Summary of Primary Duties:
The Quality Compliance Specialist will lead, and/or 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.
He/she will have a key role during inspections (e.g. preparation room coordinator, inspection liaison, and/or inspection host during inspections). He/she will perform site self-inspections and will be responsible for leading various projects internal and/or external to the department. The person is responsible for collaborating within the network to share inspection knowledge and participate to global projects, as well as to drive process improvements at the site level.
- Drive Inspection readiness projects and assist other areas within the facility in understanding FDA, EU, and other quality requirements
- Conduct inspection readiness and inspection management training and coaching; support and coach business on compliant processes
- Have a key role during inspections (e.g. preparation room coordinator, inspection liaison, and/or inspection host during inspections)
- Conduct GMP/Compliance walkthroughs, self-inspections to identify potential gaps or risks and provide guidance on mitigation/resolution
- Compile and/or review various key quality indicator trends/metric data at defined frequencies. Prepares and reports trend and metric data via management review operating mechanisms
- 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
- Support the Product Quality Reviews writing
Education and Experience Requirements:
- High school / university degree in biology, biochemistry, industrial or chemical engineering
- Prefer experience with supporting HA inspections, e.g FDA, MoHs
- At least five years auditing experience within the pharmaceutical industry
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
- Demonstrates 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.
- The position requires a combination of sedentary work and walking around observing conditions in the facility - must be able to enter laboratory and manufacturing environment
- Fluent in written and spoken English
- Fluent in written and spoken French
BEL - Lessines