Migle Cousins

• UK WDA(H) client: Successfully managed an 8-week project to transition from a paper-based QMS to an electronic QMS (eQMS). Oversaw the update of Standard Operating Procedures (SOPs) to enhance process efficiency and compliance.
• UK Medical Device client: Directed a 7-month project focused on preparing technical files for in-vitro medical devices, for obtaining ISO 13485 certification. ISO certification was obtained following a successful audit. Provided critical support for GMP audits and successfully obtained GMP certificate issued by Bulgarian Drug Agency.
• UK MAH & WDA(H) client: Named RP, RPi, QMS maintenance support, inspection readiness, risk management implementation

• Built a bespoke, manual QMS system and successful obtaining a WDA(h) for Dutch market (sister company).
• Ensuring compliance with GMP, GDP, MDR, and ISO 9001 standards across UK and Dutch (MAH/WDA responsibilities) operations.
• RP & RPi duties under UK regulations, overseeing the procurement, import, export, supply and holding of pharmaceuticals.
• Evaluating and supporting management of external partners, service providers and vendors who have an impact on GMP, GDP or GVP.
• CMO oversight for GMP compliance
• Managing of complex supply chains in EU and UK
• Direct line management to warehouse staff, focusing on performance, training, and cross-functional collaboration.

• GAP analysis and structured remediation of QMS as a whole
• Building process for qualification of suppliers and customers (nationally, and export)
• Building bespoke training programs for all aspects of GDP
• Management of ISO 9001 compliance across UK operations
• Direct support to the Responsible Person (RP), acted as Deputy RP in RPs absence for 6 months

• Direct support to the Responsible Person (RP)/Qualified Person (QP) in Covid response.
• Maintained QMS, including complaints, deviations, CAPAs, change controls
• Reviewed SOPs and implemented new processed for Covid response.
• Managed self-inspections and mock recalls
• Qualified suppliers and customers for Covid-related public tenders and supply of products.
• Managed GDP-related change control during the company's transition from PHE to UKHSA.
• Oversaw and managed issues at 3PL (NCNs, NCRs, complaints, deviations and overall GDP compliance).
• Conducted local batch release for Covid vaccine to the UK market
• Led monthly QMR meetings with stakeholders.

Overseen customer complaints, supervised investigations, and supported audits. Assisted in deviation investigations and collaborated with stakeholders. Ensured inspection readiness and supported regulatory authority inspections. Contributed to internal audits and self-inspections, managing CAPAs. Conducted local batch release for UK distribution.

• Negotiated contracts with customers for cost-effective solutions that supported project requirements.