Investigation and Deviation Expert

Job Summary

The Investigation and Deviation Expert role is designed to collaborate with process experts and multifunctional operations teams in Biologics and/or large molecules platform sites, taking ownership of deviation management for the site.

Responsibilities

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• Manage deviations in 1QEM system for responsible sites using quality management framework.">">
• Conduct root cause analysis according to established procedures and site practices.">
• Use various RCI tools and methodologies such as Fishbone diagram, 5 Whys, and timeline and process mapping where applicable to facilitate root cause analysis.">
• Coordinate with site SPOC and other stakeholders from Production unit, Quality Assurance, Engineering team, and site leadership team.">
• Ensure all stakeholders are informed about progress of investigation, manage necessary communications, and adhere to timelines.">
• Participate and Facilitate Deviation and RCI review meetings, capturing key information and translating it into actionable clear documentation.">
• Track and report on metrics related to change control documentation, including timeliness, compliance, and quality.">
• Develop, revise, and maintain high-quality documentation related to Deviation management processes, ensuring alignment with cGMP and other regulatory standards.">
• Support and contribute to QMS actions such as Change Controls CAPA effectiveness checks EC risk assessments, and OOXs management.">
• Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable.">
• Provide technical scientific expertise to address process-specific matters, ensuring compliance with cGMP SOPs relevant guidelines functional standards, including HSE NOSSCE.">
• Ensure overall inspection readiness for area of responsibility.">
• Support creation and review of GxP documents, including SOPs working procedures trend reports while ensuring compliance with internal quality standards regulatory requirements filed product quality standards service level agreements.">
• Support Health Authority HA audits by ensuring compliance with GxP environment handling procedural requirements, in alignment with Quality Management System QMS standards.">
• Support implementation adhere to all instructions requirements for safe work environmental protection property protection.">
• Comply with internal functional requirements KPI reporting ticket management tools and other internal procedures and processes.">
• Complete tasks determined during annual objectives setting process and by KPIs, as applicable.">
• Assist team with any ad hoc activities requests to meet business requirements.">

Key Performance Indicators:

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• Quality Accuracy Right First Time">
• Timeliness">
• Deviations Escalations">
• Quality System Management Change Control CAPA Risk Assessment and EC Support">

Professional Competencies:

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• cGMP and Good Documentation Practices">
• Deviation Handing">
• Root Cause Analysis RCA">
• Corrective Action and Preventive Action">
• Change Control Management">
• Knowledgeable on Effectiveness Checks">
• Continuous Process Improvement">
• Drug Substance Manufacturing">
• Process Design and Control">
• Gap Assessment and Risk Analysis">
• Complaints and OOXs Handling">
• Technology">

Requirements

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• Deep understanding of cGMP and quality management principles.">
• Strong analytical and problem-solving skills.">
• Excellent communication and interpersonal skills.">
• Ability to work effectively in a team environment.">
• Proficient in MS Office and data analysis software.">
• Detail-oriented with strong organizational skills.">
• Self-motivated with ability to work independently.">

Working Conditions

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• Full-time position.">
• Normal working hours.">
• Standard office equipment and software.">
• Opportunity for professional growth and development.">

What We Offer

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• Competitive salary and benefits package.">
• Generous paid time off.">
• Opportunities for career advancement.">
• Collaborative and dynamic work environment.">

How to Apply

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2. Review job description and requirements carefully.">
3. Submit your application with a cover letter and resume.">
4. Wait for response from our hiring team.">