(CSV) Quality Assurance Systems Specialist
Guildford, Surrey, United Kingdom
Full Time
Experienced
General Information
Position Summary
QA Systems Specialist – eQMS & CSV Projects will be leading and supporting the implementation, migration, validation, and ongoing management of key electronic Quality Management Systems (eQMS) and pharmaceutical computerised systems at MedPharm. This includes acting as a Subject Matter Expert on ETQ, MasterControl, and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GAMP 5, Annex 11, and applicable regulatory standards.
Essential Functions
None
Education and Experience
While performing the duties of this job, there may be certain physical demands required for the position.
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
| Title: QA Systems Specialist – eQMS & CSV Projects | Date: 30 Apr 25 |
| Site: MedPharm Limited, Guildford, UK FLSA Status (US Only): | Department: Quality Assurance Reporting To: Director, Quality Assurance (UK) |
Position Summary
QA Systems Specialist – eQMS & CSV Projects will be leading and supporting the implementation, migration, validation, and ongoing management of key electronic Quality Management Systems (eQMS) and pharmaceutical computerised systems at MedPharm. This includes acting as a Subject Matter Expert on ETQ, MasterControl, and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GAMP 5, Annex 11, and applicable regulatory standards.
Essential Functions
- To effectively manage key Pharmaceutical Computerised System projects: delivering according to plan.
- To have a good working knowledge of Computer System Validation and its practical implementation at MedPharm.
- Lead and support the migration to new electronic Quality Management Systems (e.g., MasterControl, ETQ), ensuring smooth transition and compliance throughout all phases.
- Act as the Subject Matter Expert (SME) for eQMS platforms including ETQ and MasterControl – provide training, troubleshooting, and ongoing support.
- Own and manage system lifecycle documentation – URS, risk assessments, IQ/OQ/PQ, data migration plans, and SOPs.
- To promote a culture of acceptance to change in support of an ongoing programme of companywide improvement.
- Provide regular updates to Senior Management and key stakeholders highlighting risks and issues with existing systems, new system implementation and development.
- Provide assistance to employees working on Computerised System projects.
- Ensure adherence to GAMP5, EUDRALEX Volume 4 Annex 11 & 15, GLP and latest industry guidance during project activities.
- To ensure that all key process personnel are appropriately trained prior to implementation of a new Computerised System procedure.
- Drive post-implementation reviews and continuous improvement of computerised systems.
- To support the QMS as a subject matter expert on Computer systems used to store and process pharmaceutical data.
- Maintain compliance and audit readiness for all electronic systems.
- To act as the GLP Archivist and manage archiving process.
- Mentor users and super-users; deliver training programmes on validated systems.
- Heads of Department
- Senior Management
- Quality Assurance
- External Contractors (including specialists)
- Vendors
None
Education and Experience
- Bachelor’s or Masters’ degree in Life Sciences, Engineering, Computer Science, or related discipline desirable but not essential.
- Training in Computer System Validation or GAMP 5 preferred.
- Computer System Validation training desirable.
- Proven experience working with ETQ, MasterControl, or similar eQMS platforms – configuration, administration, and user training.
- Strong working knowledge with CSV and GxP system implementations in a regulated pharmaceutical or life sciences environment.
- Hands-on experience with CSV activities relating to Empower CDS, including:
- Validation of new Empower installations and version upgrades
- Data migration and system archiving
- Management of audit trails, user access, and data integrity in Empower
- Demonstrable success in leading system migrations or large-scale QMS digitalisation projects.
- Experience in writing and maintaining validation documentation in line with GAMP 5.
- Good working knowledge of Computer System Validation.
- Familiar with electronic quality management systems (eQMS).
- Familiar with environmental monitoring systems.
- Experience working within a Quality function on computer systems integration projects.
- Highly organised
- Effective communicator able to translate technical concepts to non-technical users.
- Strong project management and change control skills.
- Able to influence and drive adoption of new systems across multidisciplinary teams
While performing the duties of this job, there may be certain physical demands required for the position.
- Regularly required to sit at a desk and use a computer
- May occasionally be required to stand, walk, bend, or reach
- Occasionally required to lift items up to 10kg, such as document boxes or computer equipment
- Work is typically performed in a standard office environment
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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