qa specialist in cernusco sul naviglio

posted
job type
indeterminato
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job details

posted
location
cernusco sul naviglio, lombardia
job category
Pharmaceuticals
job type
indeterminato
experience
2 - 5
reference number
4398
apply now

job description

The Pharmaceutical division of Randstad Professionals, specializes in search & selection of candidates in the middle and senior management, is engaged by a multinational Pharmaceutical company in the search for an experienced:

QUALITY ASSURANCE SPECIALIST

 

Working as a part of broader QA team, this position is responsible to support Quality Assurance activities on a manufacturing site, producing sterile API products. The successful candidate will already have experience in GMP areas in accordance with international standards and procedures.

Works as part of the project development team new product development activities ensuring compliance of project design (facility layout, URS, IQ, OQ, PQ, method transfer, etc) with corporate and site Quality Management Systems.

 

Main Responsibilities:

  • Ensures day to day activities comply with cGMP standards.
  • Review and management of Data in SAP (Batch and article material data, next inspection date, retest date, etc).
  • Establishment of Quality Management System actions within the Peptides Unit to ensure alignment
  • with the company.
  • Prepare and support the use of standard operating procedures (SOP) for activities related to GMP
  • and product quality Training on new procedures and new procedure revisions.
  • Supports the preparation and use of site documentation – Validation Protocols & Reports, Change Control, Deviation Investigations, CAPA, Cleaning Validation, etc.
  • Ensure development and transfer of Analytical Methods to QC are fully validated.
  • Maintains technical contacts with suppliers, and supports obtaining the necessary documentation e.g. development of Quality Agreements, for their validation and obtaining any import license.
  • Supports and performs annual monitoring of suppliers using quality data and reports collected during the year.

 

Skills & qualifications

 

  • Degree on Chemistry, Chemical Technology, Pharmaceuticals, Biology or similar areas of science
  • 3 - 5 years QA experience in API manufacture
  • Experience in QC, QA or production operations
  • Experience in SAP preferred
  • Project management skills

If you are interested in this job position please send your  CV to martina.larosa@randstad.it with  “QA Specialist” as e-mail subject.

 

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qualification

Laurea II Liv.