Mike Gannon's Location
Inverness, Scotland, United Kingdom, United Kingdom
Mike Gannon's Contact Details
Mike Gannon work email
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Mike Gannon personal email
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About Mike Gannon
Chartered and Eur Ing Chemical Engineer, with experience across the Medical Device, Biotechnology, Pharmaceutical and Speciality Chemical Industries. Successful track record of working in many areas such as Operations, Development, Quality, Facilities and EngineeringSpecialties: Process Validation, Problem Solving, Commissioning, Talent Development, Quality Systems, Corrective Action Preventative Action, Process Improvement, Process Development
Mike Gannon Work Experience Details
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Director, Product QualityLifescan Oct 2018 - PresentMalvern, Pa, UsResponsible for design quality throughout the product lifecycle both in new product introduction as well as sustaining design activities for both Digital Solutions and BGM. also responsible for quality within the Distribution Chain and Market Quality -
Senior Manager, Franchise Quality EngineeringLifescan Jun 2015 - Sep 2018Malvern, Pa, UsManages Quality Lifecycle Engineering (QLE) in addressing and dealing with all JJDS Product Lifecycle activities and challenges, Establish, define Customer Experience Engineering (CxE) for JJDS
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Product Lifecycle ManagerLifescan Nov 2011 - Jun 2015Malvern, Pa, UsProduct Lifecycle ManagementPrimary interface between Franchise QRC and Sector level Quality Operations organization. Develop quality strategies for new product introduction and lifecycle management aligned with Franchise strategy. Assures execution and delivery through cross-functional partnership with Franchise R&D and Operations development and with Sector supply chain and Sector Quality Operations. Assures appropriate collaboration with Sector Quality Operations during tech transfer and post launch. Monitor quality metrics across the Franchise to identify systemic product and process issues assuring appropriate investigation, correction, corrective and preventative action when needed. Accountable for the LifeCycle Management quality system for all Franchise sites. Packaging and LabellingLead Quality Packaging and Labelling SupportAllocate Quality Resource to support P &L functionsDrive Quality into P&L ProcessesSupport attainment of P&L Strategies and GoalsDistribution Centre SupportLead Quality support to the Distribution Centres and affiliates Allocate Quality Resource to support Distribution Centres’Drive Quality into Distribution Centre Processes Support attainment of Distribution Centres’ Strategies and GoalsStatistical Support Support the Statistician’s in the fulfillment of their roleMediate on resource issues and provide direction when required
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Staff EngineerLifescan Apr 2005 - Dec 2011Malvern, Pa, Us·Presentation of documentation during regulatory inspections·Interfacing with different teams to work towards a common understanding and implementation of the Quality Systems and promote improvements within systems·Interfacing with Development, Operations, Engineering and Product Support to ensure a common interpretation of procedures and implementation of procedures·Development of staff on projects and teams to ensure that projects are carried swiftly and effectively·Facilitate, encourage and coordinate continuous improvement with respect to the LifeScan Quality Systems·Lead to completion any assigned CAPA’s and provide leadership in terms of resolution and communication of Process and Product Quality issues.·Provide leadership in arbitration of issues surrounding implementation of Quality·Maintain an enhanced understanding of all significant Quality Systems (e.g. CAPA, NCMR, Validation, Design Control, Change Control, etc)·Recruitment and Mentoring of Graduates
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Validation Team LeaderLifescan Dec 2003 - Mar 2006Malvern, Pa, Us·Devise and write Lifescan Scotland validation policies and procedures·Presentation of validation documentation during regulatory inspections·Interface with CSV personnel to work towards a common validation process·Interface with Development Assurance, Operations, Engineering and Product Support to ensure a common interpretation of procedures and implementation of procedures·Conduct Validation training to Lifescan Scotland personnel and supplier personnel·Review and approve Validation Plans, Protocols, Reports, Summary Reports and other documentation associated with validations·Develop staff on projects and validation teams to ensure that validation projects are carried out in accordance with Lifescan Scotland Policies and Procedures·To facilitate, encourage and coordinate continuous improvement with respect to validation activities·Review an approval of Change Requests·Performance of Risk Analysis
