Watertown, MA, United States
$130,000 - $150,000
3 months ago
- Understand and implement all quality procedures with regards to GMP, ICH, and FDA requirements/guidelines.
- Review and approve Master and executed Batch Records for Drug Substance and Drug Product, stability protocols and reports, and specifications.
- Be in the front room during FDA inspections for NDA submissions and planned audits.
- Communication of findings to vendors responsible for the listed records and ensuring corrected documentation is received.
- Review all documentation for release of API and drug product for use in clinical and nonclinical studies.
- Liaise with all suppliers on overcoming CAPA, Deviation and Change Control issues that they may have.
Experience Required to be considered:
- 8+ years' experience within quality in the pharmaceutical/bio-pharmaceutical environment
- Drug supplier audit experience and knowledge of ICH Q3, Q7, Q9.
- Fluent with QMS Deviation, CAPA, NCR experience required, with eQMS experience highly preferred.
- Experience reviewing drug specifications SOP approvals and editing required FDA submission experience preferred