Quality Compliance Self-Inspection Specialist

Jobinhalt

Great opportunity as Quality Compliance Self-Inspection Specialist for TAKEDA Belgium in Lessines

Summary of Primary Duties:

The Quality Compliance Self-Inspection Sr Specialist is responsible for the development and execution of self-inspection program, and oversight of related corrective action plans and internal education as necessary.

In conjunction with Compliance leadership, he/she will develop an annual auditing and monitoring plan.

He/she will conduct auditing (locally and across the Manufacturing sites of the company) and monitoring activities and review necessary documents to determine compliance with regulations and/or policies and procedures. He/she will prepare written reports of audit results including recommendations for improvement and investigations as necessary.

He/she will oversee the Self-Inspection CAPA program. Track the CAPA investigations and ensure they are being completed on time with appropriately documented investigations, corrective action plans, effectiveness checks, etc.

He/she will evaluate the adequacy of the provided evidence against the approved Audit Action Plan.

The Quality Compliance Self-Inspection Sr Specialist will participate actively to the site compliance program including inspection readiness program, GMP/Compliance walkthroughs, external and internal audits, gap assessments, and delivery of continued education on GMP and Compliance; the preparation and maintenance of key quality indicators and site metrics for the appropriate communication to Site Leadership and Global teams.

Responsibilities:

• Schedule, prepare, conduct, document, and follow-up of assigned GxP walkthroughs, self-inspections in accordance with Takeda corporate standards
• Provide guidance on mitigation/resolution
• Maintain inspection readiness plan, conduct inspection readiness training, and coordinate support staff
• Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements and by delivering continued education on GMP and Compliance
• Drive Inspection readiness projects and assist other areas within the facility in understanding FDA, EU, and other quality requirements
• Have a key role during inspections (e.g. preparation room coordinator, inspection liaison, and/or inspection host during inspections)
• Compile and/or review various key quality indicator trends/metric data at defined frequencies. Prepare and report trend and metric data via management review operating mechanisms

Education and Experience Requirements:

• High school / university degree in biology, biochemistry, industrial or chemical engineering
• Minimum 3 years of experience required as a Quality Auditor in a regulated pharmaceutical
• Prefer experience with supporting HA inspections, e.g. FDA, MoHs
• Strong knowledge of regulatory regulations, cGMP, and Quality Systems is required
• Be a self-driven individual who requires minimal supervision
• Ability to handle audit situations and interaction in a tactful, professional and effective manner
• Excellent time management, organizational skills, verbal and written communication skills;
• Demonstrate ability to lead / facilitate group discussions in a constructive and positive direction. Demonstrate effectiveness in ability to train others
• MS Office Tools and Microsoft Teams.
• Fluent in written and spoken English AND French

• Must be able to travel approximately 20% - international

Offre

We propose a CDI contract / permanent contract in one of the largest and leading companies in the Biopharmaceutical Sector : TAKEDA.

Here the salary benefits to work for Baxter as such Quality Compliance Self Inspection Specialist :

• Attractive salary
• Lunch voucher
• Travel cost refund (go & back)
• Insurances

Interested ?

Send quickly your application !