QA Specialist

Our client, a leading Pharmaceutical company operating in Malta, is recruiting for a QA Specialist to join their QA Team and support the Manager by acting as a deputy. In this role, your duties will include;

• To manage the SOP system including change requests and deviations as per SOP
• To prepare and manage Annual Product Reviews as well as qualifications of materials and suppliers according to SOP in force
• To update any expired material and transfer it to QC status on the ERP system whenever requested by the warehouse leader,
• To review production batch records before approval: ensuring that all the critical parameters are performed correctly
• To ensure that deviations related to that process have been pointed out and investigated; ensure that the batch record is filled in accordance to GMP requirements.
• To review cleaning batch records as well as check and sign batch records before they are issued to production personnel
• To prepare the annual training plan in respect to procedures and update all employees’ training documents: training forms, GMP training records and training evidence
• To provide induction GMP training and any other specific training to every new employee and existing employees when necessary (such as training on specific SOPs)
• To assist the QA Manager and to provide the necessary documents during customer and/or authorities’ audit
• To carry out internal audits in specific areas under the surveillance of the QA Manager
• To prepare labels for finished goods, to be sent to clients, according to shipping documents and according to the approved SOP
• To prepare the relative certificates of analysis

• Previous experience within QA is required
• Sound knowledge and experience in the processes of Change Controls and Deviations
• Good knowledge of GMP Standards
• Excellent communication skills in English (written and verbal)
• Able to prioritize daily duties as necessary, take ownership of assigned duties and collaborate well within the team
• Based in Malta

• A Bachelors degree in Science/Pharma or a relative degree is a must