Quality Technician PHARMACEUTICAL INDUSTRY 03122/1069

Descripción de la oferta

Descripción de la oferta:
·  Funciones y competencias
From Adecco Office, we are looking for quality technicia, for an important multinational in Madrid.

Responsibilities:

-Assuring compliance with established policies/procedures and Corporation and complies with all applicable governmental regulations (GMP, etc...)
-Responsible for evaluation and/or release of products with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
-Acting in conjunction with the External Site Quality Lead to the external manufacturers. Responsible for coordination, oversight, and communication on matters related to the GMP status of the external manufacturer.
-Tracing and monitoring operational and quality performance of the external party/partner.
-Performs change control assessments and approvals.
-Review and approves master batch records.
-Providing on-site guidance in the preparation of metrics, procedures, and guidelines where warranted.
-Provides guidance to the external partner on conducting investigations, customer complaints, etc. where warranted. Reviews and approves external partner deviation and complaint reports.
-Performs investigations and customer complaints as required
-Prepares Annual Product Quality Review.
-Closely collaborating with appropriate business/operations and technical areas to achieve objectives.
·  Nº de puestos vacantes
1
·  Se Ofrece
¿What do we offer?

-Contract with Adecco, for 9 months approximatly.
-Immediate incorporation.
-Schedule:
*From Monday to Thursday: 08:00/08:30 - 17:00/17:30.
*Friday: 08:00-14:00

Lugar de trabajo:
·  País
España
·  Área geográfica
Madrid

Delegación:
·  BL OFFICE MAD ESTE

Perfil buscado

Requisitos:
·  ESSENTIAL requirement:

-Bilingual level of English: 100% of the work is done in English (teleconferences, meetings, documentation ...)
-BS degree in Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedico/al Engineering (or equivalent).
-Minimum of 2 years experience in biotechnology or pharmaceutical industry with knowledge of quality systems, regulatory requirements and GMP.

Valuable requirements:

-Experience with biologics Quality Assurance.
-Experience with SAP based MRP platform and Trackwise change control
-German written and spoken.
-Possesses a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute the products.
-Receives guidance on policy issues as well as general and specific direction with regard to operations.