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Pfizer
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Group Manager - Compliance & Investigations

Group Manager - Compliance & Investigations

Pfizer

10 - 14 years

0 Lacs

andhra pradesh

Posted:4 days ago| Platform: Shine logo

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Skills Required

compliance management investigation management assessments walkthroughs process improvement reporting metrics stakeholder management interpersonal skills situational leadership conflict management audits eams enterprise asset management system maintenance oversight projects culture compliance technical knowledge

Work Mode

On-site

Job Type

Full Time

Job Description

The Engineering Compliance & Investigation Manager plays a crucial role in ensuring alignment with cGMP, cGEP, and regulatory standards in partnership with the Engineering Lead. Your responsibilities include leading internal audits, driving a quality culture, overseeing engineering quality metrics, and providing direction for maintenance processes using EAMS. It is essential to ensure compliance, training, and robust documentation, while demonstrating strong leadership in coaching, mentoring, and cross-functional collaboration to sustain and elevate engineering compliance. You will be responsible for compliance management, which involves ensuring adherence to quality systems, safety protocols, and regulatory guidelines. This includes reviewing and approving change controls, documents, and procedures, supporting root cause analysis, CAPA implementation, and timely closure of quality records, ensuring readiness for audits, and implementing Pfizer Quality Standards (PQS) while ensuring training completion. In terms of investigation management, you will lead structured investigations, equipment failures, and non-conformances, ensuring root cause identification and alignment with cGMP and regulatory expectations. This involves applying structured problem-solving methodologies such as 5 Whys, Fishbone (Ishikawa) diagrams, Pareto analysis, and FMEA to drive data-based decision-making and eliminate recurring issues. You will also be monitoring and trending deviation data to identify systemic issues, recurring failure modes, and compliance risks, leveraging dashboards and quality metrics to prioritize focus areas and translating investigation insights into actionable improvement projects. Additionally, you will lead audits, assessments, and walkthroughs to ensure compliance with cGMP, GDP, GEP, and safety systems. This includes identifying gaps, driving corrective actions, ensuring regulatory alignment, and developing subject matter experts through coaching. Furthermore, you will define functional requirements and manage user setup, planning, spare parts, and lead EAMS projects, reviews, and upgrades. It is crucial to ensure data accuracy, monitor system performance, and resolve issues with vendors. Your role will also involve overseeing maintenance processes to ensure the timely completion of planned work orders and monitoring execution to identify and mitigate compliance risks. You will be expected to drive continuous improvement initiatives and oversee their implementation to improve quality excellence, prepare and review MIS reports, compile site quality metrics, trend failures/breakdowns, and recommend corrective actions. Upholding Pfizer Values and complying with statutory obligations while promoting health, safety, and environmental standards is also essential. As a qualified candidate, you should be a technical graduate with over 10 years of experience in the pharmaceutical industry, possessing strong knowledge of audits, compliance systems, and engineering processes. You should be capable of developing and managing team performance through regular feedback and growth plans while fostering a culture of ownership, collaboration, and continuous improvement. In this role, organizational skills, multitasking abilities, effective communication, stakeholder management, interpersonal skills, situational leadership, and conflict management are key requirements. The work location for this position is on-premise. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.,

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Group Manager - Compliance & Investigations