Under general direction, support, coordinate, execute and follow-up, but not limited to:
- All manufacturing activities related to the correct use of the SA P system.
- SAP Manufacturing process investigations.
- General support for manufacturing goals completion within the quality system and regulatory requirements.
Necessary Duties and Responsibilities include the following:
- Report and Monitoring acts or unsafe conditions.
- Perform the duties following the guidelines of the Quality Management System.
- Behave according to the Company Ethical Charter.
- Support Manufacturing Operators to assure the correct use of the SAP system.
- Support Manufacturing Supervisors with the resolutions of events related to SAP.
- Correct wrong SAP transactions in coordination with the Superusers Production Supervisor.
- Use of Global service desk and Application Management Service platforms to escalate issues.
- Coordinate and support operators SAP training and qualification if applicable.
- Provide Manufacturing SAP information or generate reports as necessary.
- Perform manufacturing cycle counts.
- Control and adjust manufacturing inventories in coordination with the supervisor and according to the company policies.
- Execute and Support SAP system validations.
- Perform the Manufacturing Change orders related to SAP system, if necessary.
- Perform and document the investigations of process deviations or non- conforming material to provide a disposition according to quality guidelines, if necessary.
- Propose any other projects to support the achievement of company strategic objectives.
- Perform any other activity that the Center of Expertise Production Supervisor considers necessary.
Relationships and Roles:
- Reports direct to Superusers Production Supervisor.
- Coordinate and work along with Manufacturing Supervisor, Leader and Operators.
Job Specifications:
- High School Degree.
- A minimum of 1 year of experience working in production positions in medical industry or 3 years in other industries.
- Technical level or university education of IT or Engineering major is a plus.
- Knowledge of ISO 9001, ISO 13485, FDA, CE Mark standards and GMP´s.
- Experience in controlled production environments.
- Experience in training programs related to manufacturing of medical devices processes.
- Advance Computer knowledge is required: spread sheets, word processor, power point, outlook and basic computer configuration.
- Basic to Intermediate speaking and writing English skills.
- SAP or similar ERP systems.
- Good communication skills both oral and written.
- Analytical thinking.
- Customer Oriented.
- Ability to handle confidential information.
- Multitasking abilities.
- Oriented to results.
- Ability to prioritize and manage concurrent projects.
