Job Description:
The Compliance Specialist will play a pivotal role in supporting the Quality Control organization in achieving compliance objectives through laboratory investigation and deviation management. This position involves coordinating and managing preparation for regulatory inspections and internal audits, ensuring QC is audit-ready at all times.
Key Responsibilities:
* Coordinate and manage preparation for regulatory inspections and internal audits to ensure seamless compliance
* Serve as the primary QC point of contact during inspections or audits, addressing inquiries and providing documentation as required
* Organize and maintain QC quality records, including Change Controls, CAPAs, and Workflows, to facilitate efficient compliance tracking
* Lead cross-functional teams during Change Control or CAPA events, ensuring alignment on strategies and resolution plans to drive effective decision-making
* Review, edit, and revise controlled documents to guarantee compliance with written procedures and regulatory standards
* Monitor open compliance records, such as CAPAs, Change Controls, and Workflows, to ensure timely resolution and closure, thereby minimizing risks and optimizing compliance outcomes
* Report quality system metrics to QC teams and other relevant departments to track performance and identify areas for improvement, enabling data-driven decisions
* Represent QC in interdepartmental teams and meetings, ensuring QC perspectives and requirements are considered to foster a culture of collaboration and transparency
Requirements:
* Bachelor's degree in Life Sciences or an equivalent field
* Minimum 2 years of relevant experience, preferably in the pharmaceutical or biotechnology industries