qa manager in Italia

posted:
location
Italia, Lombardia
job type
Indeterminato
reference number
2991
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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 MANAGER

The candidate will be responsible of the QA team and will ensure the compliance of the Quality System to the requirements of cGMP standards for the production of active ingredients and medicines. He/She will also ensure respect and compliance of operating procedures with current legislation, standards and quality standards established.

Main responsibilities:

  • He/she approves validation protocols, coordinates activities related to validation, approves the validation report (Process Validation: QA-SOP-019).
  • He/she approves validation protocols, approves the validation report (Cleaning validation: QA-SOP-003).
  • He/she approves validation protocols, approves the validation report (Validation of plant and equipment).
  • He/she coordinates the activities related to changes in the synthetic processes, verify that the changes related to equipment and instruments, are acceptable (Change control: QA-SOP-006).
  • He/she conducts self-inspections according to QA-SOP-026 (write report and propose correction).
  • He/she ensures that all the plant personnel receive appropriate initial training both about GMP and about specific operational tasks. He/she ensures that regular GMP training are conducted.
  • He/she approves the analysis specifications for the purchase of raw materials, finished goods, intermediate products and semi-finished.
  • He/she approves the methods of analysis of raw materials, finished products, intermediate and semi-finished products.
  • He/she approves the operating procedures of the activities related to GMP and product quality and the master of processing sheets of both the oral products of sterile products.
  • He/she ensures that the batch production record is approved before the release of the product.
  • He/she carries out extensive investigations related to OOS and OOT and makes the final decision on the management of such activities.
  • He/she makes sure that new suppliers are qualified as provided by QA-SOP-014.
  • He/she checks the execution of the annual monitoring of suppliers using quality data and reports collected during the year from QC.
  • He/she verifies the execution of the annual monitoring of quality of each finished products.
  • He/she ensures that the customer complaints are investigated and addressed, agree on the strategies for investigation, communicate the results to the CS (according QA-SOP-016).

 

Skills & qualifications:

  • University degree in chemistry and pharmaceutical technology, pharmacy, chemistry, industrial chemistry, biology, biotechnology.
  • Excellent English (read and spoken).
  • Experience in management QA team in the pharmaceutical industry for at least five years.
  • Communication, decision-making skills, ability to work in teams.

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

 

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