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.
- 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 50% - international
- Fluent in written and spoken English
- Fluent in written and spoken French
BEL - Lessines