QMS/CAPA Engineer

Philips

4 - 6 years

6 - 10 Lacs

pune

Posted:2 hours ago| Platform:

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Skills Required

career development performance management technical writing project management pharma healthcare german continuous improvement operations auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Supervises day-to-day operations of the QMS team, ensuring all quality processes are executed efficiently and in compliance with company policies and other necessary requirements.
Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control, training, and internal audits, ensuring they are effective, compliant, and aligned with both regulatory requirements and business needs.
Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics, identifying trends, and developing action plans to address gaps, enhance compliance, and improve overall quality.
Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
Facilitates cross-functional collaboration to resolve quality-related issues, working closely with other departments to ensure alignment and effective problem-solving.
Manages the documentation and resolution of non-conformance reports (NCRs), ensuring systematic tracking, effective resolution, and implementation of preventive measures to avoid recurrence.
Conducts risk assessments and manages risk mitigation activities, identifying potential risks to product quality and QMS integrity, and developing strategies to minimize their impact.
Drives continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to improve overall quality performance and operational efficiency.
Addresses difficult to moderately complex issues or problems, requiring the evaluation of identifiable factors, following established processes and operational policies in selecting methods and techniques for obtaining solutions.
Guides and mentors the QMS team, actively contributing to employee selection, performance management, compensation management, career development, and overseeing operational processes.
Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
Manages CAPAs as CAPA enginee

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