Description
A Global Biotech organisation currently requires an experienced QA Specialist to work at their facility in Ireland.The project primarily is for a new syringe filling line/packaging building and required alterations to existing buildings to support this.
Responsibilities:
The QA Associate will be a core member of the site Quality team supporting manufacturing operations and will serve as Quality point of contact for manufacturing.
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard.
•Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and client requirements, policies and procedures.
•Quality representative in Non Conformance triage using 5 Why or similar methodology
•Quality participation in Root Cause Analysis
•Review and approval of Non Conformances and CAPAs.
•Observation of interventions on aseptic fill line
•Perform quality walks of manufacturing area and manage actions
•Performs Quality Audits to ensure compliance with cGMPs
•Review of electronic and / or paper BR’s
•Compile QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses.
•Perform status changes and yields on the computer system and assign expiry date to products
•Prepare deviation reports for shipments as required
•Review and approve Master Batch Records
•Write, review and approve Standard Operating Procedures in accordance with client Policies
•Approves Systems validation protocols on behalf of QA.
•Prepare the agenda for Site Quality Review Team and submits Failure Investigations for Review / discussion - Prepare the SQRT minutes.
•Prepare Monthly Metrics.
•Maintain databases and other informational systems as necessary.
•Prepare deviation trend reports bi annually to establish any evident trends.
•Train new colleagues
•Comply with responsibilities as outlined in site Safety Statement and procedures.
•Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans.
•Is a champion for safe working practices and safety initiatives within their functional area.
•The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
Minimum Requirements
•Hold Third Level Qualification (Degree) in Science related discipline: Chemistry, Biology, Biotechnology Preferred Requirements
•Minimum of 3 years relevant experience in a Pharmaceutical / Biotechnology Quality role.
Possess key competencies as follows: Planning and Organisation, Problem Solving, Team Work, Flexibility, Coaching and Motivation, Role Model
•Good Interpersonal Skills
•Knowledge of aseptic manufacturing / experience
•Involvement in Root Cause Analysis / Non Conformance /Deviation investigations