REF 1517638
29.04.2024 | Abu Dhabi | full time
- General
- Location: Abu Dhabi
- Occupancy: full time
- Description
- The Associate, Quality Assurance (QA) will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Warehouse/Materials, Manufacturing, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of QC Operations, Facilities/Engineering, Plasmid Manufacturing Operations, and the review/audit of data and reports as specified by Standard Operating Procedures.
Responsibilities
Perform review and approval of clinical production batch records.
Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments.
Facilitate risk assessment, cross functional team discussions in support of major/critical deviation investigations and change controls as they relate to Quality Control, Facilities/Engineering, and warehouse/Supply Chain.
Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP’s, material specifications, validation protocols, and reports.
Inspect and release GMP raw materials and components against approved specifications.
Provide hands-on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
Assist in the preparation and hosting of regulatory (e.g., FDA, EMA, DHHS, etc.) inspections, as necessary.
Identify gaps or system enhancements and shepherd to completion, as required.
- Requirements
- Experience: at least 1 year
- Provisions
- Salary: to be discussed
- Employment visa provided
- Medical insurance
- Accommodation
- Publisher
- direct employer
- up to 50 employees