QC Specialist – Change Control
This role will involve coordinating and maintaining the Change Control process on site to ensure that this key element of the Quality Management System operates continuously in a compliant manner while meeting ongoing business requirements.
You will also support other quality system elements such as Deviations, CAPA or QRM as required.
- Ensure compliance in all aspects of Quality for the manufacturing, quality systems, quality control, validation, facilities, and materials management.
- Administration and overseeing the Change Control process.
- Responsible for one or more of the site quality systems including but not limited to;
– 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
- Bachelors of Science or Engineering or related field.
- 3+ years experience in a pharmaceutical or regulated environment.
- Analytical, attention to detail and utmost ethical behaviour.
For more information or to apply for this position, please call Ben Forde on 061-512270