Purpose
An exciting opportunity has arisen for a Quality Assurance Specialist to join our team. The role ensures that the QA team objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations.
This position will report directly to the Quality Assurance COE Lead.
Requirements
* Support various site functional and cross-functional tier structures.
* Completes review and approval for CAPAs, change requests, investigative protocols, and final reports.
* Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, and supplier management system upkeep.
* Involved in the development and review of documentation and quality records in collaboration with other stakeholders such as QC, MS&T, Engineering, and Warehouse throughout the product lifecycle e.g., method validation, facility upgrades, qualification protocols, calibration records.
* Review and approve GMP documentation/data for accuracy and completeness.
* Working cross-functionally to ensure project milestones are met in a timely manner.
* Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
* A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
* Strong collaboration and cross-functional leadership skills.
* Strong verbal and written communication skills, project management skills.
Requirements
* Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
* 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
* 2 years of experience in performing the release function in a regulated environment
* Strong knowledge of qualification and implementation of single-use technologies and raw materials for use in a GMP environment.
* Strong contemporary knowledge of relevant cGMPs, regulations, and current industry trends.
* Proven track record in delivering excellence.
* Knowledge of SAP, KNEAT, and Veeva systems is an advantage.