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Investigation Specialist
2 weeks ago
A highly skilled and detail-oriented professional is needed to join our team as an Investigation Specialist. This key role will focus on managing deviations in the quality management framework, working closely with cross-functional teams to drive process improvements.
About the Role:
As an Investigation Specialist, you will be responsible for conducting root cause analyses, coordinating with stakeholders, and ensuring timely communication. You will also participate in deviation and RCI review meetings, capturing key information and translating it into actionable documentation.
Key Responsibilities:
- Conduct thorough root cause analyses according to established procedures and site practices.
- Coordinate with site SPOC and other stakeholders from Production unit, Quality Assurance, Engineering team, and site leadership team.
- Ensure all stakeholders are informed about investigation progress, manage necessary communications, and adhere to timelines.
- Participate and facilitate deviation and RCI review meetings, capturing key information and translating it into actionable 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 regulatory standards.
- Support quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management.
- Provide technical and scientific expertise to address process-specific matters, ensuring compliance with regulatory requirements and functional standards.
- Ensure overall inspection readiness for area of responsibility.
- Support creation and review of Gx P documents, including SOPs, working procedures, and trend reports, while ensuring compliance with internal quality standards and regulatory requirements.
- Support Health Authority (HA) audits by ensuring compliance with Gx P environment and handling procedural requirements.
Requirements:
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a team.
- Proficiency in quality management systems and regulatory requirements.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for career growth and development.
- Collaborative and dynamic work environment.
Join Our Team:
If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply for this exciting opportunity.
