Head of Quality Assurance Expert
1 week ago
This position entails overseeing the entire quality assurance operation within our organization, ensuring adherence to established standards and regulatory requirements. Key responsibilities include:
- Developing and implementing processes for auditing, inspecting, and validating systems.
- Leading investigations into non-conformities and implementing corrective actions.
- Maintaining documentation, records, and reports in compliance with regulations.
- Coordinating vendor qualification activities and maintaining GMP-compliant document control systems.
- Providing guidance on product development projects and programs.
- Ensuring data integrity through audits, training, and review.
- Overseeing validation activities and maintaining ICH Q8, Q9, and Q10 compliance.
- Staying abreast of regulatory changes and advising management accordingly.
- Supporting technology transfer and facilitating necessary documentation and record-keeping.
- Enhancing operational performance to meet regulatory, SOP, and customer demands.
- Reviewing and approving departmental SOPs and ensuring fit-for-purpose operationally and commercially.
- Facilitating self-inspection programs and reviewing batch manufacturing records.
The ideal candidate will possess a strong background in quality assurance, excellent leadership skills, and proficiency in GMP guidelines. Additionally, they must be well-versed in software applications and have effective communication skills.
Competitive compensation packages are available to attract top talent.
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