QA Qualified Person

Main Purpose and Objectives of Position:

As a member of QA and QP team, this position is responsible for:

• Delegate Qualified Person tasks listed below
• Assume PR&D QA tasks as listed below
• Ensure compliance with EU and Belgian regulatory requirements, GMP/GDP and client standards of activities performed on behalf of the client.
• Working with the CPSD and PR&D functions as well as key members of the Global Quality Development Unit, Business Partners, CPs and Regulatory Affairs.
• Contributing to the realization of the Quality Objectives in connection with the GMP’s activities of PR&D.
• Supporting activities performed by QA and PR&D QA groups
• Perform the Final China release, as applicable depending on seniority (Min 5 years of practical experience in Drug R&D or Drug Production and Quality Management with min 1 year in Drug Quality Management)

Key Responsibilities:

• Delegate Qualified Person
• EP (Extemporaneous Preparations) batch release;

Delegate Qualified Person (QP), performing following actions (but not limited to):

• QP certification for FING material received at EU Hub
• Owner, assessor, investigator and/or approver of deviations and change controls;
• Ensure Clinical Trial material is compliant with EU and Belgian regulatory requirements and GMPs, product specification file, the CM&C information approved by the Authorities of the relevant countries;
• Approval of extension of retest date;
• Approval of study/country addition
• Approval of QP release certificate of labelled marketed product;
• Participate in the regular review of global and local quality metrics for GMP/GDP activities including deviation;
• Inform QP and Management of all quality events that could impact SISPQ
• Perform QP oversight on activities linked to the responsibilities of the ELECTS QP
• Lead and participate in different actions and projects impacting ELECTS QA and QP
• EU GMP equivalency confirmation issuance;
• Approval of QP Declaration;
• As a Delegate Qualified Person, perform backup tasks:
• Approval of complaints and deviations
• Approval of QP declaration
• Approval of redistribution
• PR&D QA functions
• Interact with all the quality organizations (GQAAC, QA, Corporate, Regulatory);
• Participate in Regulatory inspections;
• Take part of external audits of Collaboration Partners and Alliance Partners;
• Assist or act as an auditor for Self Inspection;
• Participate in the audit readiness;
• Ensure on time notification of critical quality and regulatory issues to management and asses any relevant communication to authorities;
• Ensure that CAPA are in place, are followed and efficient.
• Ensure adequate management of Retention and Reference samples at EU Packaging Collaboration Partners and Eumedica;
• Assist in products retrieval coordination;
• Provide support for collaborations and alliances with external partners, as well as for Expanded Access Programs.
• Final China Release
• Perform the final Release for China according to art. 9 of China regulations prior to site distribution in China, as applicable.
• Health, Safety and Environment
• Carry out the activities in accordance with company and site safety and environmental requirements.
• Confidentiality
• Ensure that confidential information remains confidential.
• Quality Culture
• 1. Make quality culture the foundation of your work, to ensure our products are safe and effective to im-prove patients’ lives.
• 2. Maintain ownership and emphasis on quality, ensuring quality in all daily activities.
• 3. Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicate appropriately.

Educational Requirements:

Scientific Master’s Degree in Pharmacy, Qualified Person

Experience Requirements:

Minimum 1 years in pharmaceutical environment

Experience requirements for China release (not mandatory for EU QP)

Language Requirements:

Must speak and write fluent English

Additional Information/Requirements:

Experience in production, and ideally in ATMP manufacturing, is a real asset.