SME Visual Inspection

LocationLeverkusen, Germany


1. Scope
The following job description applies to the position, department and business unit as stated below:

2. Job Summary
 The successful candidate will have the opportunity to work in a Factory of the Future, and act as conduit between the customer and technical teams ensuring a seamless path to market for a wide range of products, including products for unmet medical needs. Reporting to Head of production management, this role will be responsible for VI process (manual and automatic) in the fill&finish production chain of drug product. This role acts as key position in providing support to management and floor operations with sure and profound knowledge of the process. The role requires excellent people and process management, planning and communication skills and acts as point of contact to the management, manufacturing staff and other departments. To be successful in this role, you must be very customer and goal focused, demonstrate excellent communication skills, including and demonstrate the ability to effectively interface with all levels across the organization. Be a strong team player with demonstrated ability to work on your own initiative, to get the things done.

Job Title: VI SME
Job Summary
Reporting to the Head of production management DP7, the VI SME will initially be responsible for supporting activities to ensure the facility and process design meets end user requirements. The VI SME will provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents as it relates to the VI process. In this the VI SME ensures compliance with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed. This role supports management in development of improved and new processing techniques in the various VI activities and provides technical support to production staff involved in the VI process. The VI SME is responsible and proficient in initiation, execution or support quality processes (Deviation, CAPA and CCR) in QMR TrackWise. In audits the VI SME answers process related inquiries into VI related topics.

Essential Duties and Responsibilities
Leadership & People Management
• You will part of a team of experts with different fields of expertise and responsibilities. In this you will bring your professional know-how into the team and devise as part of the team improvement of established processes or implementation of new processes.
• Work effectively with QA/QC, manufacturing, facilities and other support staff personnel
• Provide the VI process training to floor operation personnel
• Support or lead Tech transfer projects from receiving site.
• Responsible to support the training coordinator.
• Perform process mapping and process efficiency trending
• Determine KPI´ s

Safety Culture
• Designs processes according to EHS principles.
• Actively participates in risk assessments as required.

• Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
• Troubleshooting and technical support into process investigations.
• Facilitate deviation initiation , be responsible to investigate the issue, propose and execute CAPA.
• Facilitate/responsible of the change control process.
• Owner process related BR incl. improvement – support PDM at CCR´s and adjustment MBR
• Responsible for process related topics in audits
• Support validation and engineering project as production final user
• Support batch record review

Person Specification
Technical Competencies
• Professional experience in pharmaceutical production, at least 5 years required
• Vocational training on pharmaceuticals or chemistry or comparable training
• Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools (Standard Work, TPM, 5S, Method 1, 2 etc.)

• Familiar to sterile preparation production meeting cGMP
• Detailed knowledge on VI processes of parenteral drugs
• Knowledge in the areas of GMP and occupational safety
• Familiar to sterile preparation production meeting cGMP
• Detailed knowledge on FDA and EMA guidelines for visual inspection of parental drugs
• German and english in word and writing

• BS/MS with major in Biology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or person with equivalent experience.
• At least 5 years of professional experience at the pharmaceutical/medical/ biopharmaceutical industry at visual inspection processes for parenteral drugs in manual or automatic visual inspection processes are required.

Behavioral Competencies
• Team work capability with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude.
• Excellent verbal and written communication and presentation skills.
• Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organization.
• High degree of autonomy, initiative, dynamism and goal-oriented functioning
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• High degree of flexibility and resilience to answer to needs of a dynamic production process and demands of stakeholders (internal and external)
• Detail-oriented organizational skill

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