QA Specialist
Guilldford, Surrey, United Kingdom
Full Time
Experienced
General Information
Position Summary
The QA Specialist will support the Quality Assurance department in maintaining compliance of computerised systems and electronic Quality Management Systems (eQMS). This includes contributing to validation activities in alignment with GAMP 5, Annex 11, and other relevant regulations. The role requires an understanding of Computer System Validation (CSV) principles and practical involvement in regulated environments.
Essential Functions
Key Relationships:
Travel requirements:
None
Education and Experience
Knowledge, Skills, and Abilities
Personal Attributes
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.
Other Duties
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 Specialist | Date: 26 Jun 25 |
| Site: MedPharm Limited, Guildford, UK FLSA Status (US Only): Exempt/Non-Exempt | Department: Quality Assurance Reporting To: Director, Quality Assurance (UK) |
Position Summary
The QA Specialist will support the Quality Assurance department in maintaining compliance of computerised systems and electronic Quality Management Systems (eQMS). This includes contributing to validation activities in alignment with GAMP 5, Annex 11, and other relevant regulations. The role requires an understanding of Computer System Validation (CSV) principles and practical involvement in regulated environments.
Essential Functions
- To maintain and improve Quality systems within the QA department including but not limited to, document control, supplier qualification, technical agreements, quality records, and internal / external audit programme.
- To have a good working knowledge of Computer System Validation and its practical implementation at MedPharm.
- Provide QA input into the creation of quality records, including change controls, deviations, out-of-specification (OOS) results, CAPAs, facilities and equipment documentation, audit responses, and other related records.
- 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 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.
- 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 and documentation .
- Support the reporting of key quality indicators.
- Approve / reject and review all protocols, methods, records and data generated in support of a clinical campaign and compile ready for QA review and release.
- Support management of the Quality documentation process.
- Assist with hosting clients and regulatory audits.
- To act as the GLP Archivist and manage archiving process.
- Mentor users and super-users; deliver training programmes on validated systems.
Key Relationships:
- Heads of Department
- Senior Management
- Quality Assurance
- External Contractors (including specialists)
- Vendors
Travel requirements:
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.
Knowledge, Skills, and Abilities
- 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.
Personal Attributes
- 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
Physical Demands and Work Environment
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
Other Duties
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.
Apply for this position
Required*