09 sep
|
Novartis
|
Salamanca
09 sep
Novartis
Salamanca
About the Role:
Work location: Salamanca.
This is a unique opportunity to be involved in the start-up of the new ADACAP facility of Salamanca which construction is ongoing.
As Quality Control Manager you will ensure that Quality Control processes for materials acceptance, batches quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.
Furthermore, as Qualified Person you will ensure that every batch of a drug is produced and controlled with respect to the laws and conditions applied to the site which authorize the sale of the pharmaceutical fully compliant to cGMPs regulation, corporate and national guidelines and MA.
Key responsibilities:
As QC Manager:
- Manages the collaborators.
- Manages, coordinates, reviews and approves the execution of the analytical activities for the batch release
- Ensures the accomplishment of the ALCOA+ principles in all equipments and the activities performed in the Quality Control Labora
- Ensures, in collaboration with QA department, that out of specifications,
out of trend, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs
As deputy Qualified Person:
- Ensures that every batch of a drug is produced and controlled with respect to the regulations and conditions applied to the sit
- Active collaborate in competent authorities’ inspections and performs the operations resulting from these inspec
- Participate in the compliance of the local quality system to the GMPs and corporate guideline.
Diversity & Inclusion / EEO:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements:
Obligatory requirements:
- Education: Pharmacy degree is preferred / in alternative scientific degree in Chemistry or Biology.
- At least 2 years of experience in a Quality Control department or one
📌 Quality Control Manager (Salamanca)
🏢 Novartis
📍 Salamanca