analyst.

Implements and manages 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. Maintains active and efficient communication channels along the several company sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides 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. Represents 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.
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.g., 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

- 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
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