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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Objectives and Responsibilities:

The function holder is responsible to lead and coach the QA Qualification team, to manage resources and budget and follow up on key performance indicators.

The main responsibility is to ensure compliance of qualification activities of process equipment, lab equipment, facilities & utilities. This includes system qualification documentation, calibration/certification records, change controls, and non conformances.

QA Qualification Operational activities:

• Assuring that the qualification status is maintained during life cycle of the systems in scope.

• Review and approval of qualification documents, Periodic System Quality Reviews, Validation Master Plans, Periodic Trend reports, calibration procedures, calibration rationales, calibration master forms and completed calibration records, maintenance procedures and master forms.

• Participate in system introduction and system change projects and assure quality and compliance aspects.

• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification related matters during audits.

• Ensuring that deviations related to systems (qualification, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.

• Pro-actively and continuously challenge the quality of the qualification processes to improve the performance of qualification and develop and implement improvements.

• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification.

Profile needed for this function

Knowledge

• 5 – 10 years’ experience in the Pharmaceutical industry.

• Thorough knowledge of pharmaceutical legislation, cGMP regulations and guidelines in the area of system qualification.

• Knowledge of the different systems used during the manufacturing process

• Strong analytical thinking, risk assessment, communication, managerial and leadership skills.

• Collaboration and teaming skills.

• Mindset for innovation and optimization

Degree

• Master Engineering, Pharmacy or equivalent degree

Languages

• Fluent in Dutch and English (written and spoken)

Required Skills:

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management