QA Specialist Medical Industry Experience - 4116
QA Specialist Medical Industry Experience - 4116
Posted on :
26-08-2024
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Posted on :
26-08-2024
Job Description
Role: QA Specialist (Medical Industry)
Scope of the role
The QA specialist role includes but may not be limited to supporting the director of quality with a precise focus on document control records training and vendor management throughout the governance of our quality management systems and project lifecycle including harmonization of processes across functional areas for internal and external operations. Other responsibilities may be provided under the direction/discretion of executive management and project resource needs.
Main Responsibilities
- Supporting Quality Operations and Quality Management Systems for internal and external operations maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas.
- Assist with formatting and administration of electronic document workflows as well as chain of custody issuance and archival of related QMS records including training CAPA complaints vendor qualification and audit activity.
- Support crossfunctional teams in processing document change requests document approvals and archival.
- Support Regulatory Affairs with Quality reviews of source documents for submission modules of CMC sections as directed and participate in crossfunctional meetings with RA/QA activities when directed.
- Support Clinical Operations with document collection and quality reviews as directed to ensure the principles of good documentation practices are being applied.
Requirements
- Selfstarter with strong problemsolving skills with the ability to take direction as well as work independently.
- Critical thinking with the ability to communicate crossfunctionally across all levels of the organization.
- Highly organized with attention to detail with the ability to manage multiple projects and meet deadlines.
- Stay abreast of GCP GMP ICH and regulatory requirements as they apply to the current operations model.
- Auditing certifications.
Employment Type
Full Time
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