Laboratory, R&D, Quality Management / Job Experience
Quality Assurance Administrator
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
Documentation:
* Full, neat, and accurate competition 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
* Maintain annual training plan
* Schedule annual trainings
* Manage Personnel General Training matrix
* Manage Personnel Technical Training matrix
Archive
* 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
* 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
Please, include the job position in the subject of your email in the following format TPUK: QA Administrator.
Job Type: Full-time, on-site
Company benefits include:
- Company pension
- Free and on-site parking
- Private Healthcare
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