- Reference: GJ44507
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Maintains site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
- 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.
- Responsible for review and approval of the following types of documents, relating to area functions:
– master records
– executed records
– failure investigations
– change control documents
– corrective/preventative action documents
– standard operating procedures
– validation protocols and summary reports
– QC data
– raw material tests
- Reviews procedures, policies and other instructional documents to ensure compliance with company policy and local and international regulatory requirements.
- Actively participate in continuous improvement initiatives.
- Participates in regulatory and customer audits.
- Collaborates with functional departments to resolve issues and maintain compliance.
- Identify gaps in systems and develop feasible plans for correction.
- Training of personnel on quality system processes.
Skills, Experience and Qualifications:
- Requires BSc/BEng in scientific discipline or related field with 8+ years of relevant work experience in pharmaceutical or related industry. Biologics manufacturing experience desired.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com