Senior Quality Technician (h/f/x)

Functieomschrijving

We looking for:

Quality Assurance

  The Senior Quality Technician is given the responsibility of providing support to QAM, act as deputy if needed     

  and provide back up to QC when it is required. The Senior Quality Technician has the responsibility to:

·          Maintain compliance to the requirements established in the Quality Management System

·          Ensure that the Quality Policy is communicated and understood within the facility

·          Participate in projects and programs to achieve and improve facility targets and objectives

·          Ensure that processes needed for the business unit and local Quality Management System are established, implemented and maintained

·          Ensure the required systems are operative and effective to assure customers of the desired quality

·          Participate in implementation of continual improvement attitude

·          Facilitate quality improvement tools (Stop & Fix events)

·          Maintain the contacts with the supplier/customer (viits, meetings, complaint handling, audits, …)

·          Represent the company in quality matters

·          Perform site assessments

·          Participate to customer audits and regulatory audits/inspections (AFMPS, FDA, BSI, AFSCA)

·          Coach and train the quality control/assurance department

·          Participate as a backup at Corporate QA-meetings

·          Provide to food regulatory agencies the quarterly listing or irradiated food products

·          Ensure review and approval of change in ERP system and documents in Customer Specification Change (CSC)

·          Ensure as a backup the role of documentary management system Merlin administrator

·          Coordinate in Deficiency (Deviation and Non-conformance) and CAPA handling within facility and Merlin system

·          Participate in Quality department assigned calibration

·          Participate to monthly facility Quality Oversight

·          Modify or review data in the follow up for Cobalt activity and irradiation codes document

 

Quality Control Back up

·          Assume the role of SADA KonnTRACK dosimetry system administrator and take charge of modifications when required

·          Ensure Process History and dosimeter review before irradiation

·          Ensure Process History Review after irradiation according to customer specification and good documentation practice

·          Ensure batch release, generate certificate of processing and sending documentation to customer

·          Send batch record of pharmaceutical customer to QP

·          Prepare frozen sample and analysis query for analysis laboratory

·          Participate in daily TIER meeting with Production, EHS and Maintenance departments

·          Approve or reject batch release

 

Functie-eisen

Knowledge/Education and Training:

·          Master in life Sciences (Biology, Chemistry, …)

Experience:

·          Relevant experience in Quality Assurance (at least 2 years)

·          Experience in the pharmaceutical medical device industry is an advantage

·          Fluent English (reading, speaking, writing)

Skills:

·          Fine organizational skills

·          Excellent communication skills on alla levels

·          Excellent relationship skills

·          Efficient, accurate, work according to plan

·          Flexible

·          Problem solving attitude

·          High profile commitment to quality

 

Arbeidsvoorwaarden

CDI

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