Location
Co. Antrim, Northern Ireland | United Kingdom
Job description
Our client, an expanding Pharma site in Co Antrim is seeking applications from Quality professionals for the role of Quality Engineer. This a busy fast paced facility.
Duties will include:
- Liaise with customers and internal stakeholders to assist with the assessment and review of the QMS, manufacturing process, design transfer and specifications for products where the company is contract manufacturing for external customers.
- Assist Product and Process Engineering Departments with the content of design documents required for new product Introduction
- Assist Chemistry and Microbiology Departments with the content of protocols, procedures and reports
- Liaise with customers to ensure understanding of project timelines and deliverables
- To review planned changes or non-conformances to product design, specifications and the manufacture process and liaise with customers for approval as per applicable contractual agreements.
- Act as SME for quality manufacturing processes for customer, Regulatory Agency and Notified Body audits.
- To carry out and review the results of self-inspections/quality audits which appraise the effectiveness and applicability of the Quality System and to support regulatory and customer audits of the QMS.
- To write and review risk and gap assessments
- To carry out periodic reviews of products and processes in accordance with written procedures, report findings and contractual agreements.
- To assist in the review of validation protocols and reports for manufacturing, equipment and processes.
- To provide information for compilation of dossiers for regulatory support or customers.
- Provide support to project departments on the use of the electronic QMS
- Any other duties as may be reasonably required by your Manager from time to time
Applicants must possess:
- Degree in a relevant science / engineering subject and or 5 years’ experience in a quality related role
- Minimum of 3 years work experience in a GMP Manufacturing environment
- Have a good working knowledge of relevant GMP regulations and requirements
- Auditor – experience in auditing to GMP standards and being audited to GMP standards
- Risk Management experience including root cause analysis, FMEA
- Supervisory skills/experience
Job tags
Salary
