qa specialist in Italia

posted:
location
Italia, Lombardia
job type
Indeterminato
reference number
2869
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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. The role holder will provide guidance to site personnel, with a focus on performing deviation investigations, CAPA development and implementation Cleaning Validation, and Change Control through knowledge of quality concepts, investigational techniques and root cause analysis.

Key responsibilities:

  • He/she ensures that products manufactured are compliant with approved company policies, processes and procedures.
  • He/she acts as a Subject Matter Expert to provide quality knowledge and support to manufacturing, engineering, QC laboratory and supply chain verifying the GMP compliance.
  • He/she leads and coordinate investigations into Deviations recorded during production activities. Use Root Cause Analysis and other techniques to ensure root causes are correctly identified and strong CAPAs initiated.
  • He/she reviews and archive deviations, investigations, and CAPAs.
  • He/she assists in the writing and checking of  SOPs, Protocols, Batch Records and other GMP related documents.
  • He/she leads/ assists with company training needs.
  • He/she drafts of Quality reviews.
  • He/she supports investigations into customer complaints.
  • He/she defines the Cleaning Validation Records, coordinating all the connected activities and managing the potential deviations.
  • He/she ensures that records (paper and electronic) are properly filed, secured, and controlled and easily retrievable in the quality department in accordance with Data Integrity expectation
  • He/she checks and archives the documents drafted by the production plant (equipment and location status).
  • He/she assists the QA Manager and the Audit and Process Specialist in the organization and execution of the clients’ audits, regulatory agencies and the subsequent follow up of the corrective actions.
  • He/she leads/assists self-inspections.

Skills & qualifications

  • Bachelors Degree in Science or related (Chemistry, Microbiology or Biology preferred).
  • Experience in QA, manufacturing or Quality Control in the pharmaceutical industry.
  • Experienced in working to AIFA, US FDA, and other Regulatory Authority standards.
  • Proficient (excellent) English verbal and written communication skills.
  • Good Communication and Team working skills, with the ability to work under own direction.
  • Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint,  Access).
  • Experience with Trackwise ® QMS software would be an advantage.

If you are interested in this job position please send your  CV to supporto2.professionals@randstad.it with  “QA Specialist” as e-mail subject.

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