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Quality Assurance - Clinical III
Ref No.: 18-01133
Location: Lake Forest, Illinois
Start Date / End Date: 05/21/2018 to 03/20/2019


• Support Life Cycle Management group in remediation and compliance related activities focused on tech transfers to a new manufacturing site. This role will be working with the cross functional and supporting the regulatory team in the completion of different regulatory activities.

POSITION RESPONSIBILITIES

• Authoring Module 3 and defining regulatory strategy – work with cross functional team to author documentation and define strategy.
• Document and technical remediation – making sure that documents at initial site are correct. Making sure that documents at new manufacturing site are aligned. Able to weigh impact to regulatory strategy and determine impact assessment of changes related to manufacturing processes, methods, etc.
• Tech transfers – develop dossier sections to get sites qualified from global standards and able to perform impact assessments.
• Change control – perform analysis between registration and internal documentation. Process change controls and work on global regulatory strategies.

ORGANIZATIONAL RELATIONSHIPS

• This position will work and support global teams and articulate issues, impact and mitigation strategies.




EDUCATION AND EXPERIENCE

• 5+ years of Regulatory systems and process experience
• Bachelor’s degree

TECHNICAL SKILLS REQUIREMENTS

• Experience with API, drug product, manufacturing processes and validation, analytical methods and stability are highly preferred.
• eCTD and CTD documentation experience
• Strong and broad background with Pharmaceuticals. Pharma experience with Regulatory, R&D, Quality and Operations/Manufacturing are all beneficial. Parenteral liquid experience is ideal.
• Excellent written and verbal communication skills