Key Role: Compliance Specialist
The Compliance Specialist will be part of a small team responsible for quality compliance and training activities within our clinical manufacturing facility. This role involves implementing, monitoring, maintaining, and improving systems and processes used for Quality compliance.
* Implementing, monitoring, maintaining, and improving the systems and processes used for Quality compliance.
* Maintenance and administration of training systems and processes.
* Roll out of global initiatives.
* Supporting colleagues with guidance on documentation, compliance issues and systems support.
* Working proactively to ensure delivery of on-time high quality records, investigations, and associated actions.
* Monitoring metrics and trends to improve compliance standards that meet internal and external auditor expectations.
* Leading quality-based investigations and associated action outcomes.
* Providing review and oversight of documentation associated with change requests, manufacturing, and cleaning to ensure compliance with regulatory agencies and quality standards.
* Developing and continuous improvement of systems that maintain or enhance compliance within the department.
* Leading compliance inspections and audits, metric generation, and trending of data.
* Development and administration of training within the facility.
* Oversight of compliance with Data integrity and ALCOA principles.
* Maintaining regulatory compliance in accordance with current Good Manufacturing Practices and quality standards.
Required Skills & Qualifications
* University graduate in a science related subject (Chemistry/ Biochemistry or equivalent) with 2 years of relevant experience.
* Good attention to detail and good documentation practices.
* Knowledge of current Good Manufacturing Practices and applicable GxP regulations and standards.
* Experience in quality management systems.
* Experience in training management systems.
* Competent in Microsoft Office programs.