- Responsible for facility compliance with regulatory commitments, in-house requirements and GMP.
- Introduction of quality systems by means of research and assessment of current industry practices and GMP requirements.
- Preparation of procedures and policies for area of responsibility.
- Responsibility for maintenance and development of GMP awareness facility-wide, including: preparation and execution of training programmes, assessment of GMP training requirements, and execution of internal GMP auditing.
- Investigation for QA review of all GMP critical documents.
- Participate and manage in the introduction and maintenance of Global Quality Management Systems (GQMS)
- In-house auditing.
- Line clearance procedures.
- Exception and deviation management e.g. deviations, Alarms, OOS, etc.
- Documentary review.
- Support quality aspects of materials management including supplier approval, supplier complaints and specification management.
- Maintenance of site master file.
- Preparation of annual reports and activities i.e. Product Quality Review, Mock Recall etc.
- Trending of complaints.
- Maintain manufacturing licence, variations etc.
- Provision of support and assistance in execution and control of validation programmes.
- Carry out all activities in compliance with company Safety and Environmental Standard Operating Procedures.
- Participate in team-based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the Envision area.
- Other duties as assigned supervision management.
Key eGMP Responsibilities:
- Maintain, develop and manage QA systems.
- Follow Standard Operating Procedures while carrying out duties at all times.
- Participate fully in all GMP and operational programs and complete all Training Records in an accurate and timely manner.
- At least 5 years’ experience in a GMP regulated environment.
- Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
- Ability to evaluate and assess information to determine appropriate risk and required actions is critical.
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org