Company:
Planet Pharma
Location: Novato
Closing Date: 28/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
- Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities
- Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
- Interface with other departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Other duties as assigned
Requirements:
- BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
- Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes
- Excellent written, verbal, analytical, and interpersonal skills
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Planet Pharma