Quality Assurance Administrator

Southern Microbiological Services Ltd
Derby
1 week ago
Applications closed

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Quality Assurance AdministratorObjectives / PurposeThe 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 responsibilitiesSafety:

  • 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 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 up-to-date 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 up-to-date

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 formatTPUK: QA Administrator.

Job Type: Full-time, on-site

Company pension
Free and on-site parking
Private Healthcare

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