Quality, Compliance & Security Consulting

Pharma IT has an experienced team of consultants ready to assist you with services with all areas of Quality and Compliance within the Pharmaceutical, Biotech and Medical Devices industry.

  • Quality Management System(s)
  • Supplier Audits / Vendor Assurance
  • GMP Compliance (Mock) Audits
  • Data Integrity
  • Qualification/ Validation Services
  • Compliance Strategy Development
  • 21 CFR Part 11 / Annex 11 compliance / IT and Computer System Validation
  • Standard Operating Procedures

Pharma IT also have consultants that specializes with Security and EU GDPR.

If you need support don’t hesitate to contact us.

Meet the Quality, Compliance & Security team:

Senior Pharma Consultant
Bettina Kok

Bettina Kok holds more than 15 years’ experience in the medical device industry working with a broad selection of projects in QMS, IT QMS, QA, Pharma IT projects and GDPR. Bettina holds in total 17 years’ experience working under various standards and directives with compliance and documentation, in highly regulated industries. Experience as a Compliance Manager, RA Consultant, Compliance Architect, Vigilance and Complaint Specialist and Track Lead (URS) on IT projects. Hands-on experience with IT and QMS documentation, process mapping, design and implementation of quality processes, to improve and secure compliance requirements.

Bettina has several years of experience with QMS systems preferred in medical device/pharma, ISO 13485 and ISO9001 compliant businesses. Such systems are for example: HIQMS, DOORS, ENOVIA, Track-Wise, Sharepoint, Improve, Veeva and Lotus Notes.

Risk Management, Document Management, Quality Management, Auditor, MDD 93/42 Compliance, EU GDPR, Data Protection Impact Assessment (ISO/IEC29134), Information Privacy Manager (IAPP)
Senior Pharma Consultant
Ole Søndergaard

Senior Compliance and Validation Consultant with +20 years of professional IT experience, quality assurance and test experience, hereof +10 year of experience with compliance, qualification and validation issues within the pharmaceutical industry. Ole has deep insight and hands on experience in all activities in the validation lifecycle – validation planning/strategy, risk assessments, requirements specification, design specification and review, build processes incl. code review and unit/integration testing, qualification testing, validation reporting and maintenance processes incl. change & configuration management and periodic reporting

SAP - GMP Compliance and Validation, SCRUM Foundation, ITQC Consultant Certificate, Computer System Validation Master Class
Pharma Consultant
Emil Rosenthal Jensen

Pharma Consultant Emil Rosenthal Jensen holds experience from several years in the pharmaceutical industry, working with various compliance tasks and implementations within GxP. Emil has hands-on experience with many types of compliance tasks from user requirement specifications and validation plans, testing and reporting to deviation reporting and change control.

Junior Pharma Consultant
Ahmed Al-Ruba

Ahmed Al-Rubai is a junior compliance consultant with a background as cand.pharm. He has experience with GLP, GMP, documentation, laboratory work, project planning and coordination. He has also acquired experience in quality assessment of laboratory products. Furthermore, Ahmed has a strong passion and understanding of IT.

Senior Pharma Consultant
Maria Høyer Engelhardt

Senior Pharma Consultant Maria Høyer Engelhardt holds more than 10 years of experience working in the pharmaceutical industry, working with quality, validation and processes, primarily within Quality Control. She has extensive experience within Quality Control, in particular with documentation, verification and validation of methods, set up and documentation of new processes, SOP writing and LEAN. Furthermore, she has good knowledge of QMS systems and the document structure.

Experience with development and validation of microbiological methods and  methods for raw materials.

Various cGMP courses , LEAN, Project Management
Junior Pharma Consultant
Sara Krarup Nielsen

Junior compliance consultant Sara Krarup Nielsen is Cand.Pharm. and has experience with various tasks of protocol development, implementation, optimization and validation. She has experience with scientific writing of articles for publication and with co-supervision, training and laboratory work. Sara has also worked with data analysis.

Senior Pharma Consultant
Maiken Forsberg

Pharmacist with 10 years of compliance and  IT System Management experience in line with GAMP 5, 21 CFR Part 11, ISO/IEC 27000 suite for IT security, ITIL and ICH guidelines (GMP, GLP, GCP, GVP). Maiken has helped several pharma companies establishing or improving IT documentation and SOPs prior audits or inspections with good results. She has implemented as well as retired a variety of complex pharmaceutical IT systems. 

