Aps & Sterility Specialist - Lombardia, Italia - Confidenziale

Confidenziale

Azienda verificata

Lombardia, Italia

1 settimana fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

impiegoWhen youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

Your work will have real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific InformationMonza (MB)How will you make an impactThe resource will become part of a lively and dynamic team which is responsible for the aseptic validation process of products manufacturing in Monza site, by managing Aseptic Process Simulation (APS) documentation and supervising on the floor operations, in close contact with Clients technical and quality teams, and in accordance with Regulatory guidance.

APS & Sterility specialist is a key element for the Company core business. He/She cooperates with Project Managers, Process Engineers and Client technical teams, within Monza site Quality Unit.

What will you do Analysis of technical documentation related to new protocols;Issuing APS protocols and reports for, in accordance with GMP and corporate standards; Collect necessary information by involving relevant functions.

Processes object of APS are:
manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes), as well asmodern pharmaceutical technologies (i.e.

fill finish processes under isolators);Issue of manufacturing instructions (MBR) for APS batches;Issue of technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventionsEnsure correct management and archiving of documentation in line with GMP and internal procedures;On-the-floor overlooking of manufacturing activities related to APS batches;Support in preparation and update of partment SOPs.

Ensure that all relevant activities are adequately evaluated and managed through change control managementSupport in preparation and participation to Clients and Regulatory audits with regards to APS activities.

Ensure that our client service delivery performance is maintained at the highest level, by building strong relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner.

Ensure an adequate reporting to the Area Management about potential issuesHow will you get hereDegree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / BiotechnologyAt least 1-2 years of experience in pharma/chemistry industryKnowledge, Skills, AbilitiesEnglish and Italian fluentKnowledge of sterility assurance conceptsKnowledge of pharmaceutical legislation and national/international lawsGood social skills, team workingPropension to preparation of technical documentationCritical sensibility, attention to details, precisionOrganizational skills