We are looking for a part time external/consultant team member for the local QA department to fulfill role of Responsible Person for GDP. 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
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 Company's global standard operating procedures
- Provide quality oversight to local GDP vendors particularly such as warehouse/distribution service providers in compliance with Company's Quality Standards (qualification, quality agreements, vendor management).
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
• 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)