QA Validation Consultant - Change Control
A leading biotechnology company is currently looking for QA Validation Consultant to join their fantastic team in Limerick!!
This is a 12-month contract and an excellent opportunity to get into a very secure company during this difficult time.
The successful candidate will be coordinating and maintaining 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 include, but are not limited to, the following:
Responsible for ensuring compliance with all aspects of Quality for the Limerick 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;
- 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:
- BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 3+ years of related experience within the field
If you would like to learn more, send an email to firstname.lastname@example.org ring on 061 209 519 or apply.