Description:
The candidate must have a knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility as advantage. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal supervision.1
The individual will be responsible for the following:
- Supports Site Regulatory Inspections
- Reviews and/or approves nonconformance investigations and their associated documentation.
- Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
- Reviews and/or approves change control requests, implementation actions, and request closures.
- Reviews/Approves batch record documentation to progress to QP for shipment
- Coordinates and chairs meetings monitoring KPIs .
General scope of responsibilities:
- Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met
- Supports system qualification and process validation activities
- Review and approval of qualification/validation documentation.
- Assesses compliance systems on ongoing basis to see opportunities for process improvement.
Key competencies required:
- Collaboration and partnership
- Strategic problem solver
- Problem solving and attention to detail
- Results and performance driven
- Coaching and mentoring style
- Integrity, trustworthiness, and objectivity
- Customer focus
- Clear communication skills
- Adaptable and flexible
- Innovative
- Broad, facilitative style
Qualifications
Qualifications and Experience
ESSENTIAL:
- Third-level qualification (scientific/technical field required)
- A minimum of 3-5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry an advantage
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Proven knowledge and application of industry regulations as they apply to validation, including those of FDA, HPRA, EMEA and other authorities.
Desirable:
- Excellent social skills
- Ability to operate as part of a team is critical.
- Customer focus
- Innovative
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible