Senior Quality Assurance Specialist - Lisbon (m/f)

Lisboa Indefinido

Atualizado 15/12/2022

  • Quality Assurance
  • Chemicals

Sobre o nosso cliente

Large multinational.

Descrição

  • Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always "audit ready"
  • Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities
  • Act as a catalyst for change and improvement in performance/quality
  • Provide an example of professionalism and leads the induction and training of new colleagues within the area
  • Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR
  • Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured
  • Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports
  • To authorize the release for sale of finished products (applicable to site without QP)
  • Prepare for and support internal and external site audits and inspections, leading regular reviews and periodically following-up action plans as necessary
  • Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits, taking a lead on the most complex situations
  • Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate
  • Close open deviations and propose CAPAs based on the outcome of periodic follow-ups
  • Prepare SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate
  • Approve IOPs, process master documentation and product specifications as required and appropriate.
  • Ensure that SOPs and IOPs are up to date, compliant and supports efficient production
  • Review regulatory documentation and co-ordination of site documentation to support regulatory requirements



Perfil ideal

  • University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
  • Typically requires 5-8 years of relevant experience within a QA GMP environment within the Pharmaceutical Industry (mandatory)
  • Experience of working in a GMP operational environment (mandatory)
  • Training and experience of GMP standards (mandatory)
  • Experience of working with Regulatory Affairs and a well-rounded knowledge of the function (mandatory)
  • Advanced knowledge of GMP practices with the ability to solve complex problems.
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package
  • Advanced documentation skills and attention to detail
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Vantagens

A great professional opportunity.

Pesquise mais Ofertas
Pedro Prata
Quote job ref
JN-102022-5781676

Resumo da Função

Setor
Engineering & Manufacturing
Subsetor
Químico/Processo
Indústria
Healthcare / Pharmaceutical
Localização
Lisboa
Tipo de contrato
Indefinido
Nome do Consultor
Pedro Prata
Referência da Oferta
JN-102022-5781676

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