validAID

Validation Management (CSV)

Maquet CP, Rastatt
Responsibilities:

  • Computer Sysytem Validation for non-production Systems ("Tools") according to GAMP 5
  • creation of validation documentation, incl.
    • Initial Assessment
    • User Requirements Specification (incl. 21 cfr part 11 requirements)
    • Validation Plan
    • Risk Analysis
    • Design Qualification (DQ)
    • Installation Qualification (IQ)
    • Performance Qualification (PQ)
    • Validation Report
    • Manuals / Instructions

 

Project Management Service (PMO)

CSL Behring GmbH
Responsibilities:

  • Project Management Service for the development and introduction of the new Manufacturing Execution Systems (MES) for Base Fractioning "NBF245"
    (interfaces SAP / LIMS / LOGIC / scheduling system)
  • global project coordination
  • global validation coordination

 

Data Integrity Consulting

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
Responsibilities:

  • Business Process Analysis / Data Mapping
  • FMEA for Data Integrity issues relating to BioMES 6 & 7

Quality Management Consulting (QM)

CSL Behring GmbH
Responsibilities:

  • Review of the Quality Management Systems for Engineering/Production in regard of Data Integrity / Raw Data definitions
  • GAP analysis and compilation of a GAP-List
  • Development of Policies and Procedures to close existing gaps in regard to regulatory expectations

 

Quality Management (QM)

CSL Behring GmbH
Responsibilities:

  • Validation of the Quality Management Systems in the area of Engineering with regard to Data Integrity and Raw Data Definitions
  • Compilation of a Fit/Gap-List
  • Development of relevant policies and procedures to close any existing gaps in regard to regulatory requirements and expectations

 

Project Management (PMO)

CSL Behring GmbH
Responsibilities:

  • Project Manager for a new Manufacturing Execution System (MES) in Packaging / Serialization

 

Manufacturing Execution System (MES) Consulting for BioMES 7

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
Responsibilities:

  • Business Process Optimization
  • Design of the Manufacturing Execution System according to the business process
  • Development of generic Master Batch Records (gMBRs)
  • Validation of the Manufacturing Execution System

 

Validation Management (TrackWise)

CSL Behring GmbH
Responsibilities:

  • Development of a system-specific Template for the Periodic Review
  • Conducting Periodic Reviews for the TrackWise System at multiple sites

 

Technical Documentation Management

DePuy Synthes GmbH
Responsibilities:

  • Document Change Control
  • Creation and maintenance of Quality Progress Reports QSM Report
  • Audit preparation

 

Master Production Records

Rentschler Biotechnologie GmbH
Responsibilities:

  • Development and revision of master production records
  • Revision of flowcharts (MS Visio)

 

Computer System Validation

CSL Behring GmbH
Responsibilities:

  • Develop initial risk assessment and validation plan according to GMP Annex 11
  • Revise change and test procedures
  • Summarize results in validation report

 

Business Process Modeling

Merck Serono KGaA
Responsibilities:

  • Drafting questionnaire to document the current process (as-is)
  • Developing a methodology to guide from current process documentation to drafting the to-be process
  • Conducting interviews at multiple sites/divisions to document the current divergent quality business processes globally
  • Consolidating the results and drafting of a best-practice approach for global quality process unification (Pharma)
  • Drafting a map of quality process interactions (Pharma)

 

Validation Management (MES)

CSL Behring GmbH
Responsibilities:

  • Creation of the Quality Plan (Risk Analysis)
  • Revision of the Requirement Specifications
  • Creation and execution of the validation documents (IQ/OQ/PQ)

 

Validation Management (Literature Database)

CSL Behring GmbH
Responsibilities:

  • Validation Responsible and Test Lead
  • Coordination of validation activities
  • Creation of the validation documentation (incl. Val.-Plan / Test-Plan / Risk-Assessments / Testcases / Test-Report / Val.-Report)

 

Validation Management (Equipment / Applications)

DePuy Synthes (Johnson & Johnson)
Responsibilities:

  • Legacy Reviews of production equipment and applications
  • Creation of validation documentation according to the current workframe
  • Overseeing the necessary re-validation activities
  • Preparing improvement propositions to optimize the current workframe

 

Project Lead

CSL Behring GmbH
Responsibilities:

  • Developing a concept for a TrackWise-SAP Interface to automatically transfer Quality Notification information bi-directionally
  • Coordination of all validation- and stakeholder activities (e.g. timely SOP creation) to comply with regulations and project timelines
  • Creation and control of all the validation documentation (incl. Val.-Plan / Test-Plan / Risk-Assessments / Testcases / Test-Report / Val.-Report)
  • Finalizing the validation and Hand-Over to the customer

 

Quality / Regulatory Management

DePuy Synthes (Johnson & Johnson)
Responsibilities:

  • 21CFR820: Quality System Regulation: Legacy Management Reviews,
  • Highlighting quality risks and designing/implementing mitigation activities,
  • Further review and remediation activities within NCR, CAPA DocControl etc.