ITIL 4 Foundation Certification, LEAN (cLEAN), eTIMS, GAMP 5 - 21 CFR Part 11 Data Integrity and IT Security, GAMP 5 ISPE, TIMS training
Senior Pharma Consultant
Pia Nøhr Ellegaard

Pia Nøhr Ellegaard holds more than 20 years of experience with Software-, Hardware and implementation projects of which 11 years have been in the pharmaceutical industry.
She is highly specialized in GxP. She has performed in roles such as Compliance Consultant , Test Manager, Trainer and QA. She has worked within most pharma domains.

ECA Certified Computer Validation Manager, ISEB Certified Tester
Junior Pharma Consultant
Tea Mansa Larsen

Tea Mansa Larsen is Cand. pharm with 3 years’ experience in quality and compliance support within Regulatory affairs. Tea has experience with various task of creating, extracting and archiving documentation. She has been assisting in reviewing and handling submission documents and supporting the Regulatory department in various quality tasks. Tea also has teaching experience in Quality Control and Laboratory work.

Quality & Compliance Consultant
Mike Astrup Nygaard

Experience from several pharmaceutical companies, working with various compliance and test assignments within GxP. Mike is experienced in taking lead and ownership of all types of compliance tasks from user requirement specifications, to validation plans, testing and reporting.

Mike has performed the role as Compliance Consultant, Validation Lead and Test Manager on IT projects and is specialized in GxP.

Mike has hands-on experience with preparing, reviewing and ensuring the right level of compliance in documentation for GxP systems – from Validation and Quality plans, URS, Risk Assessments, protocols and test cases to reports.

He has experience from international projects and teams with different nationalities. Mike is accustomed to working with several stakeholders and communicating at all levels of the organization.

ITIL, ISPE GAMP5
Quality & Compliance Consultant
Marianne Munck

More than 25 years’ experience in the Pharmaceutical Industry with a strong understanding of the pharma business by working in companies like Novo Nordisk, Bristol-Myers Squibb and NNIT in various areas: Quality Control, Quality Assurance, Organic Synthesis, Basic Research, Pharmacovigilance and life science IT Systems.

Computerized System Validation, Maintaining Control in Operation, Computer System Validation Master Class
Quality & Compliance Consultant
Tine Falk

More than 15 years of experience with implementation projects and system operation. She is highly specialized in GxP. She has performed in roles such as Compliance Consultant and Test Manager.

Tine also have 5 years of experience as SAP System Manager in a highly complex environment.

Computerized System Validation, ISEB Foundation and ITIL Foundation
Quality & Compliance Consultant
Nini Redøhl

More than 10 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certification: ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe 4 Agilist
Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Quality & Compliance Consultant
Lea Elsborg Olsen

Holds experience working with data, modelling and statistical analyses within the cancer research industry. Assisting Compliance Manager experience. She holds a Cand.Scient. in Health Informatics.

Foundation ISTQB Certified Tester programme, Computerized System Validation/GAMP5
Quality & Compliance Consultant
Jesper Damborg Bendtsen

Holds more than 17 years’ experience in the pharmaceutical industry working with validation and compliance. Jesper’s experience spans IT implementation projects, validation, compliance projects, and IT system administration.

SAFe 5 Agilist, Avoiding non-Compliance in Packaging Operations; Validation of Ventilation (HVAC); QA and System Manager for GxP critical IT systems; Qualification of cooling facilities
Quality & Compliance Consultant
Ilhem Sahnoun Østergaard

Senior Consultant with over eighteen years’ experience in the Pharmaceuticals Industry.
Active senior level professional with extensive experience in Computer System Validation (CSV) and in Test Management.
Background includes: Management of IT Compliance, IT Project Management in GXP area, Computer System Validation, IT Quality Assurance, Qualification of the GXP IT infrastructure, advising/consulting with IT associates on matters pertaining to compliance, conducting Training in GXP, Management and Administration of GXP applications.

Certified in Computerized System Validation/GAMP5
HeidiNoerTroelsenR
Quality & Compliance Consultant
Heidi Noer Troelsen

QA and Compliance Specialist with +20 years of experiences within the Pharmaceutical industry. Hands on experienced as a laboratory Technician, IT supporter, Project Manager, IT QA, Quality Specialist, QA, IT Compliance Consultant, Auditor, QA People Manager and Quality Director.

