Co-ordinates and maintains the site Change Control process to ensure that this key element of the Quality Management System continuously operates in a compliant manner while meeting ongoing business requirements. The role may also involve supporting other quality system elements such as Deviations, CAPA or QRM as required.
Essential Duties and Responsibilities
Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
Primarily responsible for administration and oversight of the Change Control process but may also be responsible for one or more of the site quality systems including but not limited to:
- Deviations
- CAPA
- Quality Risk Management
- Responsible for review and approval of associated change control documents, and other documents such as:
- Failure investigations
- corrective/preventative action documents
- Standard operating procedures
- Maintaining the electronic systems used for Change Control, Deviation Management and CAPA.
- Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
- Provision of monitoring and trending metrics associated with change control and other site quality systems
- Actively participate in continuous improvement initiatives.
- Participates in regulatory and customer audits.* Participates in quality risk assessments.
- Collaborates with functional departments to resolve issues and maintain compliance
- Identify gaps in systems and develop feasible plans for correction
- Training of personnel on change control and other quality system processes
Education and Experience
- Requires BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry.
- This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about our Clients unwavering commitment to combining good science & good business.
