Christopher Doyle Email & Phone Number

United Kingdom

Wrexham, Wrexham, United Kingdom

Serve as technically competent contact for third party technical issues at sterile parenteral product manufacturing sites with regard to product quality and business improvement.Responsible for ensuring the GMP compliance of up to 30 third party manufacturers (including other sites within the corporation). Specifically, sites manufacturing sterile parenteral products.Quality responsibility for critical vendors to the UK manufacturing site, these include API providers and… Show more Serve as technically competent contact for third party technical issues at sterile parenteral product manufacturing sites with regard to product quality and business improvement.Responsible for ensuring the GMP compliance of up to 30 third party manufacturers (including other sites within the corporation). Specifically, sites manufacturing sterile parenteral products.Quality responsibility for critical vendors to the UK manufacturing site, these include API providers and packaging/component suppliers.Provide complete vendor qualification according to corporate quality requirements and GxP.Independently perform or lead audit teams for audits of third party manufacturers, against appropriate cGMP guidelines for Finished Products, APIs, excipients or packaging components (inc. EudraLex and ISO9001.) Practitioner Member of the Chartered Quality Institute (CQI) and International Register of Certificated Auditors (IRCA).Mentor trainee auditors throughout their training and qualification. Actively contribute to the routine operational use of and input to, the site PQS. Prepare KPI information for the Supply Quality group and present to site senior leadership and General Management.Responsibility for monitoring of team KPIs and promoting adherence by leading team meetings. Show less

Liverpool, United Kingdom

Responsibility for the quality relationship between Eli Lilly and numerous varied Contract Manufacturers in the UK and Europe (producing antibiotics, medicated smokes, sprays, gels and powders.)• Make usage decisions for APIs and drug products based on manufacturing and laboratory data from Contract Manufacturers• Assess the impact on Safety, Integrity, Strength, Purity and Quality of deviations and changes at varied manufacturing plants in the UK and Europe. Oversee the… Show more Responsibility for the quality relationship between Eli Lilly and numerous varied Contract Manufacturers in the UK and Europe (producing antibiotics, medicated smokes, sprays, gels and powders.)• Make usage decisions for APIs and drug products based on manufacturing and laboratory data from Contract Manufacturers• Assess the impact on Safety, Integrity, Strength, Purity and Quality of deviations and changes at varied manufacturing plants in the UK and Europe. Oversee the generation, implementation and completion of Corrective and Preventative Actions (CAPAs) arising from these deviations• Manage manufacturing, analytical and packaging changes from proposal to conclusion and effectiveness evaluation• Ownership of specifications for APIs and drug products with responsibility for keeping them in regulatory compliance by responding to changes in registrations.• Represent the QA department in a multidisciplinary joint process team including operations, QA and Technical Support at Contract Manufacturers and local sales, planning and Technical Support• Work with planners and schedulers to meet a demanding production schedule for numerous production sites serving worldwide markets• Ensure compliance with corporate global strategies, local specifications and regulatory commitments• Handling of product complaints in accordance with corporate policy and with customer safety forefront• Take responsibility for initiating, monitoring and approving stability studies critical to regulatory commitments and customer safety • Utilise common industry software such as SAP business software, Salesforce, Trackwise CAPA system and JMP statistics package in order to perform the above responsibilities Show less

Liverpool, United Kingdom

Responsibility for quality for two pharmaceutical manufacturing plants (antibiotic concentrate fluidised spray drying and granulation) and whole of site utilities at a major manufacturing site. • Make usage decisions for APIs based on manufacturing and laboratory data• Assess the impact on Safety, Integrity, Strength, Purity and Quality of deviations and changes• Manage changes from proposal to conclusion and effectiveness evaluation• Ownership of specifications… Show more Responsibility for quality for two pharmaceutical manufacturing plants (antibiotic concentrate fluidised spray drying and granulation) and whole of site utilities at a major manufacturing site. • Make usage decisions for APIs based on manufacturing and laboratory data• Assess the impact on Safety, Integrity, Strength, Purity and Quality of deviations and changes• Manage changes from proposal to conclusion and effectiveness evaluation• Ownership of specifications for APIs and utilities with responsibility for keeping them in regulatory compliance by responding to changes in registrations.• Represent the QA department in a multidisciplinary process flow team including operations, engineering, planning and Technical Support • Work with planners and schedulers to meet a demanding production schedule serving worldwide markets• Ensure compliance with corporate global strategies, local specifications and regulatory commitments• Take responsibility for initiating, monitoring and approving stability studies critical to regulatory commitments and customer safety • Utilise common industry software such as SAP business software, Salesforce, Trackwise CAPA system and JMP statistics package in order to perform the above responsibilities Show less

Speke, Liverpool

Part of the TS/MS (Technical Support/Manufacturing Science) department at a major manufacturing site.• Work with a multidisciplinary team (TS/MS, engineering, production, QC laboratories, quality) to deliver a new facility project according to relevant standards (cGMP, ISO, EN285, HTM2010)• Operation Qualification and Process Qualification for purified water systems, clean steam and cleanrooms• Facilitate the full transfer of operations from one laboratory to another… Show more Part of the TS/MS (Technical Support/Manufacturing Science) department at a major manufacturing site.• Work with a multidisciplinary team (TS/MS, engineering, production, QC laboratories, quality) to deliver a new facility project according to relevant standards (cGMP, ISO, EN285, HTM2010)• Operation Qualification and Process Qualification for purified water systems, clean steam and cleanrooms• Facilitate the full transfer of operations from one laboratory to another through writing a new suite of procedures and technical documents, training, and technical support to the project group• Manage the specification, procurement and installation of new analytical laboratory equipment• Carry out and assist with development work: In the laboratory, assays and culture screens for on-plant trials At the small equipment scale On the production plant (technical support on shift for on-plant trials)• Statistics, Design of Experiment and Statistical Process Control course (JMP) with Global Statistician• Root Cause Investigation 3-day course• SAP Power User Show less

Speke, Liverpool

Culture laboratory work (culture raising, aspetic operations, HPLC, pure culture assessment)Autoclave technical ownershipPre-plant fermentation trials, troubleshooting, problem solving.

Newcastle Upon Tyne, United Kingdom

Army ReservistNorthumbrian Officer Training CorpsTraining in military skills, officership and leadershipTraining coordinated by The Royal Military Academy, SandhurstSkills utilised and assessed on training deployments to regular British Army bases in Germany.