Production Quality Engineer

Authority:

-Supervise the ACQ and divide the tasks according to the needs

-Op testing activities and contain materials and products with immediate effect where critical deviations from regulatory

requirements and I or Fresenius Kabi's Quality Management system are noted

-Immediate notification to management on confirmed, reportable quality defects that become known

-Immediate notification to management on data integrity issues that become known

Responsibilities:

-Supervision of production related documentation incl. Batch documentation 

-Supervision over control, tests, and research 

-Elimination of quality errors during production 

-Leading of validations (manufacturing processes, equipment) and participation in qualifications

-Participation of Transfer of products from Blonie to Bir Drassen

-Training of subordinate personnel Cooperation with the Department of Production in the site as well as in Blonie

- Leading CAPA and Non-Conformities related to production

- Overseeing changes 

-Control, supervision and handling of the product, incompatible material

- Participate in audits Performing internal audits 

- Ensures the development of new products and projects

- Change the control of the factory and transfer of products from other factories and improving the product by interface with other functions as well as local corporate and ensuring that requirements customers are met 

-Developing and reviewing procedures and instructions as well as other quality documents and records 

-Identification of quality errors,Initiating CAPA activities

-Analyzing inconsistencies and deviations in their area of activity, developing and implementing CAPA

-Ensure compliance to the Corporate, GMP and hygiene standards throughout the plant in accordance with ISO 9001 and EN ISO 13485

-Control over raw materials, semi Finished products, conditionaily released ready products analysis of the correctness of measurement methods analyzing the needs of validation and qualification of measuring methods and control and measurement equipment

-Training of laboratory technicians and operators in the field of inteir operational material quality control, semi-finished and finished product, 

-Record keeping and records supervision over the correctness of conducting tests and tests: semi-finished products and finished products 

-Veriÿ that the work and control procedures exist and that they are applied correctly 

-Manage the verification of the ACQs on all instruments of work and control

-Ensuring the proper management of GDP and GMP working documents (documents of lots) as regards their good compilation and respects their internal procedures.

-Coordinate and ensure that quality controls on finished and semi-finished products are managed as intended in internal procedures supervision over control and measurement equipment 

-Manage requirements / consumables of all auxiliary materials relating to the travails of the ACQ in the workshop and laboratory            -Provide training within the company to staff supervision over non-compliant product, 

-Participation in RCA (assessment of cause and effect) monitoring changes in documentation, measuring instruments, measurement methods, production process and products Management-limit results (O.O. L)

Qualifications required:

-Diploma of Engineering in Quality or equivalent.

-minimum 5 years of experience in Quality Management

-Good knowledge of the requirements of ISO 9001 and 13485 standards besides the good knowledge od the statistical methods used in Quality assurance

-Fluent in French and English

-Good planning, Excellent communication, with the ability to work in a group setting

-Proven experience in handling multiple concurrent tasks and meeting strict deadlines