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Corrections & Removals Specialist

Corrections & Removals Specialist

Philips

4 - 9 years

6 - 11 Lacs

pune

Posted:1 day ago| Platform:

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Skills Required

rca root cause analysis data analysis supply chain management manager quality assurance pharma clinical research healthcare manager quality control technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Coordinates the creation and completion of correction and removal (C&R) file documentation and ensures comprehensive C&R file preparation and timely responses to correction and removal requirements.
Evaluates corrections and removals (C&R) activities and provides timely and ongoing information as necessary for informed decision-making and effective management of product-related issues and improvements.
Monitors and reports on key performance indicators (KPIs) related to corrections and removals, ensures accurate tracking of metrics, and facilitates the generation of periodic reports for comprehensive analysis and evaluation.
Reviews and submits relevant communication to the appropriate competent authorities or regulatory agencies, as per the regulatory requirements of the respective country or market, and conveys vital information related to product safety concerns and risk mitigation strategies.
Executes product recalls and field actions, ensures efficient communication and collaboration between internal teams and external stakeholders, addresses safety concerns and regulatory requirements and minimizes impact on customers with relevant protocols and procedures.
Supports audits and inspections related to Correction & Removal requests by preparing documentation, coordinating with regulatory bodies, and ensuring compliance with applicable regulations and standards.
Implements corrective actions, executes necessary improvements, maintains awareness of customer feedback and incorporates insights into corrective action plans to ensure continuous enhancement.
Examines and analyzes product complaints and adverse event reports to determine their validity and potential impact and assesses these issues to recommend appropriate corrective actions to address and resolve them effectively.
Utilizes a working understanding of relevant global regulations, requirements, and standards to proficiently execute correction and removal tasks, ensuring compliance and swift resolution of issues to uphold product safety and regulatory compliance.

Minimum required Education:
Bachelors Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent. Minimum required Experience:
4 years of experience in Pharma, IVD, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent with Vocational Education. Preferred Skills:
Device Recall Procedures Quality Management Systems (QMS) Data Analysis & Interpretation Regulatory Requirements KPI Monitoring and Reporting Technical Documentation Root Cause Analysis (RCA) CAPA Methodologies Regulatory Compliance Recordkeeping Business Acumen

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Philips

Healthcare Technology

Amsterdam

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Corrections & Removals Specialist