Quality Assurance Specialist
Há 1 mês
Job Description:
In partnership with our client, a prestigious reference company in the pharmaceutical sector, we are seeking a highly skilled Quality Assurance Specialist.
Main Responsibilities:
Implement and manage the required guidelines and cGMPs for the company, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company's strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintain active and efficient communication channels along the several company sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluate, advise and provide services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represent the company through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for company and customer products; and within professional associations, industry/trade groups.
Key Skills:
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.g., 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. Fluency in English is a requirement. Computer literate with good working knowledge of the MS Office package.
What We Offer:
Temporary Worker, Shift allowance, Local - Loures.
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