Certified in GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, Quality Risk Management, Audit Management and ITIL
FieKrossdal
Quality & Compliance Consultant
Fie Krossdal

Cand. Scient. in Health Informatics.

2 years of experience within IT compliance assisting Validation Track Lead in IT implementation projects.

Experience with RPA(programming and processes) projects as well.

Certified in Computerized System Validation/GAMP5
Business Consultant
Steen Lindebjerg

IT Program/Project Manager and Senior Pharma Consultant within Identity Management and GDPR with more than 20 years of experience from the IT industry within Pharmaceutical, Finance, Food and Public sectors. Experience with wide range of projects and operation in Infrastructure, IAM & Security, Application development, process optimization and IT service management.

SAFe 4 Agilist, PRINCE2, ITIL, GDPR Practitioner, CIPP/E and Certified Engineer in Microsoft Infrastructure MSCE and Nowell Network CNE
DorteJuulR
Quality & Compliance Consultant
Dorte Juul

More than 13 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation- and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certification: CISA, ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe Agilist
DanAndersenR
Quality & Compliance Consultant
Dan Andersen

30 years of pharma experience from multiple area of business and levels of responsibility with a constant focus of delivering compliant solutions. Hands on experienced as a Security Manager, QA, Compliance Specialist, Validation Specialist, Project Manager and Process Technician.

Certified in CISSP (IT security), CISA (IS Audit), CISM (Security Manager), GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, LEAN and ITIL, Veeva
Senior Pharma Consultant
Peter Noes

Information technology professional with more than 15 years of experience from the pharmaceutical industry. Extensive business understanding and experience from IT projects mainly within the areas of Regulatory Operations – eSubmission/eCTD, Regulatory Information Management Systems (RIMS), Electronic Documents Management Systems (EDMS), XEVMPD and IDMP. Broad experience with project management, system administration and system implementation and with establishing and optimizing business processes within GxP areas.

Veeva White Belt Certification, Computerized System Validation/GAMP5 and GDPR Foundation
BenedikteMarieDueBW
Quality & Compliance Consultant
Benedikte Marie Due

More than 10 years of experience with IT compliance. Working as Validation Track Lead in IT implementation projects and as Business Consultant in system operation and maintenance.

Experience primarily with corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certified in Computerized System Validation/GAMP5, Certified Veeva Vault Administrator, Veeva
Business Consultant, Quality & Compliance Consultant
Lene Hyldgaard Jensen

Experienced Business Consultant with more than  10 years’ experience in the pharmaceutical industry working in various business partnering roles, preparing business analysis, facilitating workshops, transforming business requirements into IT development and implementation projects and delivering subject matter expert assignments, especially in the Regulatory area. Hands on Quality and Compliance experience with GxP IT systems and writing of Standard Operating Procedures.

ISPE GAMP 5, ITIL, Project Management, GLP, GCP, Veeva
Quality & Compliance Consultant
Anders Winkel

Anders Winkel has 9 years of work experience doing research at the University of Copenhagen. He has had experience in using a broad suite of analytical software such as Graph Pad Prism, SensorTrace Suite, PicoLog and GIS.

In Pharma IT he is acting as assisting compliance manager and he has also led several process analysis initiatives.

GAMP 5
JRK 2017 BW
Business Consultant
Jannie Rosenkjær Melbye

Senior Pharma Consultant with 11 years’ experience within document/information and application management. 17 years’ of experience in the field between IT and business. Experience with GxP, application management – especially document management, functional and technical support, test and validation. Furthermore, experience within ITIL, vendor management, communication with end users, transition and application management.

Certified in ITIL, Computerized System Validation, SAFe Agilist
Quality & Compliance Consultant
Anders Jakobsson

Anders Jakobsson holds in total 36 years of experience in Software quality and development. Anders holds more than 25 years of experience in the pharmaceutical industry working with QA, regulatory compliance, supplier audits and QMS development and roll-out.

Anders has experience in different areas of the pharmaceutical business such as GCP, GVP, GMP, GDP and medical device. Computer systems support in areas such as Production automation, Laboratory automation, ERP incl. serialization, Pharmacovigilance, Clinical Trials, Regulatory Affairs.

SAFe 4 Agilist, ISA S88 and S95, ISO 9000, 21 CFR Part 11, GMP Training Courses: manufacturing, distribution, auditing, batch release