Results

Transitioning temporary staff to provide stability

The challenge our client faced

In this case, our client was availing of a large number of temporary employees, all of whom were reaching the maximum tenure in the same timeframe. This was, of course, going to cause a huge disruption to operations. 

Delivering scientific laboratory management and COVID-19 testing solutions on-site when it was needed most

The challenge our client faced

The COVID-19 pandemic had an immediate impact on a lot of employees’ abilities to work on-site. Many of our clients did not have any policies or procedures in place, particularly in relation to personal protective equipment (PPE) or contact tracing, when it came to supporting those who needed to remain on-site and those who now had to work remotely. For one of our clients, putting operations on hold to wait for these policies to be developed was not an option. Luckily, they were able to turn to PSS^®.

Bring Innovative Solutions to Enhance Training Programmes

The challenge our client faced

The training programme our client operates to meet Good Manufacturing Practice (GMP) requirements takes three months. But due to staff turnover and a gap in trained resources, providing this training to new, on-site and temporary employees was proving a challenge in this timeframe. The cumulative effect of this was a negative impact on performance and quality.

Optimising output from full-time employees

The challenge our client faced

Our client was employing a mix of full-time and temporary employees. However, the constant turnover of temporary staff was having a negative impact on the morale of the full-time workers. Unable to fill open positions and increase headcount, the result was that the client was falling behind on expected timelines.

Replacing an external contracting service with on-site expertise

The challenge our client faced

A crucial element of Good Manufacturing Practice (GMP) is ensuring that all production and clean room areas are well maintained, fit for purpose, and meet strict standards of cleanliness. The issue our client had was that they were using an external contracting service to carry out aseptic cleaning of their manufacturing suites. Over time they began to experience serious quality compliance issues with this vendor, such as missed tasks and unresponsive service, which was resulting in downtime in those manufacturing suites.

Upscaling analytical skills in the Medical Device world

The challenge our client faced

In this case, our client did not have any R&D department and knowledge at its site and its network and wanted to upscale its employees’ skills in method development and validation.

Our expertise in setting up and qualifying GMP laboratories is brought to bear

The challenge our client faced

Our client had acquired an aseptic operations facility with freeze-dry product and liquid vial filling operations. This was to be expanded and include a Good Manufacturing Practice (GMP) microbiology laboratory. As the company had outsourced all of its previous microbiology work, there was limited experience within the client site in building and qualifying a microbiology laboratory.

Enabling clients to create a culture of care

The challenge our client faced

Our client, a large biopharmaceutical company, was employing temporary staff consistently on a long-term basis. With the maximum employment duration to mitigate co-employment risk BEING 18 months (with a 6-month extension) for temporary staff, these employees had to be released and a new group hired and trained. Our client grew uncomfortable with this arrangement because:

Why hire and manage your own staff when PSS® will for you?

The challenge our client faced

With low rates of unemployment in the scientific pool, there is strong competition for talent, with companies finding it difficult to retain staff. Our biopharmaceutical client had ongoing issues with recruiting and hiring QC analysts in a location with a small candidate pool. This was causing their backlog to grow, with pressure on timelines and costs mounting as staff turnover increased.

Manufacturing Science & Technology (MS&T) Group Developing Production Processes

The challenge our client faced

This Client’s Manufacturing Science & Technology (MS&T) group wanted to commercially scale up its production processes. A PSS® team was put in place to develop upstream, downstream, and analytical processes in support of developing and optimising production processes.

Ensuring Label and Packing Accuracy of Clinical Samples

The challenge our client faced

As the Client was increasing its number of clinical trial studies, it was struggling to find enough people to coordinate and label samples. In addition, it had been outsourcing responsibility for sample packaging and wanted to bring this work inhouse. 
PSS® was asked to manage all sample labeling, packaging, and shipping responsibilities.