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Head of Quality (M/F)

ID:
8768773
Data:
28-07-2020
Empresa:
Intelac Temporária, ETT, Lda
País:
Portugal
Distrito:
Lisboa
Localidade:
Sintra
Categoria(s):
Higiene e Segurança/Qualidade
Intervalo salarial:
Informação exclusiva JobMatch

Descrição da Empresa

A Intelac Temporária é uma empresa na vertente de Recursos Humanos que atua em quatro áreas de negócio distintas: • Trabalho Temporário •Recrutamento e Seleção •Outsourcing •Jobs International Estamos localizados em Oeiras e operamos em toda a área metropolitana de Lisboa desde 1998 com o alvará nº 235 de 19/06/1998.

Registada há 6 anos no SAPO Emprego 114 ofertas anunciadas nos últimos 6 meses

Detalhe da Função

Intelac recruits for Pharmaceutical Industry

 Head of Quality (M/F) - SINTRA

 Main Responsabilities and Activities:

 Oversee and manage all GxP Quality functions (QA and QC)

  • Ensure that Quality processes and competencies are in place to drive a culture of compliance and collaboration
  • Oversee development and improvement of QC laboratory systems to ensure products are tested in accordance with established specifications, regulatory guidance and company polices;
  • Lead preparedness for and conduct of health authority inspections. Establish and maintain positive relationship with INFARMED and other regulatory authorities
  • Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures with internal and outsourced activities
  • Assure that manufacturing activities and product testing are appropriate, are conducted in compliance with company policies and procedures, and that documentation is accessible and ensures traceability/accountability
  • Ensure that Quality Agreements are complete, approved and updated at appropriate intervals
  • Support planning, scheduling and performing GxP audits/inspections (internal and external) to assure adherence to company SOPs and any applicable regulatory requirements
  • Oversee risk assessments to determine level of compliance risk. Lead implementation of appropriate risk mitigation strategies
  • Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations
  • Oversight of compliant program activities
  • Leadership of Quality governance committees to review metrics, dashboards and compliance trends
  • Oversight of the trends within production (i.e. Change Controls, CAPAs, Deviations, Complaints, etc.) to manage risk and improvements
  • Support development of company training programs for GxP-related procedures, practices and system requirements
  • Manage process improvements for quality information management system
  • Remain current with quality management trends.
  • Prepare and manage department operating plans and budgets
  • Oversee hiring of staff as well as external consultants
  • Recruit, train and mentor staff
  • Perform investigatory and disciplinary meetings as required and directed by the CEO
  • Develop a culture of reporting within the Quality department
  • Prepare monthly reports and submit to the CEO in a timely manner
  • Perform all reasonable duties as directed by the CEO

 

Required:

  • Degree in Pharmaceutical Sciences, Chemical Engineering or equivalent degree.
  • Leadership and organizational skills
  • Good written and verbal communication skills to interact with the regulatory authorities and other parties
  • Solid knowledge of Good Manufacturing Practices (GMP)
  • Solid knowledge of cGMP and Active Pharmaceutical Ingredient manufacturing.
  • Leadership and organizational skills, good written and verbal communication skills to interact with the different site sectors and collaborators.
  • Experience in a QA supervisory role, in a GMP environment for a minimum 3 years.
  • Preferable, previous experience in Production and/or QC roles
  • Experience in leading quality investigations
  • Solid knowledge of quality risk assessment methodologies (e.g. ICH Q9 Quality Risk Assessment)
  • Experience in executing Audits (auditor title will be a must).
  • Excellent English both written and spoken.

 

Offered:

  • Full time position;
  • Remuneration adjusted to function and experience;
  • Work environment of excellence, focusing on quality;
  • Investment in training and personal development;
  • Good career prospects

 

Please send your application with reference CA_ HeadQuality confirming your consent to the processing of the data contained in that CV for the purposes of this recruitment process or others according to your profile, within 2 years. If you do not consent, we will not be able to consider your process. You can consult our Privacy Policy at intelac.pt/site/politica-de-privacidade/

Pesquise também por: qualidade

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