Title: Principal Quality Engineer
Summary: A leading company in specialty pharmaceuticals is looking to add a Principal Quality Engineer to their team! This is a well-established company with over 150 years of experience in the industry, focusing on specialty pharmaceuticals to treat severe conditions. This role will oversee the QA management and provide leadership to ensure that regulatory requirements are met.
The Principal Quality Engineer will be responsible for:
- Supervise the QA team responsible for batch record review and product release.
- Author, assess, and approve exceptions, change controls, and CAPAs within the quality system.
- Lead investigations for OOS results and customer complaints.
- Drive strategic quality improvement projects and initiatives.
- Facilitate site transitions to align with drug product expectations.
- Act as the site's lead auditor.
- Ensure compliance cGMP guidelines.
- Identify, assess, and rectify gaps in data integrity.
Qualifications:
- 5+ years of experience in QA/QC within pharmaceuticals
- Preferred ASQ CQA credentials
- Experience in FDA CFR and ICH requirements
- Experience in cGMP environment
- Six Sigma and/or Lean manufacturing experience
