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Novartis Pharmaceuticals Quality Assurance / Qualified Person in Zaragoza, Spain

296273BR

Job ID:

296273BR

Job Description:

The QP/QA Manager is in charge of the maintenance at local level of the national quality management system as per GMP regulation and corporate guidelines as well as of all health regulated activities ensuring that all the relevant external and internal requirements are implemented, monitored for performance and adherence.

  • Ensures that each batch of medicinal product is produced and controlled in observance of the legal regulations and the conditions set at the time the drug marketing authorisation is granted.

  • Release the batches of radiopharmaceuticals produced at the pharmaceutical plant inaccording to Directive 2001/83/EC for Medicinal products for human use and National laws.

  • 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;

  • Participate in the compliance of the local quality system to the GMPs and corporate guidelines

  • Assure the respect of the GMPs and Health Authorities requirements at local level

  • Safeguarding of the quality of the medicinal products which have been manufactured by the radiopharmaceutical site

  • Assure the correct registration and archiving of the documentation at local level

  • Assure the execution of qualification, maintenance, calibration and revalidation programs at local level;

  • Act directly to the annual quality audit

  • Ensure that Out of specifications, Out of trends, deviations, CAPA, Change controls are addressed and recorded according to cGMP and SOPs

  • Participate to the self-inspections as per approved annual plan and to the external audits (Health Authorities, Certified Bodies, Supplier)

  • Complaint management at local level

  • Assure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities requirements

Position Title:

Quality Assurance / Qualified Person

Minimum requirements:

  • Scientific Degree (Preferred Pharmacist - qualification to Qualified Person)

  • English: fluent spoken and writing

  •  +2 years of experience in a Quality department

  • Strong affinity with and awareness of quality issues

  • Good organizational skills including attention to details

  • Knowledge of quality system (GMP)

  • Basic knowledge of regulatory requirements

  • Shows the appropriate sense of urgency around given tasks, work in team

Job Type:

Full Time

Company/Legal Entity:

AAA Ibérica S.L.U.

Country:

Spain

Work Location:

Zaragoza

Functional Area:

Quality

Division:

Oncology

Business Unit:

ADVANCED ACCELERATOR APPLICATIONS

Employment Type:

Regular

AAA Statement:

Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Shift Work:

Yes

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