Qualified Person & Quality Assurance Manager Montà

Qualified Person & Quality Assurance Manager
Montà
Piemonte, Montà

Qualified Person & Quality Assurance Manager Job ID 326060BR

Position Title Qualified Person & Quality Assurance Manager

Job Description Job Purpose

Release batches of pharmaceutical products for human use in accordance with the relevant

requirements and the European Union pharmaceutical regulation (Directive 2001/83/EC for

Medicinal products for human use).

Major Activities

- Release the batches of radiopharmaceuticals produced according to Directive 2001/83/EC

for Medicinal products for human use and National laws.

- Immediately communicate to competent authorities and to the person in charge of the

company every substantial irregularity detected in the product that has already been placed

on the market;

- Actively collaborate in the Competent Authorities inspections and effectuate the operations

required by them;

- Contributing to the definition of production programs, ensuring their realization in quality, in

time and in compliance with the Good Manufacturing Standards and current regulations;

- Certifythe production operations on suitable documentation and have responsibility for their

conservation/updating;

- Replace the Quality Control Manager in case of absence;

- Collaborate with the Quality Assurance department in maintaining the validation/qualification

status of the production site, equipment, training of personnel and management of quality

documentation.

- Work in shift with other QPs to supervise the production and quality control activities

- Collaborate with the Site Manager, the Quality Control Responsible and the Production

Responsible for the definition of shifts and presence of production and QC personnel

- Is available for the assessment of OOS and deviations that occurs Importante Azienda the batch

production and quality control

Minimum requirements Education:

Degree in Chemistry / Pharmaceutical Chemistry and

Technology / Pharmacy

Languages:

Good knowledge of English

Experience / Professional

requirements:

Ministerial Qualification as a Qualified Person.

Experience in the radiopharmaceutical field or in a

pharmaceutical company.

Division Oncology

Business Unit ADVANCED ACCELERATOR APPLICATIONS