Specialist Compliance, Manufacturing

Conteúdo do emprego

Summary

The compliance specialist is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control, training and batch record review.

The compliance specialist will support cGMP and site quality compliance goals within manufacturing department. He/She will also manage continuous improvements and efficiency projects

Duties And Responsabilities

• Ensure that the systems are ready for inspection at all time
• Raise, investigate, assess and close Deviation within timelines
• Define and plan CAPA to avoid recurrence and allow process improvement.
• Define and plan effectiveness check
• Manage Change Controls Process
• Define and maintain KPI for manufacturing support group regarding quality and operational performance
• Act as SME during Heath Authorities inspection by presenting RA, Deviations, Investigations, CCP and CAPAs
• Develop and maintains business KPI’s and proposes/supports continuous improvements
• Author, review and approve SOP/WI or any manufacturing supporting document
• Act as a mentor to USP/DSP manufacturing team members and lead by example to ensure integration of good manufacturing practices
• Coach and train Manufacturing Staff to GMP guidelines
• Proactively propose problem resolution to process and USP/DSP equipment
• Review and support the review of executed batch report (exception review)
• Implement quality compliance initiatives in the department in collaboration with QA
• Coach and support other team members for quality compliance matters (such as deviation and changes management)
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Delegate to: Manager process support
  

Requirements

• BSc, Master or Engineering Degree in Pharma/Biotech engineering
• Relevant experience in biotech industry related to cGMP drug manufacturing and quality.
• Direct experience in FMEA, root cause analysis, and associated quality assessment tools
• Typically minimum 3-5 years of experience
• Ability to work in a fast paced – high regulated environment
• French and English (Fluent)
• Team work oriented mindset
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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