Senior Quality Assurance Specialist
The Senior Quality Assurance Specialist plays a pivotal role in the team, overseeing the day-to-day management of Quality Operations and Compliance. They ensure seamless manufacturing operations while supporting organizational objectives.
Key Responsibilities
* Represent Quality during manufacturing operations, resolving issues collaboratively.
* Provide operational quality support for production, ensuring compliance with product licenses and filings.
* Perform production AQLs, incoming inspection, and raw material disposition.
* Review manufacturing-related documents in accordance with facility requirements.
* Implement and oversee quality systems, ensuring regulatory compliance and alignment with company policies.
* Provide quality input and oversight of the manufacturing facility, including data integrity.
* Manage supplier qualifications, auditing vendors, and overseeing Quality Technical Agreements.
* Generate quality metrics and prepare presentations for senior management review.
* Approve quality documents and support validation activities.
Requirements
* 4-7 years' experience in finished product pharmaceutical/biologics manufacturing.
* Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs, and ICH guidelines.
* Highly flexible, effective team player with strong communication skills.
* Demonstrated capability to establish collaborative relationships across all levels.
* Strong scientific thought processes and ability to apply strategic thinking.
* Ability to work independently and as part of a dynamic team.
Preferred Qualifications
* Demonstrated expertise in Data Integrity highly desirable.
* Working experience in SAP and LIMS highly desirable.
* Regulatory audit experience (HPRA or FDA) desirable.
Education and Licenses
* BSc in science discipline required.
* Lead auditor certification highly desirable.
* Qualified Person experience or educational requirements desirable.