Qualified Person

• Assist the QA department in the review, approval and implementation of CAPAs and Change Controls 
• Assist in ensuring that activities carried out at the facility are compliant with EU cGMP standards 
• Provision of Quality Assurance support on specific projects, as required 
• Ensure that the product to be released has been manufactured and tested in compliance with its Marketing Authorization, including the supply of raw materials and packaging materials
• Ensure that the product to be released has been stored and transported as per the required storage conditions
• Ensure that sampling has been carried out in a manner that ensures that the sample is representative of the batch 
• Ensure that a stability program is being implemented and adequately followed at the site of manufacture
• Assist in the investigation of quality defects and market complaints and is involved in the decision on whether a recall is required or not
• Assist in the investigation of OOS/OOT investigations 
• Actively participate in any recall exercise as necessary, including mock recalls 
• Ensure that the necessary technical agreements required are in place before batch release and that requirements laid down in such agreements are respected
• Review and Authorize shipment under quarantine when required, based on a case-by-case basis  
• Assist in the delivery of training to employees within the company to ensure a properly trained workforce
• Actively participate in meetings to ensure that company processes and procedures are in line with applicable EU legislation and any update thereof 
• Stay updated with any updates to EU GMP guidelines and legislation and attend necessary training programs, including, but not limited to those offered through TPM
• Ensure that the final packaging configuration of the product is in line with the provisions of the Marketing Authorization, including registered Artwork
• Communicate any concerns about batch manufacturing, testing, storage and/or transportation with the QA department and Senior Management where applicable.

Requirements:

• Possesses excellent written and spoken communication skills in relevant languages, including English
• Preferably a minimum of 2 years of local experience within a similar role
• Experience in managing and developing Quality Systems.

Education:

• Proven license as a QP
• Bachelors or Masters in Pharmacy.

Benefits:

• Medical Insurance
• Flexible Working Hours.