PURPOSE

To ensure the company operates within the guidelines of Good Manufacturing Practice (EU-GMP) and Good Distribution Practice (EU-GDP) and that products are manufactured, tested, released and distributed in accordance with the same guidelines.

KEY DUTIES AND RESPONSIBILITIES

Please note, this list is not exhaustive, and responsibilities may include any other reasonable requests in line with your skill set.

• To ensure that processes and procedures are adhered to within the agreed timeframe where requested, or act as the SME (Subject Matter Expert) as appropriate.
• Act as the SME for key areas of the Quality Management System. To be determined based upon experience and skill set.
• Generate the QA department’s KPIs for which they are the named SME, to be presented in the monthly management meeting.
• Create and update procedures, policies and documentation as required to ensure consistent and safe pharmaceutical products as well as acting as an enabler to drive the Quality Management System forwards.
• Participate (as either lead or co-auditor) in self-inspections in accordance with the annual schedule.
• Identify potential quality issues and develop strategies to mitigate risks using appropriate risk management tools.
• Working with key internal and external stakeholders, analyse issues, identify root cause(s) and implement appropriate corrective and preventative actions in cases such as process deviations, complaints, non-conformances and out-of-specifications.
• Advise relevant departments on GMP matters and GMP compliance.
• To liaise with Contract Manufacturing Organisations (CMOs) as appropriate to compile Annual Product Quality Reviews (aPQRs) in line with annual schedule.
• To keep abreast of the regulations of the Medicines and Healthcare Regulatory Agency (MHRA) and additional European regulatory legislation and guidelines as appropriate.
• To keep up to date with the company’s current and future product range and offer GMP consultative support where required for New Product Introduction (NPI) and New Product Launch activities.
• To comply with the office policies and guidelines.
• To carry out any other responsibilities within the Quality department as requested by their Line Manger.