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Process EngineerInverness Medical Oct 1999 - Jan 2003North Chicago, Illinois, Us· Devise and implementing process improvements· Investigating and dispositioning non-conforming material· Commissioning new or improved processes· Production and execution of validation protocols· Production of Validation reports· Generation of User Requirement Specifications· Equipment Vendor selection· Factory Acceptance Testing· Training of operators· Generation and Maintenance of Validation Procedures· Generation and Maintenance of Specification Procedures· Performance of Validation Training· Presenting to Regulatory bodies· Co-ordination of all validation activities· Review and approval of all Validation activities· Validation status tracking -
Process EngineerChirex(Annan) Feb 1999 - Oct 1999Role (HME/CME Project) Responsibilities included: -·Compilation of risk assessments·Commissioning activities, including PID and PFD review and verification, control loop testing, pressure testing, solvent introduction·Generation and review of plant operating procedures·GMP compliance and ensuring validation and batch paperwork was correctly completed·Safety inspections·Operator training·Water testing and process simulations·Managing shift activities and management of team members·Operation of completed plantRole (Waste stream project): -·Design of modifications·Generation Heat and Mass balances for new recovery process·Selection of in process testing methods·Risk Assessment of recovery process·Commissioning activities, including PID and PFD review and verification, control loop testing, pressure testing, solvent introduction·Costing and procurement of parts·Operator training·Operation of completed plant and recovery process
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Process EngineerGlaxowellcome Oct 1998 - Feb 1999Brentford, Middlesex, GbRole: - To re-design and re-verify the Pilot Plant.To co-ordinate the build, commissioning and validation of a full-scale production plant upgrades. To commission and validate a new Pharmaceutical finishing suite.Responsibilities included: -·Design of modifications·Generation of Heat and Mass balances·Water testing and process simulations·Generation and review of plant operating procedures·GMP compliance and ensuring validation and batch paperwork was correctly completed·Safety inspections·Operator training -
Process EngineerCleveland Biotech Sep 1998 - Oct 1998Role: -To commission and operate a pilot plant skid to evaluate the effectiveness of proposed effluent and treatment plant to operate at the British Steel 42” ands 44” pipe mills.Responsibilities included: -·Commissioning of pilot plant skid·Operation of pilot plant skid·Performance of Total Organic Carbon (TOC) and Chemical Oxygen Demand (COD) testing·Optimisation of pilot plant skid·Decommissioning of pilot plant skid
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Process EngineerHamsphire Chemical Jul 1996 - Sep 1997Role: -To support the bulk manufacture of Cyanide derivatives, introduce New Chemical Entities (NCE) through Pilot Plant to full-scale production and ensure safe operation of all plant.Responsibilities included: -·Support of 24-hour, 365-day production·Design and specification of Chemical Process Plant·Commissioning of Chemical Process Plant including, distillation columns, reactor vessels, batch stills, filters, heat exchangers and tanker loading apparatus·Determination of Control strategies·Technical determination of NCE viability for bulk production scale·Performance of Hazard and Operability Studies (HAZOP) and Hazard Analysis (HAZAN)·Accident Investigation·Working knowledge of chemicals used or produced on site and specific storage and handling methodologies for each
Mike Gannon Skills
Validation
Capa
Medical Devices
Design Control
Iso 13485
Manufacturing
Cross Functional Team Leadership
Gmp
Continuous Improvement
R&d
Change Control
Six Sigma
Fda
Quality Management
Quality Assurance
Root Cause Analysis
Dmaic
Process Improvement
Technology Transfer
Iso 14971
Quality Auditing
Engineering
Fmea
Lean Manufacturing
Problem Solving
Team Leadership
Mentoring
Spc
Quality Systems
Process Validation
Commissioning
Process Development
Talent Development
Cleaning Validation
Team Building
Strategic Planning
Iso
Cgmp
Teamwork
Analysis
Change Management
Computer System Validation
Qsr
Planning
Ts16949
Gamp
Product Life Cycle Management
Quality Engineering
Kaizen
Doe
Mike Gannon Education Details
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Teesside UniversityChemical Engineering
Frequently Asked Questions about Mike Gannon
What company does Mike Gannon work for?
Mike Gannon works for Lifescan
What is Mike Gannon's role at the current company?
Mike Gannon's current role is Director, Product Quality at LifeScan.
What is Mike Gannon's email address?
Mike Gannon's email address is mi****@****b.co.uk
What schools did Mike Gannon attend?
Mike Gannon attended Teesside University.
What skills is Mike Gannon known for?
Mike Gannon has skills like Validation, Capa, Medical Devices, Design Control, Iso 13485, Manufacturing, Cross Functional Team Leadership, Gmp, Continuous Improvement, R&d, Change Control, Six Sigma.
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