Quality Systems Specialist - **NEW

• Support organisation in management of a Deviation system.
• Facilitating cross functional meetings and providing guidance and consultation to deviation stakeholders.
• Collaborating with other departments on completion of investigations and root cause analysis.
• Supporting in establishment and implementation of effective corrective/preventative actions
• Support organisation in management of a CAPA system.
• Management of CAPAs that derive from various processes: deviations, internal audits etc.
• Facilitating cross functional meetings and providing guidance and consultation to CAPA owners.
• Collaborating with other departments on completion of CAPAs

• Pharmacist or Engineer with master’s degree in quality, Regulatory or scientific topic.
• A minimum of 2 + years of experience in pharmaceutical or biotechnology industries. Relevant experience in either quality, regulatory, manufacturing, or development.
• Understanding of GxPs, quality systems and regulations (EU, FDA, ICH).
• Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required.
• Experience with Quality Management Systems heavily preferred.
• Ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
• Aptitude to comprehend, analyse and interpret process and systems information, technical procedures, reports, and regulations to make decisions in GXP environment.
• Excellent interpersonal, written, and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning to be responsive, gain trust and build strategic relationships.
• Ability to work in an international matrix environment.
• Fluent English skills required, French or other languages will be a plus.

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