Description
RESPONSIBILITIES:The successful candidate will work within a small R&D team, leading QA/RA activities including but not limited to the following:
- Lead the Risk Management activities;
- Define and develop inspection methods;
- Prepare and execute GR&Rs;
- Support internal and external Process Validation activities;
- Support suppliers in the above activities;
- Conduct Regulatory assessments, including labelling and UDI;
- Support the preparation of the PTF and submission to regulatory bodies;
- Create the required documentation supporting the above activities.
REQUIREMENTS:
- Must have a third level qualification in Engineering/Quality/Science;
- Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab;
- Knowledge of Process Validation and Equipment Qualification;
- Must have excellent communication skills both oral and written;
- Able to interpret complex mechanical drawings;
- Knowledge of Risk Management techniques and related tools;
- Ability to work to and meet timelines essential;
- Excellent PC skills, with focus on MS Office;
- Attention to details and excellent analytical skills;
- Problem solving skills;
- Must be able to prioritize and organise tasks;
- Fast working and proactive.
ESSENTIAL EXPERIENCE:
- Must have a minimum of 2 years' experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector;
- A thorough working knowledge of quality systems such as ISO CFR Part 820 is essential. Knowledge of 21 CFR Part would be considered an advantage;
- Experience in Risk Management activities;
- Experience in inspection methods;
- Experience in Process Validation activities;
- Exposure to Regulatory processes;
DESIRABLE EXPERIENCE:
- Experience with CMM or other programmable inspection equipment;
- Experience in preparation of PFT for European and US submission;
- Experience in Medical Devices