Responsibilities:
- Maintain oversight for status of individual batches, including all manufacturing process step start dates, sampling, testing, deviations, and release timelines.
- Provide daily status updates of all batches on behalf of CMO/EQ team.
- Update EM batch tracker and intake form (if applicable) at CMO daily with updated dates of process steps and investigations.
- Oversee status of all open investigations, batch release timing, and communicate Quality project lifecycle for the COVID-19 Vaccine Quality function on behalf of the assigned CMO.
- Collaborate with EQ team and CMO to ensure daily updates are accurate.
- Conduct daily query of deviations and investigations at site.
- Gather daily updates from EM site regarding deviations and investigations and work with Global Investigations team to ensure all Data Tracking Sheets are updated.
- Communication when needed regarding alerts of any nonconforming results, out of trend, or out of specification results.
- Understand risk and delays to batch release and communicate appropriately.
- Manage/track OMCL/CBER samples from final shipment to government facility.
- Build relationship and influence external partners to continuously enhance Quality culture and business excellence.
- Apply cGMP regulations and other FDA internal requirements to all aspects of the position.
Requirements
- Experience in sterile manufacturing processes under GMP.
- More than 10 years experience in pharmaceutical industry, working in the quality area with a similar role.
Conditions:
- Temporary position
- Very attractive and competitive salary- According to the skills and experience of the candidate.
-100% remote position
- Starting day: ASAP
