We are hiring a Quality Systems Specialist for a company in the pharmaceutical industry.Responsibilities: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 their 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 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 the company's policies, systems, and procedures (COPs, HBR, SOPs, and others). May qualify as internal GMP auditor.Minimum Requirements: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 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.
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