Expires soon Recipharm Pessac

QUALITY ASSURANCE PROJECT (H/F)

  • V.I.E.
  • Milan (Milano)
  • Design / Civil engineering / Industrial engineering

Job description

Company:
Mitim, part of Recipharm Organization in Italy, is a plant with around 270 people located in Brescia, about 90 km east of Milano, where sterile powder for injection in aseptic conditions are produced.
We perform aseptic filling of sterile lyophilised powder, penicillin’s and cephalosporins for injection. Furthermore, we also produce sterile ampoules (small volume glass ampoules by terminal sterilization).
The site is inspected on regular bases by FDA and AIFA Authorities.
The candidate, joining the Quality team, will have the opportunity to improve the knowledge of sterile productions as well as of the Pharmaceutical Best Practices.
Position and main duties :
The candidate, joining the Quality team, will have the opportunity to improve the knowledge of sterile productions as well as of the Pharmaceutical Best Practices.
Working in the Quality Assurance Department and will be involved in the following activities:
- Master Batch Record process
- Product Quality Review process
- Quality System Management, reviewing and distributing quality procedures
- Deviations summaries and complaints reports for final customers
- Update of Site Master File
- Process validation, writing and reviewing protocols and reports
- Equipment Qualifications, writing protocols and reports and prepare documentation for final customers
Please notice that all documents above are in English or in bi-lingual in Italian and English.
Skills and expériences:
- Italian: the knowledge of basic Italian will be of help for a quick induction and integration in the organization/work
- Pharmacist or Chemistry/Microbiology/Biotechnology degree
- Good skills in presentation and communication
- Good skills in cooperation with internal and external functions
- Self-motivated and able to work independently.
- Good ability to work with cross-cultural teams.
- knowledge and/or previous short experience in the Pharma industry is an advantage.