Marcel Pieles - CAPA/Deviation/OOS Manager Solid Dosage Production

Recommended expert

Karlsruhe, Germany

Experience

Apr 2025 - Nov 2025

8 months

Germany

CAPA/Deviation/OOS Manager Solid Dosage Production

Haupt Pharma Wülfing GmbH – Member of the Aenova Group

Independent handling of deviations
Independent handling of CAPAs
Analysis of production OOS – evaluation and closure
Technical consulting in operations
Complete revision of CPV SOP, plan and report
Development of coaching materials for production staff

Aug 2024 - Dec 2024

5 months

Germany

Head of Solid Dosage Manufacturing

Miolma Consulting GmbH

Managing production according to AMWHV and EU GMP guidelines
Creating and training on SOPs, MBRs and other GMP/ISO relevant documentation
Ensuring and reviewing correct batch documentation as well as other quality records (e.g. risk analyses)
Preparation and approval of manufacturing instructions and documents
Implementation of CAPA actions from deviations, customer complaints and audits
Analysis and interpretation of process data and continuous process improvement
Responsible for manpower planning, equipment, customer support and achieving the department’s financial goals
Ensuring successful approval by European authorities and customers
Knowledge bearer for the responsible quality processes
Consulting on validation of manufacturing processes
Representation of the area of responsibility to customers and authorities

Feb 2024 - Jul 2024

6 months

Germany

Head of Sterile Production

Klosterfrau Berlin GmbH

Managing sterile production according to AMWHV and EU GMP guidelines
Advising production to ensure GMP-compliant manufacturing
Evaluation of deviation reports
Preparation and approval of manufacturing instructions and documents
Conducting training and developing GMP guidelines for production
Analysis and interpretation of process data and continuous process improvement
Coordinating assigned employees to ensure the quality of produced products
Ensuring successful approval by European authorities and customers
Knowledge bearer for the responsible quality processes
Consulting on validation of manufacturing processes

Sep 2023 - Jan 2024

5 months

Germany

Head of ODF Manufacturing

Gen-Plus GmbH & Co. KG

Ensuring timely planning, production and monitoring of manufacturing activities according to AMG, AMWHV and EU GMP guidelines
Creating and training on SOPs, MBRs and other GMP/ISO relevant documentation
Ensuring and reviewing correct batch documentation as well as other quality records (e.g. risk analyses)
Initiating, implementing and managing manufacturing-related projects
Collaborating on and handling internal and external complaints and deviations
Implementing CAPA actions from deviations, customer complaints and audits
Approval and oversight of changes in the change control process
Qualification of equipment and facilities as well as process validation
Responsible for manpower planning, equipment, customer support and achieving the department’s financial goals
Representation of the area of responsibility to customers and authorities
Responsible for planning, implementation, monitoring and optimization of work safety, health and environmental protection processes

Apr 2023 - Aug 2023

5 months

Germany

Process Optimization Project Manager Packaging/Product Launch Controlled Substances

Develco Pharma GmbH

Optimizing production workflows in packaging to ensure timely product launch
Revising the planning concept for optimal line utilization
Improving the training system for packaging
Conducting procurement activities
Resource and budget planning
Responsible for all operational planning, execution, control and realization of controlled substances launch projects
Setting objectives and creating project plans
Tracking timelines internally and externally
Conducting project meetings
Reporting to the steering committee

Apr 2021 - Mar 2023

2 years

Germany

Tech Transfer Manager OEB 4/OEB 5 / Project Manager

R-Pharm Germany GmbH

Creating process risk analyses and site-by-site analysis for product transfer in an interdisciplinary project team
Creating transfer protocols and reports including setting up Design of Experiments (DoE)
Supervising tech trials, verification batches, and validation batches
Evaluating and documenting results
Planning and scheduling experiments and ensuring machine availability
Planning and coordinating material requirements and staff allocation
Training staff on transfer activities
Operational planning, execution, control, and realization of OEB 4/5 tech transfer projects
Budget planning
Setting targets and creating project plans
Tracking timelines internally and externally
Conducting project meetings
Reporting to the steering committee

Nov 2020 - Feb 2021

4 months

Germany

Production Coordinator

R-Biopharm AG

Coordinating production and improving processes for SARS-CoV-2 test systems
Boosting efficiency by streamlining production workflows and increasing employee flexibility
Revising manufacturing procedures
Providing technical and disciplinary leadership for 32 production staff
Planning resources and budget
Implementing two semi-automatic filling lines to increase production and optimize material flow

Oct 2019 - Present

6 years 4 months

Head of Production, Project Management, Tech Transfer Management, CAPA Manager and Process Optimization

Freelance Consultant, Interim Manager

Oct 2019 - Sep 2020

1 year

Spain

Interim Head of Production

Hanna Healthcare S.L.

Scaling up a new API for pellets using a bottom spray process from development scale to commercial batch size
Optimizing the spray process to reduce yield losses by setting spray parameters
Creating the validation plan and conducting process validation
Creating manufacturing procedures
Training operators on the new spray process
Planning resources and budget
Providing technical and disciplinary leadership for 14 production staff
Carrying out procurement activities
Developing and implementing a new zoning concept for material and personnel flow due to COVID-19

Oct 2017 - Sep 2019

2 years

Switzerland

Head of Production

Konapharma AG

Boosted production efficiency by 30% by streamlining workflows and increasing employee flexibility
Reduced manufacturing costs by 15% by improving planning and control processes
Optimized product transfers and ensured timely product launches
Cut production deviations by 45% by revising manufacturing procedures and improving the training system
Reduced absenteeism by 30% by increasing employee motivation
Improved workplace safety through regular inspections with cross-department colleagues
Conducted procurement activities
Providing technical and disciplinary leadership for 36 production staff
Preparing and carrying out internal and external audits, reducing findings by 25%
Planning resources and budget

Jan 2009 - Sep 2017

8 years 9 months

Germany

Deputy Head of Production

Hennig Arzneimittel GmbH & Co. KG

Acting as Deputy Head of Production with personnel responsibility for 28 employees
Ensuring compliance with quality, schedule, and cost requirements
Improving workplace safety
Preparing and conducting internal and external audits
Participating in quality circles
Approving and ensuring compliance with manufacturing instructions and SOPs
Training employees
Planning and controlling production processes
Optimizing production workflows
Conducting product transfers

Sep 2007 - Dec 2008

1 year 4 months

Germany

R&D Engineer

Losan Pharma GmbH

Developing stick-pack formulations
Evaluating and co-developing a testing device to check the seal integrity of primary packaging/stick packs in collaboration with Nolek SE
Conducting, analyzing, and documenting tests to develop innovative solid dosage forms
Conducting scale-up experiments
Performing equipment qualification
Administrative tasks