QA Engineer managing Corrective and Preventive Action program in compliance with regulatory standards. Supporting Quality Management System activities in the Medical Device industry.
About the role
- Supervising QA associates in PCI Pharma Services ensuring compliance with regulatory standards and effective quality management. Managing external audits and collaborating with production and customer service teams.
Responsibilities
- Responsible for the Supervision of the QA associates, ensuring that all site licenses are kept up to date
- Hosting external client audits
- Manages the KPIs and Metrics reporting to site management and Corporate
- Works closely with site management, production, and customer service to ensure customer requirements and timelines are met and comply with internal operating standards and regulatory standards (cGMPs/GMPs)
- Supervises the QA Associates
- Provides direction on dealing with issues during production and elevates issues to Sr. Director Quality Operations and site management as required
- Reviews and approves executed inspection and production related documentation
- Conducts training on PCI's Quality Management Systems, processes and performs annual GMP refresher training
- Initiates CAPA’s resulting from deviations, customer complaints, identified non-conformance, audits, or any other means of problem identification
Requirements
- QA certificate or equivalent experience
- University degree / college certificate in the fields of math, science, Quality Assurance or equivalent
- In-depth knowledge and experience with manufacturing and packaging processes
- 5 years in the pharmaceutical industry and knowledge of GMP’s
- Extensive computer knowledge and adeptness with various software programs including Microsoft Word, Excel, Outlook, and Database Management
- Excellent mathematical as well as written and oral communication skills
Benefits
- Exceptional attention to detail and accuracy in the maintenance of records and data
- Excellent organizational, and time management skills to ensure deadlines are met
- Effective interpersonal and teamwork skills
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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