Senior QA Expert

Job Description:

We are seeking a seasoned Quality Assurance Specialist to join our team. The successful candidate will oversee and elevate the quality standards of external manufacturing networks, ensuring compliance with GMP, GDP, and ICH guidelines.

The ideal candidate will have expertise in product stewardship, quality systems oversight, technical documentation, validation and qualification, audits and compliance. Proficiency in SAP and Microsoft Office Suite is required. Strong analytical skills and ability to work under pressure are also essential.

Key Responsibilities:

• Product Stewardship: Manage lifecycle changes for assigned molecules and finished dosage forms


• Quality Systems Oversight: Track core QMS processes including deviations Corrective Actions Out of Specification investigations Change Control management


• Technical Documentation: Author evaluate approve critical documents such as Master Batch R...