Qualified Person

Novartis; Ivrea; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company located in Piemonte, Italy is seeking a Qualified Person to independently supervise manufacturing processes and ensure compliance with quality standards. The ideal candidate will have a degree in Pharmacy or Chemistry and previous experience in a pharmaceutical environment, holding authorization as a Qualified Person. Fluency in Italian and English is required. This full-time position offers an opportunity to collaborate and improve manufacturing processes aligned with regulatory requirements.

Competenze

• Previous experience in a pharmaceutical manufacturing environment.
• Authorization as Qualified Person according to local law.
• Strong affinity with quality and awareness of quality issues.

Mansioni

• Supervise manufacturing processes and control testing.
• Assess and release manufactured products according to legislation.
• Communicate irregularities to national Health Authority.

Conoscenze

Quality Assurance

GMP Procedures

Fluent in Italian

Fluent in English

Technological Expertise

Formazione

Degree in Pharmacy, CTF or Chemistry

Descrizione del lavoro

Job Description Summary

Independently supervise without any interference of third persons manufacturing processes and control testing of the site related to the drug manufacturing license operating as Qualified Person according to the local law (Article 52 of the Legislative Decree n. 219 of April 24th 2006 from EU directive 2001 / 83 / CE and following modifications). With respect to the quality of the medicinal products assurance of compliance to the National Medicines Law and other applicable regulations and together with the Site Quality Head and Site Manager maintaining an effective implementation monitoring and maintenance of a GMP-compliant quality system.

As Quality Assurance it is required to support all GMP relevant tasks / issues (operational and strategic) by ensuring compliance according to the internal quality standards relevant regulatory requirements filed product quality standards and SOPs in place.

Job Description

Major accountabilities :

Guarantee and certify that each batch of medicines is produced and checked in compliance with the law and the conditions imposed in the marketing authorization.

Assessment and release of manufactured medicinal products in accordance with national legislation.

Guarantee that the documentation attesting the suitability of each product lot is available and can be shown at the request of the health authority.

Collaborate in the approval of deviation investigations.

Make sure that the batch record of the released batch is stored correctly and can be exhibited at the request of the health authority.

Communicate immediately to the national Health Authority (AIFA) and to the Management any substantial irregularity detected in the product that has already been placed on the market.

Work in collaboration with Quality Control and Production departments in the activities related to the manufactured batches.

Identify and propose technological and organizational interventions aimed at improving manufacturing processes in terms of quality productivity and costs and the optimization of resources.

Collaborate with the Function Managers in order to guarantee the correctness of the Quality Management System.

Management od deviations complaints change control and CAPA.

Essential requirements :

Degree in Pharmacy CTF or Chemistry.

Previous experience in the role within a pharmaceutical manufacturing environment ( Authorized Qualified Person certificate according to Legislative Decree n. 219 of April 24th 2006).

Strong affinity with quality and awareness of quality issues.

Open and clear collaboration and communication to make sure the daily production operation runs smoothly and safely.

Fluent in Italian and English.

Skills Desired

Continued Learning Dealing With Ambiguity Employee Performance Evaluations Gmp Procedures People Management Qa (Quality Assurance) Quality Control (Qc) Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence

Key Skills

Accounts Management,Facilities Management,Law Enforcement,Administration Support,ERP,Development

Employment Type : Full-Time

Experience : years

Vacancy : 1