
Senior Quality Systems Manager
1 week ago
Our organization seeks a Quality Systems Manager to join our team. This is a pivotal role that requires a high level of expertise and leadership.
Job DescriptionThe Quality Systems Manager will be responsible for establishing, implementing, and maintaining quality systems across the API manufacturing unit. This involves leading and participating in regulatory, internal, and third-party audits, ensuring timely closure of observations and CAPAs.
Key responsibilities include reviewing and approving validation protocols, master documents, and batch records in line with regulatory requirements. The Quality Systems Manager will also oversee product release, stability studies, and quality documentation control.
Additionally, this role entails managing and investigating market complaints and implementing appropriate corrective actions. Ensuring regulatory compliance with international guidelines, such as USFDA, EU-GMP, and WHO-GMP, is also a key aspect of this position.
Required Skills & Qualifications- Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field.
- 8-12 years of experience in QA roles within API manufacturing, including managerial experience.
- Strong understanding of GMP, ICH guidelines, and international regulatory frameworks.
- Proven experience with regulatory inspections (USFDA, MHRA, EUGMP, etc.).
- Excellent leadership, documentation, and communication skills.
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