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Quality Compliance Self-Inspection Sr Specialist

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Job ID R0032197 Date posted Jun. 15, 2021 Location Lessines, Belgium

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Job Description

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 5 years of experience required as a Quality Auditor in a regulated pharmaceutical
  • Prefer experience with supporting HA inspections, e.g. FDA, MoHs

Key Skills, Abilities, and Competencies:

  • 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
  • Must have excellent time management, organizational skills, verbal and written communication skills; able to efficiently communicate with cross- functional teams (locally and globally) and management
  • Project management capabilities
  • Demonstrate ability to lead / facilitate group discussions in a constructive and positive direction. 
  • Demonstrate effectiveness in ability to train others
  • Possess proficient computer skills and be experienced using MS Office Tools and Microsoft Teams.
  • Must be able to enter laboratory and manufacturing environment
  • Must be able to travel approximately 20% - international
  • Fluent in written and spoken English
  • Fluent in written and spoken French

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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