Shauna Bunn Talley
- Role
- Associate Principal Scientist (Associate Director) - Site Cmc at Merck
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Shauna Bunn Talley
I am an energetic and career-focused professional with a robust background in laboratory…
Experience
Associate Principal Scientist (Associate Director) - Site Cmc
May 2020 — Present
Manage the interface between the Manufacturing Site and Regulatory Chemistry, Manufacturing and Control (CMC) to maintain product regulatory conformance. Specific responsibilities include: Ensuring that the information included in regulatory submissions/filings is aligned to plant information and supports future compliance and maintenance. Ensuring that regulatory-impacting changes are correctly identified and assessed for regulatory impact. Work with other CMC teams to ensure that regulatory post-approval changes are managed & processed efficiently through to last market approval and implementation. Ensuring that regulatory information is correctly maintained, updated and interpreted, using our company Regulatory Information systems and tools. Working with site Quality, Technical and Supply chain functions to ensure that product is released in accordance with the relevant Global Marketing Authorizations. Acts as a point of escalation for regulatory compliance or related issues that may arise at the manufacturing site and a Subject Matter Expert in the management and resolution of any such issues.
Skills
- Hplc
- Capa
- Glp
- Quality Auditing
- Quality System
- Testing
- 21 Cfr Part 11
- Microbiology
- Gmp
- Fda
- Cleaning Validation
- Lims
- Aseptic Processing
- Pharmaceutical Industry
- Biotechnology
- Sop
- U.s. Food and Drug Administration (Fda)
- Quality Assurance
- Change Control
- Environmental Monitoring
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