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Arjen Kommer is listed as Team Leader at Agidens, a with 486 employees, based in Assendelft, North Holland, Netherlands. AeroLeads shows a matched LinkedIn profile for Arjen Kommer.
Arjen Kommer previously worked as Senior Consultant at Agidens and Data Integrity Specialist | System Administrator at Eurofins Biopharma Product Testing Netherlands. Arjen Kommer holds Mlo from Bakhuis Roozeboom Instituut.
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I have a dream. That one day we live in a world where all data is trustworthy and accurate and patient safety is guaranteed.
Listed skills include Gamp5, Validation, Computer System Validation, Gmp, and 7 others.
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Leiden, Zuid-Holland, Nederland
Lead, manage and coach an Agidens Validation Services Team of 8 to 15 consultants.• Lead by putting people first;• Manage according to Agidens Values: Show respect - Strive for excellence - Be open minded - Take ownership;• Coach to stimulate growth and engagement by harnessing and encouraging the potential, talents and energy.
Leiden, Zuid-Holland, Nederland
Tasks and responsibilities• Within my function as Senior Consultant, I am responsible for CSV and AIQ according to cGXP regulations, GAMP Life Cycle Approach and current Data Integrity Principles.• Within my role as SPOC (Single Point Of Contact) I am responsible for the daily project and team management of projects within the customer.
Leiden
The Data Integrity Specialist is responsible for ensuring that all produced data is safe, original, trustworthy and accurate.The System Administrator is responsible for ensuring that the systems producing data are configured according to current data integrity principles. Skills:| ALCOA+ | Data Governance | GXP | Disaster Recovery | GAMP5 | Risk Analysis | 21 CFR Part 11 | GDocP | Data Integrity | CSV | Compliance | Business Continuity | Audit Trail review |Tasks and responsibilities:• Evaluation and validation of laboratory software applications and computer systems concerning data integrity compliance.• Management and validation of application security configuration and user access.• First point of contact on data governance, integrity and security.• Monitoring of the Quality System and GxP data flows to detect data integrity flaws and conduct problem resolution to ensure data integrity.• Identifying, risk assessing, correcting and minimizing (potential) data integrity risks.• Training of staff and business to raise overall ethics and data integrity awareness.• Data Integrity Subject Matter Expert during regulatory inspections and client audits.• Member of the EBPT Global Data Integrity Council which aims to harmonize the approach to achieving and demonstrating data integrity compliance amongst different laboratories within the group.
Zaanstad En Omgeving, Nederland
Skills:| ALCOA+ | Data Governance | GXP | Disaster Recovery | GAMP5 | Risk Analysis | 21 CFR Part 11 | GDocP | Data Integrity | CSV | Compliance | Business Continuity | Audit Trail review |Tasks and responsibilities:• Evaluation and validation of laboratory software applications and computer systems concerning data integrity compliance.• Management and validation of application security configuration and user access.• Identifying, risk assessing, correcting and minimizing (potential) data integrity risks.• Validation of Excel spreadsheets.• First point of contact for IT related activities.
Zaanstad En Omgeving, Nederland
The team lead was responsible for the day-to-day operation of the departments Products and Stability Studies (from Aug. 2007 to Dec. 2009) and Raw Materials (from Jan. 2011 to Dec 2014). During 2010 I was responsible for the implementation of a LIMS.Tasks and responsibilities:• Supervising, coaching & training of assigned staff.• Executing project coordination activities, such as method and specification review, planning, invoicing and customer support.• Executing quality control activities, such as non-routine analysis, laboratory record review and reporting.• Maintaining cGMP compliance within all areas of responsibility• Responsible for writing technical SOPs to support quality operations.• Executing laboratory investigations, deviations, Risk Assessments, CAPAs and troubleshooting.• Selection and purchase of laboratory equipment and supplies.• Evaluation and validation of laboratory software applications and computer systems concerning data integrity compliance.• Management and validation of application security configuration and user access.• Validation of Excel spreadsheets.
Zaanstad En Omgeving, Nederland
Quality control according to cGMP on pharmaceutical preparations.
Zaandam
Batch Production Quality Control.
Other employees you can reach at agidens.com. View company contacts for 486 employees →
Han Van Gestel
Colleague at AgidensAntwerp Metropolitan Area, Belgium
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RV
Robin Van Cleynenbreugel
Colleague at AgidensTernat, Flemish Region, Belgium
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PW
Patrick Weets
Colleague at AgidensZwijndrecht, Flemish Region, Belgium
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Mokra Elec Mokra Elec
Colleague at AgidensBrussels, Brussels Region, Belgium
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SB
Sebastian Bull
Colleague at AgidensGeel, Flemish Region, Belgium
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ES
Emily Sannen
Colleague at AgidensOud-Turnhout, Flemish Region, Belgium
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SP
Staf Pirijns
Colleague at AgidensAntwerp Metropolitan Area, Belgium
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AB
Angelique Boer
Colleague at AgidensGorinchem, South Holland, Netherlands
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BT
Bart Timmer
Colleague at AgidensAlkmaar, North Holland, Netherlands
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Emmelien De Kempeneer
Colleague at AgidensDiest, Flemish Region, Belgium
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Data Integrity - Requirements for a GMP-compliant Data Life Cycle.
A risk-based validation approach to compliant GxP Computerized Systems.
Quick answers generated from the profile data available on this page.
Arjen Kommer works for Agidens.
Arjen Kommer is listed as Team Leader at Agidens.
Arjen Kommer is based in Assendelft, North Holland, Netherlands while working with Agidens.
Arjen Kommer has worked for Agidens, Eurofins Biopharma Product Testing Netherlands, Farmalyse Bactimm Bv, and Norit Nederland B.V..
Arjen Kommer's colleagues at Agidens include Han Van Gestel, Robin Van Cleynenbreugel, Patrick Weets, Mokra Elec Mokra Elec, and Sebastian Bull.
You can use AeroLeads to view verified contact signals for Arjen Kommer at Agidens, including work email, phone, and LinkedIn data when available.
Arjen Kommer holds Mlo from Bakhuis Roozeboom Instituut.
Arjen Kommer is listed with skills including Gamp5, Validation, Computer System Validation, Gmp, Pharmaceutical Industry, Hplc, Microsoft Excel, and Data Integrity.
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