350692BR
Aug 11, 2022
Portugal

Job Description

 Releases the manufactured batches according to the regulations.
 Ensures that every batch of a drug is produced and controlled with respect to the
regulations and conditions applied to the site.
 Controls that, in the case of medicinal which come from countries not in the European
union, each imported lot is subject to a semi-quantitative analysis and any other
testing necessary to guarantee the quality of the special medicine according to the
conditions required for the authorization for the sale of the pharmaceutical.
 Guarantees on appropriate documents that the operations were performed as
documented.
 Is responsible for the archiving of the documents according to the internal procedure
and is obligated to show them on request by the health authority.
 Immediately communicates all irregularities related to the product to the competent
health authorities and to the quality site/country head.
 Active collaborate in competent authorities’ inspections and performs the operations
resulting from these inspections.
 Remains vigilant on the general hygiene conditions of the areas in his command.
 Contributes to the definition of production programs and ensures the realization of
quality, respecting the Good Manufacturing Practices and else regulations.
 Guarantees that the production operations are documented and is responsible for
their archiving and updates
 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;
 Approve the APR achievement according to the calendar;
 Participate to the self-inspections and external audits as per approved annual plan
 Assure, at local level, the execution of the staff GMP training and the respect of the
training annual plan;
 Assure the application of the recall procedure in case of critical issues impacting the
products as per GMPs and Health Authorities requirements

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education: A qualified person shall be in possession of a diploma,
certificate or other evidence of formal qualifications
awarded on completion of a university course of study,
or a course recognized as equivalent by the Member
State concerned, extending over a period of at least
four years of theoretical and practical study in one of
the following scientific disciplines: pharmacy, medicine,
veterinary medicine, chemistry, pharmaceutical
chemistry and technology, biology.
However, the minimum duration of the university
course may be three and a half years where the course
is followed by a period of theoretical and practical
training of a minimum duration of one year and
including a training period of at least six months in a
pharmacy open to the public, corroborated by an
examination at university level. Where two university
courses or two courses recognized by the State as
equivalent co-exist in a Member State and where one
of these extends over four years and the other over
three years, the three-year course leading to a
diploma, certificate or other evidence of formal
qualifications awarded on completion of a university
course or its recognized equivalent shall be considered
to fulffil the condition of duration referred to in the
second subparagraph in so far as the diplomas,
certificates or other evidence of formal qualifications
awarded on completion of both courses are recognized as equivalent by the State in question.

Experience / Professional
requirements:

 Recognized by the Portuguese Organization ( Ordem dos Farmacêuticos) to work as a QP
 The qualified person shall have acquired practical
experience over at least two years, in one or more
undertakings which are authorized to manufacture
medicinal products, in the activities of qualitative
analysis of medicinal products, of quantitative analysis
of active substances and of the testing and checking
necessary to ensure the quality of medicinal products.
The duration of practical experience may be reduced
by one year where a university course lasts for at least
five years and by a year and a half where the course
lasts for at least six years.
 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
 Pharmaceutical Industry Speciality by
the Portuguese Pharmaceutical Society


Languages: Portuguese
English: fluent spoken and writing
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Portugal
Porto
Quality
Full Time
Regular
No
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350692BR

QA Specialist/Deputy QP

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