Christopher Azarko Email & Phone Number

Management, distribution and Quality oversight for sterile and non-sterile surgical products, processed within ISO Classification 6 cleanrooms.Developing and maintaining product and cleanroom facility compliance to applicable standards and regulations.Establishing testing protocols and schedules for device bioburden control, endotoxin testing, sterilisation validation (VDmax) and microbiological monitoring (air and surface) of cleanrooms using TSA and SDA settle & contact plates.Technical Construction File (TCF) reviews for multiple product and processing categories, approval and submission of files for audit response.Notified and Certification Body assessment procedure; preparation of technical documentation and process reviews.Quarterly Business Reviews and supplier visits. Forecast of processing volumes, business contingency planning for increased growth and demand. Processing contract renewals.Review and approval of Gamma and X-Ray sterilisation modality protocols, concerning product performance qualification at sterilisation facilities. Development of monitoring processes for effective commissioning and validation of new cleanroom facilities.Maintaining process and product compliance with scheduled internal audits.Standard Procedure Instructions (SPI) composition, up-issuing, training and implementation.Ownership of actions to assess and remedy production issues and address operational risks through Non-Conformance Reports (NCR) and Concessions.Managing diverse resource and production Cell Leaders through regular internal production meetings. Assessing staff capacity against forecasted business growth. Development and training of staff, Health & Safety monitoring, recruitment and retention, critical appraisals and disciplinary procedures.Controlling costs regarding use of consumables, supplier sterilisation activity and ancillary equipment used for packaging and product distribution.

Aston Clinton

Elstree

Managing production and quality of highly innovative implantable devices within an ISO Class 7 cleanroom environment, achieving conformity to specifications as expressed in ISO 13485 and The Food and Drug Agency (FDA) requirements.Conducting environmental monitoring of cleanroom facilities and product bioburden control.Procurement of capital goods as part of continuous improvement.Logistics and transport coordination of direct and return shipments to domestic and international customers.Capacity planning and associated cost analysis against OTIF requirements.

London, United Kingdom

Managing a team of warehouse operatives and delegating tasks accordingly to ensure effective process of supply chain operation.Production planning and agreed despatch schedules with international customers.

London, United Kingdom

Voluntary policing role with full powers of arrest, supporting the work of full time regular police officers in enforcing the law and providing protection to people and property. Developing skills focused on dispute resolution, maintenance of community relations, investigating crimes and providing visible reassurance to members of the public.

London, United Kingdom

Developing and implementing a more cost effective and beneficial faulty stock returns process, resulting in significant refunds from leading foot retail suppliers, supporting company growth and financial viability.