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RRAA & QA Technician en Esparreguera, Barcelona.

10 Jun 2021 publicado por Professionals

24.000-30.000 €/año
tipo de contrato
jornada laboral
sector empresa
Química Farma
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técnico registros
Life Sciences
Pharma y Biotech - Medico
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our client

Important raw material manufacturer located near Barcelona requires the incorporation of a RRAA technician.

your functions

Assurance of compliance to SOPs, Change Control process, health authorities inspections/ CAPAs, regulatory workflows, follow up of deviations, quality complaints and recommends process improvements.
Attend and give support to the audits with customers, suppliers, regulatory agencies and internal audits, according to both ISO and GMP systems.
Provide guidance , support and direction to commercial teams with the requirements of the customers related to regulatory.
Provide all documentation related to the registration, homologations of our products, requested by customers. Responsible of quality questionnaires sent by customers.
Planification, elaboration, evaluation and maintenance of registration dossiers (ASMF, CEP, US-DMF) in e-CTD format. Registration and the submission of the dossiers to FDA, EDQM or any other Health Authority worldwide. Coordination and preparation of Answers to deficiencies letters received from Health Authorities.
Review and management of quality related registration documents
Provides guidance and interpretation of applicable guidelines and regulations to internal team.
Collaboration in the development and validation of APIs and excipients.
Collaborate with supplier¿s qualification management.

position requisites

        Education: Degree in Health Sciences (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent

·        Languages: Fluent English required (oral and written); knowledge of Spanish and other languages will be an asset.

Experience (years/area): Minimum: 2 Years of experience in chemical or pharmaceutical company
Experience implementing, and managing a quality management system in Regulatory Affairs.
Comprehensive knowledge of EMA, FDA, and ICH regulations, guidance, and polices (including GMPs) in pharmaceutical drug product manufacture or chemical drug substance manufacture.
Experience preparing for and managing regulatory authority inspections, including direct interactions with regulatory authorities.
Travel: willingness to travel up to 10%
Skills: self-motivated, open to new challenges, strong written and oral communication skills, strong interpersonal skills, ability to act independently
and objectively.

  • Formación: Grado: Grado en Farmacia
  • Conocimientos: LIMS
  • Experiencia: 2 años
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