crucial and have a direct impact on patients. The dedication to quality and safety ensures that the highest standards are consistently met, making a real difference in the lives of those who rely on the products. Key Responsibilities: - 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 the 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 a periodic basis in relation to CAPA. - Develop strategy for improved compliance against the metrics and maintain systems to measure performance against established targets. Qualifications Required: - Masters 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. Additional Details (if present): Omit as no additional details of the company are mentioned in the provided job description.,

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Pharmaceutical Manufacturing

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Group Manager - Manufacturing Compliance & Inspection Readiness