Quality Assurance Engineer
Quality Assurance Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Plan and conduct independent audits to assess compliance with regulations guidelines and operating procedures. Prepare and distribute reports of findings to supervisor operations staff management and customers. Provide consultation in interpretation of regulations guidelines policies and procedures. Support management in promotion and assessment of compliance to regulations guidelines and corporate policies.
Responsibilities:
- Plan schedule conduct report and close audit activities in any of the countries involved with contracts to assess compliance with applicable regulations/guidelines customer requirements SOPs and project-specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute reports to operations staff management and customers.
- Provide interpretation and consultation to project teams on regulations guidelines compliance status and policies and procedures.
- Provide consultation to customers and monitors in the interpretation of audit observations and formulation of corrective action plans.
- Manage Quality Issues.
- Present educational programs and guide operational staff on compliance procedures.
- Review approve investigations Root Cause Analysis (RCA) Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues Audits Inspections or during similar QA activities.
- Provide quality assurance consultancy activities and projects for clients within budget and established timelines.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Host audits/inspections ensure proper conduct of customer-initiated audits and mock regulatory inspections and assist in regulatory facility inspections.
- May perform GLP Archivist duties where needed.
- Manage/oversee quality events updates in eQMS and/or maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
- Lead/collaborate/support in QA initiatives/projects for quality process improvements.
- Assist in the training of new Quality Assurance staff.
- Bachelors Degree Preferred.
- 5 years of experience in pharmaceutical technical or related area of which 3 years in Quality Assurance. GXP experience. Equivalent combination of education training and experience.
- Knowledge of word-processing spreadsheet and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem-solving risk analysis and negotiation skills.
- Strong training capabilities.
- Effective organization communication and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers managers and clients.
Employment Type
Remote
Company Industry
Key Skills
- Test Cases
- Performance Testing
- Quality Assurance
- SOC
- Agile
- Debugging
- Jira
- Perl
- Software Testing
- Test Automation
- Scripting
- Selenium
