Job Description

Quality Systems Specialist

An opportunity has arisen for a Quality Specialist to support the Quality Systems activities in both the Drug Substance and Drug Product facilities within a leading Biopharma Multinational based in the North Munster region.

Key Responsibilities:

* Provide leadership, regarding the validation standards required for Process, Cleaning, Water and Equipment.

* Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.

* Laboratory QA oversight

* Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships.

* Annual Review System Management

* Creation, review and approval of Site Quality documentation including

* Review and approve Supplier Change Evaluation documentation.

* Investigate Supplier and Customer complaints

* Filing & Licence maintenance and Regulatory Requests follow ups

* Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings

* Support the internal GMP walk-down and scheduled audits programme

Qualifications and Experience

* Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field

* 3+ Years relevant experience within the pharma/biotech industry.

* Strong Communication skills both written and oral

* Pro-active approach

* Planning and scheduling experience

* Customer service skills

* Interpersonal Skills