PURPOSE OF POSITION
To be an integral part of the QA team and to provide general QA support functions. To ensure the integrity of production processes and equipment, facilities, utilities and systems are maintained. Ensuring that the manufacture of GMP Intermediates or API is done as defined by the Quality Management System.
ROLES & RESPONSIBILITIES
- To be the specific lead for assigned QA systems (e.g. SOPs, Audits, Periodic Reviews, Vendor Management, QTAs, Change Control, Deviations, CAPAs, Archiving, Review of Batch Documents and OOS) ensuring that they are maintained in an audit ready situation and that management is aware of any issues.
- To be an integral member of the QA team providing coverage for other team members and their systems as required in routine QA tasks.
- To represent QA on assigned project teams, and with assigned clients to be the main QA contact. Dealing with all associated client and project lead requirements, audits and documentation. Ensuring that during periods of absence the status of all actions is transparent and that effective handover is undertaken.
- To contribute to the Quality Management System Indicators (QMSI) from the compilation, dissemination and the driving of a quality culture throughout the Company.
- To maintain an awareness of changes to UK, European and US pharmaceutical legislation as it relates to their area of specialization.
- To maintain an awareness of changes to UK, European and US pharmaceutical legislation as it relates to their area of specialization
- To assist the Interim Principal QA Advisor in Quality-related projects as delegated
- To uphold the highest quality standards and drive a quality culture throughout the Company
- To ensure all Quality Matters are handled with integrity and completed to agreed timelines
- Scientific qualification and/or relevant pharmaceutical industry experience
- Relevant Quality Assurance experience in a broad range of Quality Systems
- At least 3 years' experience in a Quality Role within a range of Quality Systems
- Project management and coordination across different functional areas
- Quality assurance auditing experience
- Regulatory environment for the pharmaceutical industry
- Ability to interpret and translate GMP guidelines into effective strategies and processes
- Computer literacy in Microsoft Office software (Excel, Word, PowerPoint)
- Excellent communication skills - both written and verbal
- Strong interpersonal skills combined with effective skills of persuasion and negotiation
- Strong networker able to initiate and maintain working relationships across functions, affiliated organizations and third parties
- Pleasant disposition with strength of character
- Proactive, diplomatic, self-motivating, professional with excellent problem solving and decision making capabilities
- Be seen as a good coach and mentor, willing and prepared to share knowledge and coach colleagues
- Strong scientific and technical judgement
Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.