Qualified Person

Key Responsibilities For This Role Include

• Perform QA/QP batch release as required to support operational business requirements (the job holder is required to be named on the site manufacturing licence as a QP and perform QP batch release as per current relevant EU guidelines).
• Provide technical expertise for all QA and compliance topics/issues as required.
• Provide QA input into relevant Risk Management programmes within the company and to utilise risk management tools to support science based decision making in support of the highest product quality, safety and efficacy standards.
• Assist with development and implementation of effective performance monitoring indicators for the Quality Assurance department.
• Perform timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
• Provide support for deviation investigations, including root cause analysis and corrective and preventative action (CAPAs) proposals and initiatives.
• Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Actively contributes to continuous improvement activities.
• Work with cross-site teams as required to implement client global quality policies and compliance improvement initiatives.

The Minimum Qualifications For This Role Are

• Minimum of a Bachelor’s degree in a Science related discipline with a minimum of 5 years’ relevant experience within the Pharma industry or a related field.
• Must be eligible for Qualified Persons status as per EU guidelines.
• Previous experience in a sterile product manufacturing facility is highly desirable.
• Quality system aspects experience including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release is desirable.
• Working management of risk management tools (eg. Hazard Analysis and Critical Control Points and / or Failure Mode Effect Analysis.
• Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills.
• Must possess very good verbal and written communication skills, presentation skills, organizational skills and IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, etc.)
• Self-driven attitude, demonstration of curiosity and innovation to drive project development forward.