Application Specialist: Filling at Aspen Pharma Group

Description

• To assume responsibility for the implementation, optimisation, and continuous process review against global standards of all sterile processing systems (formulation, filling, isolator, lyophilisation, and sterilization systems) within SVP, including capacity, OEE, GMP standards, yield and the ongoing validated state of all recipes and processes.
• Lead all technical and quality investigations and institute corrective action functions.
• Project manage any new automated system projects.

Requirements

Operational Activities

• Optimize all filling processes within SVP by validating, qualifying, and testing machines, and investigating quality concerns.
• Lead investigations, ensure corrective action is taken and provide support as required.
• Project manage new equipment projects and all associated activities from inception to close-out.
• Track performance against budget
• Coordinate and oversee activities of all cross functional departments.
• Manage supplier technical relationships.

Adherence to Standards

• Comply with all GMP/GLP standards and regulations.
• Identify, manage, eliminate, or mitigate any hazard or potential hazards.

Planning and Processes

• Provide technical and operational input when drafting plans.

Asset/Resource Management

• Determine resource needs of the team and/ or own area of work.

Technical/Functional Experience

• Apply advanced understanding of discipline / specialization.
• Analyse concepts and prepare procedures to operationalize new ideas.

Reporting / Reporting & Record Keeping

• Provide information for reports on weekly/monthly basis.
• Compile standardized reports and consolidate documents.

Supervision

• Provide staff with day-to-day direction and tasks.

Skills Required

Background/experience

• 4-6 years’ experience in a high speed multi format filling line manufacturing environment
• BSc Engineering or alternative degree in Pharmacy or Science

Specific job skills

• Project management
• Process, mechanical, electrical, and electronic engineering skills

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights
• Managing Performance
• Finalizing Outputs
• Creating Clarity