Logistics/Healthcare – Quality Assurance RP-QP Back up

Durata; 6 mesi

Location Roma o Milano

Quality Assurance RP-QP Back up

KEY RESPONSIBILITIES

MANAGEMENT AND MAINTENANCE OF QUALITY DOCUMENTS AND PROCEDURES

  • Own/ write/ review Procedures, Work Instructions, and technical documents
  • Performs training programs in SOPs, work instructions and regulatory topics
  • Management of Non conformities
  • Follows up the CAPA actions in order to get them implemented on time
  • Scheduling, preparation and perform internal and external audits
  • Management of Change Controls
  • Ensure equipment calibration and maintenance program are met
  • Under the direction of the Healthcare Compliance (QA) Management, conducts Management Reviews
  • Provide support for validation activities
  • Collaborates in the reception of corporate audits and regulatory agencies audits.
  • Collaborate to ensure that the vendors are properly approved.
  • Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards.

GDP REGULATORY

  • Collaborates with the Responsible Person  to ensure that the recall process is properly managed
  • Collaborates with the Responsible Person to ensure that the return process are properly managed
  • Collaborates with the Responsible Person to ensure that compliance of the legislation related to narcotics and psychotropic are met
  • Supervises the temperature monitoring through all steps.
  • Assures that all the processes regarding the warehouse activity (storage, vehicles inspection, products inspection, picking & Packing, etc) are performed according to approved procedures or work instructions and according the GDP and GMP regulations.

GMP REGULATORY

  • Collaborate with the Qualified Person to ensure that GMP guidelines (annex 16EU) are respected
  • Collaborate with the Qualified Person to ensure that all the checks and tests, including sampling or additional checks have been performed.
  • Collaborate with the Qualified Person to ensure that all necessary documentation regarding production and quality control, has been developed and approved.
  • Collaborate with the Qualified Person to ensure that all quality inspections for pre-production, production and post-production have been carried out (e.g. line clearances, control of material to use, etc)
  • Reviews of batch records.

KNOWLEDGE AND EXPERIENCE

Education level:

  • Master degree and work experience to be qualified as QP
  • Professional authorization according with Italian legislation (Iscrizione all’albo)
  • Good knowledge of English.
  • Good knowledge of Microsoft Office.
  • Good knowledge of Outlook

Specialized Knowledge:

  • Experience with ISO 9001 and/or ISO 13485
  • Knowledge of GMP and GDP.
  • Required mínimum 2 years of experience in companies such as manufacturer/ laboratories/ distributors of pharmaceutical products.

Skills:

  • Ability to prioritize decisions.
  • Good organizational skills   
  • Identify potential gaps in the processes and make recommendations for possible improvements.
  • Implementation of new processes having a quality critical impact on the business.
  • Flexible in working hours.
  • Knowledge of electronic Quality Management System and/or Warehouse Management System (WMS, GWS etc.) is an advantage.
Candidati!

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