IT Quality Assurance
IT Quality Assurance | IT Compliance | IT Audits
aroundIT provides professional advice in understanding regulatory requirements to IT, e.g. US 21 CFR Part 11 and EU Annex 11.
I can assist throughout the lifecycle of GxP IT, ranging from initiation, through project and operation to retirement, ie. from quality planning, audits, requirements, test & verification to release.
Experience
Experiences include roles as QA IT, Compliance manager, Compliance Track lead, Lead auditor, Responsible for authority inspections (DKMA, FDA & MHRA). QA on GxP IT system implementations and for IT system operation departments, including Change Control and Deviation handling, advisory, planning, execution and reporting on development and implementation of validation and test strategies
Case 1
Serilization project for Danish pharmaceutical company
Job role: Consultant - Test & Compliance Manager - Tracklead | Feb 2018 – Mar 2019
Project description:
Integration SAP ATTP with 10+ CMOs, EU HUB (EMVS) and cloud broker.
Validation strategy, plan & reporting and related V-model activities for Serilization level 3, 4 & 5 systems (production line sw, SAP ATTP & PO and CMO & cloud broker integration). Includes GAMP category 3, 4 & 5 software. Includes handling IT outsourcing partners compliance activities.
Tracklead reponsible for compliance activities and deliverables, and a team of ressources that includes compliance & test managers, configuration manager and document manager.
Case 2
Audit of US based EDMS supplier for Danish biotech company
Job role: Lead auditor | Aug 2017 – Dec 2017
Project description:
Lead auditor for audit of Global EDMS supplier (US based) for client.
Audit was conducted onsite and based on ISO9001:2015 and GAMP5, including planning, execution and reporting of findings
Case 3
Interim QA for qualification of API / Equipment for Icelandic biopharmaceutical company
Job role: Interim QA | Jun 2016 – Dec 2016
Project description:
Client was building a new Biosimilars API and filling facility on Iceland. Role was to act as internal QA, onsite for client, for API equipment for up- and downstream processes.
This included review and approval of vendor and internal qualification deliverables like VPP, URS, SAT's, IQ's, OQ's and System Impact assessments. In addition, facilitatation and development of Traceability matrices and Critical component assessments, and assisting with review of internal QMS procedures.
