A Quality Assurance specialist is required to perform quality activities at Contract Manufacturing organizations (CMs). The role involves ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
The key responsibilities of this role include:
* Providing quality oversight of CMs including being the initial point of contact for all quality-related issues.
* Escalating quality issues at CMs to QA management.
* Assisting in the establishment and revisions of Quality Agreements with affiliates and customers.
* Ensuring compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
* Coordinating and performing QA responsibilities of API shipments.
* Participating in regulatory inspection preparations with CMs and providing on-site support during inspections.
* Ensuring that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
* Providing quality support of API manufacturing with a focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
This role requires a thorough technical understanding of quality systems and regulatory requirements. Ideal candidates will possess experience working with external manufacturers and large molecule / Bio production.