QA Specialist
- Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures.
- Prepare CofC and CoAs.
- Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions.
- Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods.
- Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities.
- Review and approve Test Method Development, Validation, and Transfer activities in support of the Analytical Sciences department.
- Review and approve Stability Studies protocols and reports.
- Support the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions.
- Support the Audit Team with during external and internal audits.
- Provides support to the program management office with the review and approval of the design transfer package documentation.
- Provides Quality support for throughout the product lifecycle to include the review of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives.
- Preferred BS in Engineering, Biology, or other technical related degree
- A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations.
- Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
- Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.
- Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility.
- Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP and other regulations.
- Knowledge of Good Manufacturing Practices & Good Documentation Practices
- Able to communicate effectively and work within cross-functional teams.
- Excellent oral and written communication skills with strong technical writing experience required.
- Experience in internal / external audits, identify findings, drive resolution, and provide closure report
- Proficient skills in solving complex problems and ability to bring issues to resolution.
- Experience working globally with diverse teams and cultures
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position in a dynamic, international team of highly skilled professionals
- Various opportunities for personal and professional development within a global organization
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