Bio-Kinetic Europe Limited
Job Description
Job Title:
Reporting to:
Quality Assurance Specialist
QA & Regulatory Affairs Manager
Scope:
The Quality Assurance Specialist will contribute to the BioKinetic Europe Ltd (BKE) Quality
System to maintain compliance with Good Clinical Practice and Good Manufacturing Practice.
All duties assigned must be carried out in accordance with BKE policies and procedures.
Key Duties and Responsibilities:
Trial Master File (TMF)
 Provide administration for the organised and timely collation and filing of BKE trial
master file documents and records.
 Liase with Project Management and Data Management departments to prepare and
review TMF files for client and / or inspection visits, ensuring complete files are
available.
 Ensure TMF issues are communicated internally and followed up with appropriate
actions.
 Ensure the QA & Regulatory department is kept informed of the status of TMF
documentation.

Standard Operating Procedures and Controlled Documents
 Liase with BKE departments to provide administration for ensuring organised and
timely review, approval, distribution and notification of BKE SOPs, controlled
documents and related logbooks.
 Ensure the BKE SOP training matrix is approved, and up to date with current job
positions and training requirements.
 Ensure the BKE portal and Master Study Folder is kept up to date with current BKE
QMS controlled documents.
 Maintain the BKE Quality System superseded documents and archive list.
Equipment
 Ensure the BKE equipment calibration and maintenance list is kept current and
accurate.
 Provide organised and timely equipment calibration and maintenance notifications to
BKE departments.
 Work with other BKE departments to ensure new equipment and / or study specific
equipment is logged and adequate procedures are available.
 Maintain the equipment calibration and maintenance files, ensuring the records are
kept complete, accurate and available for audit and / or inspection.
 Ensure equipment logbooks are available to BKE departments as required.
 Review of equipment Field Safety Notices, communication to applicable departments
and applicable follow-up.
 Provide support for Kelsius system access privileges and Kelsius trending.
 Maintain the system for controlling BKE access fobs & keypad, ensuring fobs are
issued, tracked and retrieved in a timely manner.
23APR15
Training
 Provide administrative support for BKE’s training trackers (Medical Emergency, GCP
etc.)
 Ensure TMF study training records are complete and available for client and / or
inspection visits.
 Assist with training file checks (checklist audit).
Quality System
 Assist the QA & Regulatory Affairs Manager with the BKE audit plan through checklist
audits and Corrective and Preventive Action (CAPA) system.
Other
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Record all training in an accurate and timely manner.
Accountable for completion of tasks within assigned deadlines.
Manage and organise multiple priorities.
Maintain confidentiality as per Data Protection Act and support all company duties
and policies.
Assist and carry out any other duties within reason and capability as required by the
QA & Regulatory Affairs Manager or Directors.
Essential Criteria:
Science Degree or equivalent
Proven experience of Microsoft Office word and excel
Proactive team work and excellent communication skills
Excellent attention to detail
Ability to work as part of a team
Flexible approach to work and can demonstrate a professional image
Ability to work under pressure in a busy environment
Desirable Criteria:
Experience in a similar role or in areas above
Recognised Microsoft Office qualifications
23APR15