Objectives / Purpose
The Quality Assurance Administrator should:
* Be aware of the safety implications of operations, ensuring compliance with working practices and procedures
* Actively contribute to the continual improvement of business development processes
* With the assistance of the manager, develop work schedules to achieve objectives
* Ensure compliance with current practices and procedures
* Co-operate as necessary with the audit team(s) to ensure that the audit process is effective and achieves its objectives
* Complete documentation as directed by relevant procedures
* Identify faults / process failure and report complex faults. Take appropriate remedial action when appropriate
* Contribute to project scope, design and implementation
Principal roles and responsibilities
Safety:
* Adherence to all relevant safety procedures
* Prompt reporting of any safety issues
* Adherence to customer safety requirements when on their site
Process Development:
* Continually looking to improve the processes that are in place
Scheduling:
* Assist in the development of plans to meet operational targets and individual goals
* Maintain schedules to achieve performance objectives
* Agreed deadlines met
Documentation:
* Full, neat, and accurate completion of documentation
* Good housekeeping and cleanliness
* Record activities in relevant database accurately and in a timely manner
* Complete all relevant company documentation fully
Audit:
* Provide appropriate information in a timely manner
Troubleshooting:
* Report all failures in a timely manner
* Report all Corrective Action / Preventive Action (CAPA)
QA:
* Comply with SOPs
* Discrepancies always raised
* Effectively manage quality assurance activities including change controls, Corrective and Preventive actions, training, document distribution
* Maintenance of Pharmaceutical Quality System documentation
* Ensure that the core current Good Manufacturing Practice (cGMP), Good Control Laboratory Practice (GCLP), and Data Integrity are maintained
* Initiate, write and review SOPs as required
* Continually look to improve the processes
* Send periodic reminders for outstanding quality records
Controlled Documents
* Manage the document control process
* Issue the controlled documents, make the documents effective
* Maintain up to date the General QA drive
Quality Trackers
* Maintain UpToDate the quality trackers
* Maintain Master Document Index (MDI)
* SST tracker
Logbook
* Distribute the logbooks, perform QA review before archiving the logbooks, physical archive of the logbooks
Personnel Training
* Maintain annual training plan
* Schedule annual trainings
* Manage Personnel General Training matrix
* Manage Personnel Technical Training matrix
Archive
* Archive quality records (work orders, SOPs, forms etc.)
* Keep physical archive UpToDate
Benchmarking and Projects
* Continuous improvement of benchmarking and expansion of services
* Project parameters to be met
Other Requirements
* Always present a professional image of the company
* Record all activities on relevant databases
* Handle incoming customer samples
* Assemble work packets
* Co-ordinate SOP / documentation management system (G-docs) and provide training to Tentamus Pharma UK staff
Skills required
* First degree in scientific discipline
* In depth knowledge and experience of MS Office applications
* Fully competent in oral and written communications with strong interpersonal and management skills
* Ability to work well and collaborate within a team environment
* Excellent communication skills in providing feedback and pinpointing improvements where needed
* Have keen attention to detail to ensure all products and services meet standard requirements
If you would like to apply for this role, please send us your updated CV to ApplicationsUK@tentamus.com.
Please, include the job position in the subject of your email in the following format TPUK: QA Administrator.
Job Type: Full-time, on-site
Benefits:
* Company pension
* Free and on-site parking
* Private Healthcare
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