Title: Back up QP
Location: Hybrid / will be a mix of remote with some onsite days required in Lisbon, PT
Start Date: Immediate need
Duration: 6 months plus
Time Commitment: Preference is for a candidate with full-time availability but may be able to work if candidate can do 3 or more days per week commitment
Description:
The client is looking for a skilled, Portuguese speaking QP to perform batch certification of secondary packaging activities for commercial and experimental human use drugs. Ideally, the client would like a candidate with close to full-time availability but there may be flexibility.
Responsibilities:
- Ensuring compliance with GMP.
- Verifying all documentation generated for and during each of the processes performed.
- Issuing Certificates of Compliance for the manufacturing operations developed at this facility.
- Ensuring that an 8-hour on-site self-inspection is carried out per year and monitoring all actions arising from them.
- Providing annual training for staff relevant to manufacturing operations (4 hours including testing).
- Attending in-person inspections for renewal of the Good Manufacturing Practices Certificate and developing and monitoring all actions arising from them (this inspection is every 3 years).
- Attend routine inspections by competent authorities in person.
EU: Qualified Person (QP) – Pharmalex, PT (237705)