 

Validation Management (Analytical Methods)

Sanofi Aventis Deutschland GmbH
Responsibilities:

  • Development and validation of HPLC methods for insulins analogs
  • Authoring documents for module 3.2.P.5 of the registration for insulins analogs

 

Supplier Management

Paul Hartmann AG
Responsibilities:

  • Development of a concept for supplier management according to 21 CFR part 820
  • Authoring and proof reading of supplier questionnaires

 

Validation Management (Sub-Project Lead)

CSL Behring GmbH
Responsibilities:

  • Conceptual development of the validation approch according to existing IT Quality Management Systems
  • Coordination of all validation activities and communication to stakeholders to ensure compliance and project milestones / timelines
  • Authoring and control of all validation documentation (incl. Val.-Plan / Test-Plan / Risk-Assessments / Testcases / Test-Report / Val.-Report / ...)
  • Closure of all validation activities and hand-over to customer for productive use

 

CMC-Management

Boehringer Ingelheim Pharma GmbH & Co. KG
Responsibilities:

  • Authoring of registration documentation for APIs, Module 3.2.S.
  • Communication with international drug administrations and customers
  • Working with Changes and CAPAs
  • Regulatory supervision of product transfers

 

Chemical Qualification Management

B. Braun Avitum AG
Responsibilities:

  • Development of primary packaging materials for pharmaceutical products and medical devices
  • Authoring of SOPs, registration documentation and specifications
  • Investigation of extractables and leachables
  • Raw material qualification, stability studies
  • Communication with suppliers and contract laboratories

 

Artwork Coordination

ACTAVIS Deutschland GmbH & Co. KG
Responsibilities:

  • Development and build of a new database structure for current and superceded versions of artwork
  • Definition of a new release process for artwork
  • Review of the Standard Size Labeling (Packaging Size Act) according to the German Act for Restructuring the Drug Market (AMNOG)
  • Modification of all packaging materials to reflect the new address in Munich (after relocation from Langenfeld)
  • Review of packaging material texts for conformity to the registration

 

Regulatory Affairs Labelling Management

ACTAVIS Deutschland GmbH & Co. KG
Responsibilities:

  • Authoring texts for packaging material, product characteristics- and usage information (patient information leaflet)
  • Information Officer according to § 74a AMG
  • Review and release of all packaging material
  • Supervision of all regulatory drug approvals
  • Extension of variations in DCP-, MRP-, central or national approval processes

 

Head of Research and Development and Head of Quality Control

GRILLO Zinkoxid GmbH
Responsibilities:

  • Implementation of GMP to Quality Control and to Production
  • Qualification, validation, stability studies
  • Authoring of SOPs and specifications
  • Hosting customer audits and conducting trainings
  • Technically advising customers and handling product complaints
  • Regulatory Affairs
    • Authoring a Drug Master File (DMF) for zinc oxide
    • Supporting customers registrating drug products containing zinc oxide as an API / communication with the local drug registration offices
    • Registration of zinc oxide as feed additive according to EU/1831/2003
    • Registration of nano zinc oxide as a UV-protective agent in cosmetics

 

Process Management

CSL Behring GmbH
Responsibilities:

  • Planning & comissioning of a new Albumin ultra-filtration plant
  • Process analysis for simulation / planning
  • Development of new processes for extended capacity (output)
  • Authoring / modifying SOPs
  • Development of a concept for mapping new processes to Electronic Batch Records in the Manufacturing Execution System, PAS-X (Werum)
  • User acceptance testing (FAT/SAT) incl. automation
  • Conducting and documenting plant qualification
  • Training staff

 

Qualification Management

CSL Behring GmbH
Responsibilities:

  • Planning, execution and documentation of the validation of the Manufacturing Execution System, PAS-X (Werum)
  • Developing the concepts for Master Batch Records (MBRs)
  • Authoring / modifying SOPs
  • Risk Assessment (FMEA)
  • Training staff

 

Documentation Management

ZLB Behring GmbH
Responsibilities:

  • Development of a concept for Master Data Management and its documentation
  • Authoring of a Master Data Management Handbook
  • Training staff

 

validAID

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Helmut M. Rector
mobile: +49(0)163 246 2978
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