DirecciónLocation : España, Zaragoza
We are seeking a Microbiological Supervisor to support the QC Manager to ensure that Quality Control processes for materials acceptance, batches quality control, and QC equipment validation / qualification are implemented and fully compliant to cGMPs regulation, corporate and national guidelines.
This role will work directly with the Microbiologic Quality team and reports to the Microbiological Responsible.
Key Responsibilities :
- Acceptance of raw materials, packaging materials,and semi-finished products according to specifications.
- Ensure that all QC processes, equipment and software are validated / calibrated according to the Validation Master Plan.
- Ensure that all methods used in QC analysis are validated according to SOPs and cGMPs; but also support the adequacy of the SOPs of QC Department.
- Perform the APR achievement according to the calendar.
- Support the audit trail review of the quality control equipment software; as well as the verification of the data integrity of the QC software.
- Maintain, review and approve the records of the QC activities.
- Ensure that all QC materials are properly and safely stored, identified, labelled recorded, and monitored according to SOPs and specifications;
to ensure that the stock of materials and reagents are available and ordered.
- Ensure 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.
- Collaborate with QC Manager for the periodical self-inspections and external audits (Health Authorities, Certified Bodies, Supplier).
Hace 2 horas
