Quality Manager-AHK Tunisie Retour vers les opportunités

Mission / General Tasks and duties:

Your main tasks are as follows:

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

·         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

·         Training of subordinate personnel

·         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, conditionally 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 inter-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

·         Verify 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)

Qualification requirements:

Technical skills:

• Engineering diploma in Engineer in Quality or a related field from a reputable Tunisian university or equivalent
• Proven experience (5 to 7 years) in a similar position within an industrial firm in medical devices or pharmaceutical
• Good Knowledge of the requirements of ISO 9001 & ISO 13485 standards besides to good Knowledge of statistical methods used in quality assurance
• Good planning, organizational and excellent communication skills, with the ability to work in a group setting
• A proven experience in handling multiple concurrent tasks and meeting strict deadlines.
• Knowledge of MS Office and ERP Systems & processes
• Excellent command of French and English

Personal skills:

• Charismatic, positive and man/woman of action, your autonomy and rigor, your honesty and sense of responsibility besides your team spirit and sense of organization are part of your assets to succeed in your missions.