職位描述
Main Responsibilities:
1. To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
2. To perform all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices
3. To ensure that all Quality Systems external communications are of an acceptable standard to meet customer needs and facilitate improvement where necessary.
4. To provide Quality Systems support to operations, both Hull & PFG’s to ensure timely closure of quality activities and drive continual improvements.
5. To collate, interpret and report data from multiple sources to support business reporting activities.
6.To input and manage data within existing Quality System databases.
7. To present Quality system processes and data to external regulatory bodies and senior management as required.
8. To ensure efficient and effective Quality system processes are operating site wide through the development and implementation of procedures, training and guidance.
9. To support Corrective Action & Preventative Action (CAPA), by escalating adverse trends and ensuring all specified actions are closed in a timely manner within the Quality Systems team.
10. To assist as required in the creation and management of departmental measures which monitor section performance and drive continuous improvement.
11. Assist, where necessary, in any potential or actual Field Safety Corrective Actions.
12.To perform customer complaint investigations, evaluating and documenting the root cause of the failure in line with Global policies and procedures and pre-defined timescales.
You will need:
1. An HNC or equivalent qualification with at least 3 years’ experience in a Quality/Technical Engineering related role
2. Good working knowledge of company products, processes, procedures and personnel
3. Experience working within Quality Assurance, preferably within Medical Device / Pharmaceutical Industry preferred.
4. Awareness / understanding of the Medical Device Directive, GMP, GDP, ISO 9001, ISO 13485, 21 CFR Part 820 preferred.
5. Strong analytical and good communication skills are essential together with the ability to manage personal workload to ensure high standards are maintained.
6. Trained auditor desirable
7. Awareness / understanding of the impact of the department on the business.
8. Knowledge of the potential for product liability, alleged adverse incidents and potential Field Safety Corrective Actions.
9. Understanding of basic inspection techniques and problem solving skills
10. Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.
