Biopharmaceutical Innovation Specialist
2 days ago
Job Overview:
A pivotal role is available for a dedicated professional to drive innovation and excellence in serving patients worldwide. This role demands a can-do approach, leveraging expertise and passion to achieve goals.
Key Responsibilities:- Support quality audits, ensuring seamless integration of quality into all aspects of operations.
- Coordinate data entry into Quality System, incorporating approved audit responses.
- Plan and execute quarterly investigator site audits, identifying resources through risk assessment.
- Develop yearly plans for internal process/Service Provider and Affiliate Audits.
- Update audit tracking tools, distribute allocations to audit teams, and compile reporting metrics.
- Resource planning and coordination for outsourced audits.
- Provide necessary tools, reports/documentation, and system access for outsourced audits.
- Review initial draft audit reports, audit responses, and debrief slides.
- Schedule and facilitate pre-audit meetings and post-audit debrief sessions.
- QC data entry into AMS and confirm data entry into RDCS of approved audit responses.
Requirements:
- Masters degree in Life Sciences or related field.
- Minimum 3-5 years of experience in biopharmaceutical industry in Quality Management, Quality Assurance, or relevant areas.
- Experience supporting regulatory authority inspections, pharmacovigilance activities, and electronic QMS implementation.
- Quality Assurance Qualification/Certification (desired).
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