Senior Quality Assurance Advisor

at  Pharmaron

Key roles and responsibilities:

• To input/ propose/ modify departmental SOPs/ SPTs.
• To conduct internal Audits and to assist and support external audits by clients and regulatory authorities.
• Perform periodic reviews of Quality Systems including the generation of metrics.
• To support the Vendor Management process, performing Vendor Qualifications, Vendor Audits and Vendor Reviews
• Investigate Deviations, Quality issues and trends and contribute to continuous improvement.
• Provides QA support on change controls and OOS.
• Follow up on CAPAs to ensure timely completion of actions and ensure status visibility.
• Write Quality Technical agreements with appropriate guidance and support.
• Support Qualification / Validation activities.
• Release materials for the production of GMP product
• Review and approve Batch records.
• Provide Quality representation and input at project and planning meetings.
• Review and approve stability protocols and reports.
• Review trend reports for Purified Water, Environmental Monitoring.
• Perform Quality Risk Assessments

Pharmaron acquired the Hoddesdon campus, consisting of several purpose built scientific and administrative buildings together with a purpose built conference area in February 2017. The research building has more than 5,000m2 of premier R&D space and houses an established Process Chemistry, Analytical Chemistry and Drug Discovery teams. In addition, a Formulation Development team was also recently established. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), Formulation Development (FD) and Process Chemistry (PC).

• We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
• We offer state of the art working environment on site.
• We offer the opportunity for growth and development and will support funding for relevant training and development programmes