Qualified Person - QP (Hybrid)

Our client, a reputable pharmaceutical company, is looking for a Qualified Person - QP. Your responsibilities would include: 

• Ensuring that a quality management system is maintained
• Ensuring that any additional requirements imposed on certain products by national law are adhered to
• Managing the day-to-day operations of the Quality department in liaison with the QA/RA Manager
• Overseeing the Quality activities pertaining to the company's status as an MA holder
• Upkeeping and maintaining of technical agreements
• Liaising with Malta Medicines Authority as necessary in liaison with the QA/RA Manager
• Reviewing the site master plan, site master file and policies
• Preparing and managing of the annual internal audit schedule
• Generating and reviewing the compilation of a periodical Product Quality Review
• Generating and reviewing Standard Operating Procedures, Corporate Policy Statements, and other defined critical documentation
• Representing the company during audits for clients, certifications, or whenever necessary
• Performing Quality audits, both self-inspection and of distributors and third-party bulk and finished dosage form manufacturing sites
• Generating and keeping updated training material
• Providing and receiving training sessions on GMP/ GDP/ Quality topics are carried out for company personnel
• Compiling and reviewing of all change requests, customer complaints investigations, and CAPA
• Coordinating of return/s and recall/s with QA/RA Manager
• Ensuring that suppliers and customers are approved
• Compiling and reviewing of manufacturer’s change requests
• Overviewing the Serialisation process and approve change controls

• Possesses excellent written and spoken communication skills in relevant languages, including English
• Multitasking and organisation skills
• Analysing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution

• Qualified to act as Qualified Person (QP)
• Tertiary degree level of education in a related field
• Preferably a minimum of 2 years local experience within a similar role
• Experience in managing and developing Quality Systems