Durata; 6 mesi
Location Roma o Milano
Quality Assurance RP-QP Back up
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.
- 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.
- 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
- 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
- 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.
- 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.