Offer summary

Qualifications:

Diploma or bachelor's degree in a related field., 1 to 3 years of relevant experience., Knowledge of regulations and standards in clinical research., Proficiency in MS Office applications..

Key responsibilities:

Coordinate and support the Quality Management System documentation.

Assist with audits, inspections, and meetings related to quality assurance.

Review and triage requests and documents within the electronic QMS.

Support continuous improvement activities within the QA department.

Job description

Provides coordination and Quality Management System (QMS) support to the Quality Assurance Department. Responsible to support maintenance, monitoring, review and publishing of Quality System Documents supporting the Quality Management Systems (QMS). Assists with audits, inspections and meetings as required.

QA Coordination and Document Management (5565%) Independently review and triage high volume of incoming requests to QA and assign to QA staff based on area of expertise.
Independently review high volume of document change requests in the electronic quality management system (eQMS) and assign to QA staff based on area of expertise.
Perform quality system document reviews using the eQMS and document quality checks as assigned to ensure documents meet the requirements of the QMS.
Liaise with quality system document owners as required to seek clarity on processes outlined in quality system documents.
Support QA personnel with publishing quality system documents.
Provide input to QA department processes to support continuous improvement activities.

QA AuditsInspection Management (1520%)
Assist with external audits and regulatory inspections, which may include preparation for auditinspection (e.g., schedule audit participants, distribute audit agenda, book and prepare the audit meetings).
Create audit folder and upload requested documents to shared folder for auditor review.
Support QA audit team in managing auditor requests during the auditinspection.
Generate recordnotes of audit discussions and findings.

QA Meetings (1015%)
Plan and coordinate QA Department meetings including scheduling and agenda planning.
Generate QA Department meetings minutes and circulate for review.
Provide meeting support to QA team members as required.

Additional Knowledge and Skills
Diploma or bachelors degree in a related field
1 3 years of relevant experience
Quality Assurance or Clinical Research specialty preferred.
General knowledge of regulations and standards governing global clinical research practices
Proficiency with MS Office (Word, Excel, Power Point, Outlook and Teams)
Strong written and verbal communication skills. Strong time management skills.