Quality Assurance Professional

Job Elements

• The day-to-day management and implementation of a comprehensive formal Quality Management System (QMS) within the Pharmaceutical Quality System (PQS), as aligned with Good Manufacturing Practice (GMP)
• Resourcing QA tasks, supervising staff within QA and assisting other members of staff throughout the business in conducting work in a compliant manner to ensure customer satisfaction.
• Lead a team of Quality Assurance Analysts, responsible for day-to day scheduling of resources to deliver department responsibilities
• Supervising activities within the QA team to ensure effective operation of the department
• Promote GMP standards to ensure a strong compliance culture
• Review data for technical quality and compliance of protocols, methods and Standard Operating Procedures (SOPs)
• Review and approve QMS records, including change controls, deviations, root cause analysis, laboratory investigations, CAPA and risk assessments
• Ensuring your team’s on-time completion/closure of all assigned QMS records, leading by example in this area
• Maintain QMS spreadsheets to monitor on time completion of QMS activities and allow accessible generation of track & trend metrics
• Ensure that internal audits are carried out to the approved schedule and that observation reports are provided to the responsible Manager according to the Self-Inspection procedure
• Promote systems and processes that ensure data integrity throughout the data lifecycle, including alignment with ALCOA+ and Computerised System Validation (CSV), including data recording of your assigned team
• Administer the document control system, ensuring all new staff have access and appropriate permissions in accordance to relevant SOPs
• Author assigned SOPs and other relevant documents
• Assist Manager with hosting Customer Audits and Regulatory Inspections and lead timely response to any observations received.

The ideal candidate will have:

• Preferably a degree in a science, pharmacy or relevant discipline of grade 2.1 or above
• Extensive proven experience of overseeing system aligned to regulatory requirements e.g. GMP, ICH, COSHH
• Proven team management experience required: strong leadership skills and leading by example at all times
• Relevant scientific/technical experience gained within an appropriate pharmaceutical environment / academic institution
• Expertise around formulation design and development activities, preferably inhalation and associated analytical methods would be advantageous
• Ability to communicate and work with personnel of all levels, internally and externally
• Proven flexibility in adjusting to a rapidly evolving workload and remaining calm under pressure
• Training in auditing regulated quality systems desirable