Develop and provide effective TrustGrade Biotech Supply Chain solutions, serving our Customer’s compliance requirements, in a principled, sustainable and caring family tradition.
Our in-house experience:
At McArdle Skeath we have a very experienced in-house team of subject matter experts. The SME’s roles are led by the management team, they are complementary to our supply chain solutions offering. Our experience enables us to engage, develop and provide tailored solutions for our customers. The core SME are contained within Construction & Project Management; QA and Lean Production capabilities. Below we have set out some examples of how we have used each of these capacities.
Lean Production Capabilities:
Our experienced operational team handle over 250,000 pallet movements annually. Our competency with respect to lean ensures that we incorporate the necessary processes of checks as we receive, put away, store, pick, pack; and dispatch each and every consignment.
In addition to the standard processes we do offer clients value added services. This project-based work includes requests to inspect, validate, pack and custom unit packing. We engage with operations; production, engineering and our clients QA to agree production line protocol; we take responsibility to select & train from our local talent pool which allows us to offer a flexible solution to increase resources, should demand require.
We have on more than one occasion redesigned the production flow and agreed in advance with key stakeholders, this process is managed through our QA change control protocol. This brings an operational flexibility which complements our client’s requirements.
Construction & Project Management:
Our 13 acre site in Inniskeen was developed and built by our own team of SME’s from within the business. We have 5 buildings on the Inniskeen site that we designed, tendered, contracted and built. We managed the entire process from concept to completion.
When the business expanded we acquired a 21 acre site in Hollystown, Dublin 15. We applied the same principals to this facility. We started with our design and this was then broken down into 10 separate packages (steel, cladding, flooring, equipment, engineering etc..) which went to the market for tendering. We then project managed the complete process of the build from greenfield to completion. This was done in a planned and structured manner and was delivered on time and within budget.
We currently have a QA department which consists of 2 RP’s (Responsible Person), 1 per site Inniskeen and Hollystown, deputy RP’s and a QA Manager. They are responsible for the entire quality portfolio within the business. This includes auditing, accreditations, compliance with all regulatory bodies, temperature mapping and validation. This department currently handles over 30 audits per year from regulatory & competent authorities, clients and our clients end clients. We hold a WDA (Wholesale Distribution Authorisation) issued by the Health Products Regulatory Authority; we have also been successfully audited at our Inniskeen facility on 3 separate occasions over the last 6 years by the FDA.
We have also been audited, without any observations or findings by the CNCA (Certificate and Accreditation Administration of the People’s Republic of China). We are registered as a Known Consignor Pick & Pack and have a registered security programme with the IAA (Irish Aviation Authority). We have secured AEO status which is a certified standard issued by Customs and Revenue for both Security and Customs Simplification processes. All quality related SOPs’ and Manuals are incorporated within our ISO 9001:2015 certification. Recently we combined our Project Management skill set in order to ensure that our temperature controlled solution was not only delivered on time, but it was temperature mapped, validated and audited by the HPRA in line with an extremely tight timeline. Throughout the build process we engaged extensively with the HPRA; we communicated our timelines which we used to schedule and coordinate our HPRA audit. This proactive engagement proved to be very successful in optimising the time required to process licence amendments for both ourselves and our end clients.
Our Hollystown site is located just off the M50 nestled between the N2 and N3. This strategic location is minutes from Dublin Airport and Dublin Port. The newly proposed Dublin Inland Port which will be located at Coldwinters is less than 4kms away. The combination of our location and AEO status does bring a significant benefit as Brexit gets closer.