QUALITY SYSTEMS SPECIALIST
Descrição da oferta de emprego
Responsabilidades - Promote high-quality work within the team and a mindset of continuous improvement; - Advise Team Members when unconformities with Quality or, Regulatory Systems and Tools have been identified and promote corrective actions; - Propose new procedures and or policies according to the requirements applicable to the company business and strategy and review existing procedures; - Prepare Quality and/or Regulatory Systems and Tools related documentation and training; - Participate in Audits/inspections (Internal and of Health Authorities); - Perform other Corporate key activities, such as delivering Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.
., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support etc.); - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner; - Propose improvements to the area as appropriate and solve problems; - Lead initiatives within group or department, ensuring plan definition and timely execution; - Make quality and timely decisions within the Quality and/or Regulatory Systems’ tasks under her / his responsibility; - Gather relevant data to inform the decision makers regarding complex issues; - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice; - Execute professional activities in compliance with applicable Quality, Regulatory and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company´s policies, systems and procedures (COPs, HBR, SOPs and others) May qualify as internal GMP auditor.
Requisitos - University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field (mandatory); - Typically requires 3-5 years of relevant experience in operational areas (e.
., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering), preferably within the Pharmaceutical Industry; - Strong understanding and knowledge of Quality and/or Regulatory requirements, cGMP´s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards as applicable with the ability to solve complex problems; - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down; - Fluency in English is a requirement; - Computer literate with good working knowledge of the MS Office package.
Detalhes da oferta
- Clan by Multipessoal
- Em todo Portugal
- Indeterminado - Indeterminado
- Indeterminado
- 23/09/2024
- 22/12/2024
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