Quality Assurance Senior Officer/Auditor (MP/QASOAD)
- United Kingdom -- England -- East Midlands -- Leicestershire -- Loughborough
Thursday, May 20, 2021
We are looking to recruit an experienced QA Senior Officer/Auditor within our Quality Compliance Team reporting in Loughborough, Leicestershire!
Quality Assurance Senior Officer/Auditor Duties:
- To lead the MPL (Morningside Pharmaceuticals limited) external audit program as required with regard to planning and reporting of status of supplier audits (including external manufacturers / suppliers / critical service providers);
- To schedule, conduct, report and close assigned External and Internal Audits in accordance with GMP. This is expected to be up to 30-50% of the role and will involve some travel within UK and EU/EEA.
- To lead specific projects to develop, prepare and implement revisions, additions, and continual improvement of our Quality Management System (QMS) by preparation, training and implementation of additional policies, SOPs and Work Instructions.
- To support activities to ensure that all systems, including but not limited to the QMS Documentation, CAPA system, Change Control procedure, Deviation system, Technical Agreements, Training, Supplier and Customer approvals and other documentation systems are maintained and administered in a timely manner.
- To ensure that timely, full, and adequate support with respect to availability of all data and documentation required by Qualified Persons for batch certification and release activities.
- To create and provide reports for the Head of Quality and QPs as well as other Stakeholders within the business.
Quality Assurance Senior Officer/Auditor Requirements:
- Relevant degree in a life science discipline.
- Proven industry experience of auditing within the pharmaceutical sector, with experience of auditing manufacturing/packing sites, laboratories, and warehouses.
- A working knowledge and practical experience of Quality Management Systems.
- Excellent communication skills, both verbal and written.
- Excellent organisational and time management skills.
- Good reasoning and a problem-solving capability.
- Must be willing to travel.
- Being an accredited Pharmaceutical Lead auditor would be advantageous.
Quality Assurance Senior Officer/Auditor Benefits:
- Profit share
- Pension scheme
- Private Healthcare – medical insurance and cash back schemes
- Life assurance cover
- 24 days’ holiday plus Bank Holidays
- Income protection
- Excellent opportunities for growth and progression
- Free parking
- Competitive Salary
- Monday-Friday: 9.00am-5.00pm
If you think that you are suitable for this Quality Assurance Senior Officer / Auditor role, please apply now!