Quality Assurance Lead

YOUR ROLE

As an integral member of the QA team, enable the delivery a safe quality aseptic manufacturing service to meet cGMP requirements and the needs of the business. The role holder will be expected to provide advice on all aspects of cGMP to support the quality, efficacy and safety of all products manufactured.
To assist the Quality Assurance Manager with the daily operation and development of the Pharmaceutical Quality System (PQS), contributing to the Quality oversight of all operations and the effectiveness and efficiency of the Quality Team.

YOUR DUTIES & RESPONSIBILITIES

• Ensure that there is a robust governance infrastructure over the ePQS, including configuration, access permission, audit trails and secure access. You will ensure that robust data integrity is maintained in accordance with all related regulations.
• As part of the Quality Assurance Team you will be accountable for up to 5 Key Quality Process such as: CAPA, Recall, Regulatory Updates, Complaints, Deviations, Change Control, Trends, Environmental Monitoring, Supplier Assurance, Stability, Documentation, Quality Metrics, Audit & Inspection, Quality Risk Management, Data Integrity and Validation.
• Produce regular reports detailing the status of the PQS for dissemination to the Head of Quality, QA Manager, Production Management, Managing Director and Audit/Risk Committee.
• Escalation of issues to the Head of Quality / QA Manager.
• Generation and GMP approval of key documentation within the PQS.
• Conduct internal audits of the PQS as per the defined audit schedule.
• Assist with periodic Regulatory GMP/ GDP Inspections and site preparation.
• Lead and assist internal audits and inspections by clients.
• Lead or take part in gap analysis, risk assessments and risk management.
• Drive the timely implementation of risk-based changes and manage quality led improvement projects.
• Lead investigations to determine root cause and identify effective CAPA
• Ensure that SOPs are complied with, and processes and procedures kept current.
• Maintain awareness of changes to quality regulations and guidelines, participating in the assessment of any business implications of these changes.
• Identify and deliver training on GxP topics and Quality Management System processes.
• Undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
• Ensure compliance with COSHH and Health and Safety regulations and departmental SOP’s.
• Ensure that all related ePQS SOPs are raised, approved, controlled, and maintained.
• Ensure that there is a mechanism in place to ensure that all staff receive appropriate training (induction, refresher, and update) and have access to the ePQS.
• To provide reports and trend analysis on the effectiveness of the ePQS at regular scheduled quality meetings.
• To review the ePQS to ensure that it matches the needs and requirements of all users, and that any changes are promoted for awareness.
• Act as the QA lead presenting the ePQS to an auditor.
• Undertake any additional tasks and projects as required by the Head of Quality/ QA Manager
• Participate in the out of hours rota system for monitoring the environmental status of the building and its equipment. Be part of the on-call rota as required.

SECONDARY DUTIES

• Undertake and record continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
• Support the development of activities and policies aimed at improving the effectiveness and efficiency of the service and improvement of the quality management system.
• To support the training and development of Production and QA staff.
• Other duties as required by the Head of Quality/ QA Manager.

This job description is not intended to be exhaustive. The post holder may be required to be flexible and take on projects and responsibilities as the company grows.

SUMMARY

We are looking for a person who can identify and use relevant understanding, methods, and skills to address broadly defined, complex problems. It includes taking responsibility for planning and developing courses of action as well as exercising autonomy and judgement within broad parameters. It also reflects understanding of different perspectives, approaches or schools of thought and the reasoning behind them.

QUALIFICATIONS

• BSc in a scientific discipline or equivalent.

ESSENTIAL EXPERIENCE

• At least 5 years of working within a GXP environment.
• Substantial experience and knowledge of regulatory guidance relating to Pharmaceutical Quality Management (GMP, ICH Q10)
• Previous experience in a QA role, experience in a Sterility role would be an advantage
• Have led QA related Improvement Activities
• Knowledge and awareness of the principles of QA, with in depth experience of at least 2 elements of the PQS

SKILLS & ATTRIBUTES

• Ability to write procedures, protocols, and review documentation.
• Demonstrable working knowledge of GXP
• Ability to work within critical timelines
• Clear, concise, and confident when communicating both verbally and in writing to use these skills to convince others to buy into proposals and plans.
• Ability to lead, support, and interface effectively with projects and motivate cross functional teams.
• Meticulous attention to detail
• Has a drive to put patients first
• Personable and interacts well with people internal and external to the organisation
• Motivates and delegates appropriately to achieve business objectives.
• A hunger to learn more to become an expert in your domain
• Confident to always ask with any process or task, can it be better?
• Wants to contribute and be a part of our company community
• Dedicated to continually progressing in your career
• Ability to work with a range of diverse colleagues.
• Self-motivated and energetic

DESIRABLE EXPERIENCE

• Previous experience with electronic quality management systems.
• Computer system process mapping (validation/compliant gap analysis as well as Data Integrity evaluation)
• Can use own initiative to deliver results
• Adaptable and willingness to learn new skills