Job Description
Job title:
Global Technical Manager APRQ
Job description:
A leading global life sciences company is looking for experienced and talented candidates for the position of Technical Manager Global APQR based in South East Asia including Malaysia.
Conducts annual single-site and E2E reviews to deliver site and E2E APQR reports per requirements in GSP037.
Supports the compilation of APQR reports via the acquisition, visualization, and analysis of data from sites across the network.
Contributes to the performance metrics and overall Quality assessment and reporting as part of the APQR business process.
Responsible for executing records in the Quality Management System (including Global Change Control ownership, Discrepancy Investigations, CAPA, etc.).
Works with APQR stakeholders to identify, escalate, and resolve product quality issues.
Proposes actions items based on APQR conclusions, as needed.
Provides training and guidance to APQR stakeholders as needed regarding the Global APQR process, including planning and implementation of procedures.
Supports the development, maintenance, and execution of Global APQR systems, projects, and administrative activities.
Requirements:
B.A., B.S. or Higher degree (preferably in Life Science)
Minimum 5 years of applicable cGMP pharmaceutical or biopharmaceutical or related industry with experience in technical writing.
Technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as associated control and documentation systems (e.g., MELODI, SAP, ValDam, Veeva).
Knowledge of quality requirements for medical devices and device combination products is a plus. Experience collaborating in a global setting to support product teams and global quality initiatives.
Experience in routine (business and/or compliance) metrics reporting processes.
CEI: R2090154 | Licence No.: 22S1313
