Sterility Quality Assurance Senior Specialist
Azienda:
Human Value

Context

Our client is a prestigious multinational company leader in the pharmaceutical sector. The company, solid and very innovative, is experiencing a phase of strong investments that will strengthen its leadership position on the reference market. In order to strengthen one of the Italian plants, based in the province of Frosinone, we are looking for a:

Sterility Quality Assurance Senior Specialist- Rif. H20.467
Workplace: Province of Frosinone
 

Role

The ideal candidate will understand the risks and the strategies necessary to assure the correct production of Sterile Products.  This requires identifying critical assets, assessing threats and risks and ensuring an effective process of notification and communication.
The ideal Areas of Competence are:
  • Expertise in sterile production (Aseptic Tecnique, RABS, Isolator); Aseptic Process Simulation (Aseptic Tecnique, RABS, Isolator): design during lines start-up and routine plan;
  • Expertise in contamination control strategy elements (environmental  sampling plan and trends, personnel qualification, cleaning program, microbial excursion);
  • Expertise in start up of aseptic filling lines, RABS, Isolator and collaboration in multifunctional teams;
  • Expertise in Risk Assessment related to Sterility Assurance topics;
  • Expertise in Biologics production (Aseptic Tecnique, RABS, Isolator): investigation, processes, controlled temperature storage;
  • Verifying the proper issuing of the documentation to support the sterile production processes (Aseptic Tecnique, RABS, Isolator);
  • Enabling corrective and preventive measures to reach the efficiency and efficacy of sterile production processes (Aseptic Tecnique, RABS, Isolator);
  • Proactively cooperating to update internal procedures in allignement with new regulatory requirements, both internal and external;
  • Contributing to improvemnts to all procedures impacting Sterility Assurance;
  • Capability to create network with all sites experienced in Sterility Assurance.

Requirements

  • Specialist Degree in Chemical Pharmacy, Industrial Chemistry, Biological Sciences and experience in the role or similar roles inside quality operations and production or quality control;
  • 5 years experience diversified in different Functional areas and/or Quality;
  • Advanced and fluent English knowledge;
  • Robust knowledge of, manufacturing processes, products,documentation and procedure; 
  • Solid expertise of asepsi techniques (sterile area) or processes applicable to the department where operating;
  • Knowledge of software and hardware tools commonly used;
  • knowledge of Trackwise.
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DATA DI PUBBLICAZIONE
26/10/2020
LUOGO
Lazio; Lazio/Frosinone

SETTORE
Chimico, farmaceutico

CATEGORIA - RUOLO
Produzione/Responsabile qualità

ANNI DI ESPERIENZA
da 3 a 5 anni

CONTRATTO
Tempo indeterminato

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