Quality Assurance Associate – Quality on the Shop Floor応募後で応募 求人ID R0047105 掲載日 09/10/2021 Location:Dublin, Ireland
The Quality Assurance Associate, Quality on the floor, involves being located within the manufacturing area to collaborate and support manufacturing in preventing, detecting and solving Quality challenges in real time. Also responsible for coordination of quality activities within the Quality Assurance group and duties as assigned by the Quality Assurance Executive. Key tasks and responsibilities are outlined below.
- Provide Quality oversight in compliance with the ‘Quality on the Shop Floor Program’ in real time, based in the manufacturing area.
- Ensure all aspects of the ‘Quality On the Shop Floor’ Procedure are implemented.
- Provide support relating to Quality issues in the Manufacturing area to solve quality events in real time.
- Assist in the investigations of quality events in real time (Triage process); identifying root cause and corrective and preventive actions.
- Verify identified activities are witnessed and recorded as required by applicable instruction and written procedure.
- Identify and solve noncompliant behaviours/practices
- Participate in Quality Risk Assessments
- Participate in the internal audit schedule
- Perform daily and weekly Gemba’s to always ensure inspection readiness
- Support the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Review of batch records
- Support activities relating to customer complaints, product returns and product recall
- Identify and promote Continuous Improvement opportunities e.g. identify and implement RFT processes
- Foster and implement a Culture of Quality Excellence
- Additional responsibilities may be assigned as necessary by the QA Executive or Manager.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
- Bachelor's degree in chemistry, biology or a related scientific discipline.
- Experience in quality in the pharmaceutical industry.
- Experience working in API, finished product pharmaceuticals/biologics, including quality assurance and/or manufacturing areas.
- Understanding of Quality cGMP's, regulatory filings and regulations
- Previous Quality experience based in the manufacturing area is a distinct advantage.
- Excellent verbal and written communication skills.
- Be self-motivated, flexible, organised and a good team player with the ability to prioritize own work based on departmental and site requirements.
- Work directly with other key departments to ensure compliance and productive working relationships.