We are looking for a part time external/consultant team member for the local QA department to fulfill both roles - Responsible Person for GDP and Qualified Person (QP) for imported products. You will work with the rest of the team to ensure that local Quality System meets all local and international requirements.
Job title: Responsible Person & Qualified Person at UCB Pharma Romania
Reports to: Regional Quality Lead
Responsibilities for RP include:
Ensure that all aspects of the handling and distribution of pharmaceutical products comply with the requirements of the EU Good Manufacturing Practices / Good Distribution Practices and relevant local regulatory and legislative requirements.
Ensure, in collaboration with Quality Leader, the implementation, maintenance and upgrading of the local Quality System in order to drive compliance with local/International GDP regulatory requirements and UCB global standard operating procedures
Provide quality oversight to local GDP vendors particularly such as warehouse/distribution service providers in compliance with UCB Quality Standards (qualification, quality agreements, vendor management).
Responsibilities for QP include:
The QP shall perform the obligations of a Qualified Person as required by applicable law and, in particular, shall systematically ensure that all goods arriving to Romania are handled according to Good Distribution Practice and Good Manufacturing Practice until the goods are received by the customers or such other entity as designated by UCB ROMANIA. For this purpose, the QP shall:
Prepare and maintain a suitable and adequate system of written procedures (SOPs, Protocols, Records) to release or reject UCB batches imported from countries outside the European Economic Area;
Achieve and forward documentation to UCB ROMANIA according to written procedures;
In collaboration with RP for GDP to examine and investigate complaints or possible quality defects about the marketed products if applicable;
The Romanian Qualified Person of UCB performs the relevant checks according to local procedure, releases the product on the Romanian market
What the ideal candidate would look like?
• Minimum of 5 years working in the pharmaceutical industry in a quality management position.
• Responsible person should meet the qualification and all conditions provided for by the local and EU regulation
• Operational GMP/QP experience (. local batch release for products imported from Switzerland to EU market)
• Solid knowledge of relevant legal requirements/applicable regulation of the pharmaceutical industry
• Ability to work with autonomy and handle complex/difficult situations.
• Good interpersonal, verbal, and written communication skills
English: Fluency in English is a must
PC: MS Office (Word, Excel, PowerPoint, Outlook)