Experience

DB Alliance Ltd

• Ireland
• IT Services and IT Consulting
• 1 - 100 Employee

• Business & eQMS Analyst

  • Jan 2012 - Present

• TrackWise eQMS Consultant

  • Jan 2012 - Present

• TrackWise Consultant / Administrator

  • Jan 2012 - Present

  As a member of the TrackWise Team within DB Alliance, as a TrackWise Consultant / Administrator, I am and have worked in supporting the following pharmaceutical companies :- - Alexion Pharmaceuticals plc from April 2016 - Present - Amryt Pharma from January 2020 - Present - Norbrook Laboratories Limited from January 2018 - June 2018 - Sandoz from February 2012 - December 2015 I have TrackWise expertise in configuration along with • Troubleshooting and resolving L2… Show more As a member of the TrackWise Team within DB Alliance, as a TrackWise Consultant / Administrator, I am and have worked in supporting the following pharmaceutical companies :- - Alexion Pharmaceuticals plc from April 2016 - Present - Amryt Pharma from January 2020 - Present - Norbrook Laboratories Limited from January 2018 - June 2018 - Sandoz from February 2012 - December 2015 I have TrackWise expertise in configuration along with • Troubleshooting and resolving L2 support issues such as record and configuration issues • Performing PR Import, Master data Import, creation of User access and selection value updates on a daily basis • Performing Detail Data analysis, Data validation and identifying Data quality issues • Conducting regular ticket review analysis, suggest and implement continuous improvement



Amryt Pharma

• Biotechnology Research
• 100 - 200 Employee

• EXT TrackWise Consultant

  • Jan 2020 - Present

  Amryt Pharma - January 2020 - Present I am a member of the TrackWise Development Team for the Amryt TrackWise system and supporting their global user population. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following: - Development from work shop creation to production go live - this includes process creation, process updates and continuous improvement. - Providing system support, user support… Show more Amryt Pharma - January 2020 - Present I am a member of the TrackWise Development Team for the Amryt TrackWise system and supporting their global user population. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following: - Development from work shop creation to production go live - this includes process creation, process updates and continuous improvement. - Providing system support, user support and TrackWise analyst support / recommendations - Responding to user created incidents and enquires within defined service level agreements (second level). - Documentation (SOPs, Work Instructions etc) support. Including but not limited to the preparation of documentation. - Execution of OQ test plans as part of release validation activities. Show less Amryt Pharma - January 2020 - Present I am a member of the TrackWise Development Team for the Amryt TrackWise system and supporting their global user population. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following: - Development from work shop creation to production go live - this includes process creation, process updates and continuous improvement. - Providing system support, user support… Show more Amryt Pharma - January 2020 - Present I am a member of the TrackWise Development Team for the Amryt TrackWise system and supporting their global user population. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following: - Development from work shop creation to production go live - this includes process creation, process updates and continuous improvement. - Providing system support, user support and TrackWise analyst support / recommendations - Responding to user created incidents and enquires within defined service level agreements (second level). - Documentation (SOPs, Work Instructions etc) support. Including but not limited to the preparation of documentation. - Execution of OQ test plans as part of release validation activities. Show less



Alexion Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• EXT TrackWise Consultant

  • Apr 2016 - Present

  Alexion Pharma : TrackWise Administrator from April 2016 - present I am a member of the TrackWise Development Team for the Alexion TrackWise system and supporting their global user population of 850+ users. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following : - Development from work shop creation to production go live : this includes process creation, process updates and continuous… Show more Alexion Pharma : TrackWise Administrator from April 2016 - present I am a member of the TrackWise Development Team for the Alexion TrackWise system and supporting their global user population of 850+ users. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following : - Development from work shop creation to production go live : this includes process creation, process updates and continuous improvement. - Providing system support, user support and TrackWise analyst support / recommendations. - Responding to user created incidents and enquires within defined service level agreements using the Service Now tool (second level). - Raising support tickets with third parties (Sparta Systems), liaising with external support groups and managing issues to resolution. - Point of contact for the TrackWise support representatives in the management of user accounts: Creation, modification and deactivation of accounts and Master Data (Selection Values) according to the defined processes. - Maintaining documentation (SOPs, Work Instructions etc). Preparation of documentation according to release Validation Plan. - Execution of OQ test plans as part of release validation activities. Show less Alexion Pharma : TrackWise Administrator from April 2016 - present I am a member of the TrackWise Development Team for the Alexion TrackWise system and supporting their global user population of 850+ users. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following : - Development from work shop creation to production go live : this includes process creation, process updates and continuous… Show more Alexion Pharma : TrackWise Administrator from April 2016 - present I am a member of the TrackWise Development Team for the Alexion TrackWise system and supporting their global user population of 850+ users. As member of a Global Team supporting an EQMS system, TrackWise, for a major Pharmaceutical company my duties include the following : - Development from work shop creation to production go live : this includes process creation, process updates and continuous improvement. - Providing system support, user support and TrackWise analyst support / recommendations. - Responding to user created incidents and enquires within defined service level agreements using the Service Now tool (second level). - Raising support tickets with third parties (Sparta Systems), liaising with external support groups and managing issues to resolution. - Point of contact for the TrackWise support representatives in the management of user accounts: Creation, modification and deactivation of accounts and Master Data (Selection Values) according to the defined processes. - Maintaining documentation (SOPs, Work Instructions etc). Preparation of documentation according to release Validation Plan. - Execution of OQ test plans as part of release validation activities. Show less