Senior Quality Assurance Manager Position
3 days ago
The Quality Assurance Specialist is responsible for reviewing and approving executed batch manufacturing records and batch packaging records submitted from manufacturing sites.
Key Responsibilities:- Review and approve electronic in-process control data, critical process parameter logs, and environmental monitoring results uploaded from the site.
- Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
- Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports.
- Review, assess, and approve electronic change control proposals via QMS software.
- Conduct remote review of deviation reports, root cause analyses, and corrective action proposals.
- Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria.
- Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site.
- Proficiency in sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.
This is an opportunity to develop your expertise in quality assurance and contribute to a collaborative team environment.
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