Senior Quality Assurance Officer
2 weeks ago
Kenton Black Science & Engineering is seeking an experienced Senior Quality Assurance Officer to join their team. This role is ideal for a detail-oriented individual with a strong background in quality assurance and a passion for ensuring compliance with regulatory guidelines.
Key Responsibilities:
- Develop, maintain, and improve quality management system (QMS) documentation.
- Conduct thorough investigations into quality issues and perform root cause analysis to prevent reoccurrence.
- Ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards and stay up-to-date with the latest regulatory guidelines and requirements.
- Manage internal audits to guarantee continuous compliance and readiness for external inspections.
- Work closely with the Regulatory Affairs department to support regulatory submissions and responses to regulatory authorities.
- Provide guidance and support for validation activities, ensuring that all systems are qualified and processes are validated.
- Lead project management and execution for quality assurance-related initiatives.
Requirements:
- Bachelor's degree in a scientific discipline.
- A minimum of 3 years of experience within a GMP quality assurance department.
- In-depth knowledge of QMS documentation and experience in conducting investigations and root cause analysis.
- Sound understanding of Regulatory Affairs, as well as GMP and GDP compliance guidelines.
- Excellent project management and execution skills, with the ability to work independently and as part of a team.
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