INTRODUCTION. Ireland is a hub for pharmaceutical manufacturing activity. Due to business demands and/or nature of products being manufactured some pharmaceutical manufacturers have no other option but to manufacture 24/7. This research aimed to investigate the potential impacts of working irregular hours on human resources and quality in the Irish pharmaceutical industry. This research is important as it investigated factors influencing a pharmaceutical organisation’s operational excellence and quality management systems.

OBJECTIVES. This research consisted of two primary objectives. The first was to determine if working irregular hours has any effect in the area of human resources (namely staff morale and staff turnover intention) by surveying both employees that work regular hours and those that work irregular hours in the pharmaceutical industry. The second was to determine if working irregular hours has any effect in the area of quality (namely quality assurance (QA) and right first time (RFT) manufacturing) by interviewing key subject matter experts working in the pharmaceutical industry.

METHODS. To address the objective focusing on human resources quantitative research was used in the form of surveys. 84 people were surveyed: 44 shift workers (SWs) and 40 non-shift

workers (NSWs). Questions were focused on areas of staff morale and turnover intention. Raw data from survey respondents were analysed using Chi Square Tests of Independence to determine whether difference between group were independent of each other. The objective regarding quality within manufacturing was addressed through using qualitative research in the form of interviews. SMEs were interviewed with questions focusing on QA and RFT manufacturing. Thematic analysis was carried out on interviews which involved open coding followed by axial coding.

RESULTS. There was no significant difference between the groups for self-perceived levels of staff morale. There were however significant differences between groups when it came to other negative impacts associated with shift work. SWs were more likely to feel fatigued both during and after work, feel that their work negatively impacts their personal well-being, frequently feel under pressure in their role and feel emotionally agitated upon arriving home from work. It is possible that these negative implications of shift work may gradually impact employee morale over time by wearing people down. There were no significant differences between the groups and turnover intention. SWs were significantly more likely to admit that benefits associated with their job (i.e., compressed work week and financial bonus allowance) prevented them from quitting. An overall pattern was highlighted among the two groups that the rate of turnover intention increased over time.

The majority of interviewees believed that irregular working hours had no impact on QA. Interviewees emphasised that quality errors can occur at any time of day and stated that there are many possible factors at play when looking at quality errors with human root causes rather than fatigue alone. These can include but aren’t limited to; operator competency, complacency, mindfulness for task at hand and diligence to work. Similarly, the majority of interviewees believed that working shift work had no impact on the rate of RFT manufacturing. The general consensus of interviewees was that systems should be in place in order to catch mistakes before they occur and therefore set operators up for success.

CONCLUSION. Maintaining positive staff morale, low staff turnover, QA and RFT manufacturing are all important factors in ensuring operational excellence, productivity and products are produced to meet regulatory quality standards. This is why investigating potential factors which may impact these is important. Although some findings for this research thesis were insignificant, it helped highlight potential research areas for the future. These may include the impact of shift work on productivity or employee absenteeism all of which effect business functions. Looking closer at costs involved in investigating quality deviations would also be a worthwhile research topic.