STEFAN PANTELIC
Summary
Strategic GMP Compliance Manager / Supervisor with 8+ years of progressive experience in EU-regulated pharmaceutical manufacturing. Proven leadership of cross-functional teams, streamline production processes and GMP compliance. Skilled in deviation management, CAPA, and continuous improvement initiatives. Currently serving as Deputy Head of Production under §12 AMWHV and certified internal trainer for QMS processes. Known for a hands-on, solution-oriented approach and strong communication skills in both English and German (C2 & C1).
Overview
11
11
years of professional experience
1
1
Certification
Work History
Supervisor GMP Compliance
Catalent Pharma Solutions
06.2022 - Current
- Lead and professionally manage a team of 10 GMP professionals, with functional responsibility for an additional 12 experts
- Oversaw continuous process improvement initiatives, including label print and shop floor workflows, resulting in cumulative savings of over 160 working hours per month.
- Led a cross-functional project to redesign sample handling process, coordinating with QA and warehouse teams to improve storage layout and reduce processing time by 12 hours/month.
- Act as Deputy Head of Production (§12 AMWHV), ensuring compliance with regulatory expectations and supporting daily operations at the production level.
- Created and/or revised over 50 GMP documents, including SOPs, Work Instructions, and Handling Instructions, using EDMS-based documentation control systems.
- Led and authored over 100 deviation investigations, with an average closure time of 15 days, applying structured root cause analysis tools including Ishikawa, 5 Whys, risk assessments, and cross-functional brainstorming to ensure effective CAPA definition and sustainable compliance.
- Supported internal audits, client inspections, and EHS walkthrough while tracking operational KPIs and driving a culture of continuous improvement.
- Certified internal trainer for GMP and QMS-related processes, supporting the development of new employees and specialists.
GMP Expert Production
Catalent Pharma Solutions
10.2021 - 06.2022
- Proved successful working within tight deadlines and fast-paced environment
Quality Assurance Officer
Catalent Pharma Solutions
10.2019 - 10.2021
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
- Conducted evaluations to identify weak areas and identify problematic issues while promoting corrective methods
- Main QA contact person for the operations department as support in daily processes
Machine Operator
Catalent Pharma Solutions
02.2018 - 09.2019
- Operated packaging lines (blister, bottle, stickpacks) ensuring GMP-compliant output.
Production Assistant
Catalent Pharma Solutions
06.2017 - 02.2018
Communication Coordinator
RGB Group
10.2014 - 06.2017
- Supported external communications and team organization in a marketing-focused environment.
Education
Bachelor of science - Biology
Belgrade University
09.2014
Skills
- GMP Compliance & Regulatory Standards (EU GMP, GDP, ICH, AMG, AMWHV)
- Quality Management Systems (QMS) – Deviations, CAPA, Change Control, Complaints
- Lean Manufacturing & Six Sigma (Green Belt in progress)
- Operational Excellence & Continuous Improvement
- Deviation Investigation & Root Cause Analysis (Ishikawa, 5 Whys, Risk Assessments)
- Regulatory Audit Inspection Support (Tübingen Regional Government Authority, FDA, Customer Visits)
- SOP Development & Revision
- Risk Assessment & Mitigation
- Cross-functional Leadership & Training
- KPI Tracking & Process Optimization
- Organization and Time Management
- Decision-Making
- Communication skills
- Customer service
Certification
- Blue Belt for Customer Dedication Services (2022)
- LEAD NOW Certification Leadership Development Program (2024)
- Certified QMS Trainer (Deviations, Change Control, Complaints, CAPA etc.) Internal (2020)
- Green Belt Six Sigma (in progress - expected 2026)
LANGUAGES
Serbian: Mother language
German: Advanced (C1)
English: Excellent (C2)
Spanish: Beginner
Citizenship: German (EU)
Available to relocate to Switzerland
Timeline
Supervisor GMP Compliance
Catalent Pharma Solutions
06.2022 - Current
GMP Expert Production
Catalent Pharma Solutions
10.2021 - 06.2022
Quality Assurance Officer
Catalent Pharma Solutions
10.2019 - 10.2021
Machine Operator
Catalent Pharma Solutions
02.2018 - 09.2019
Production Assistant
Catalent Pharma Solutions
06.2017 - 02.2018
Communication Coordinator
RGB Group
10.2014 - 06.2017
Bachelor of science - Biology
Belgrade University
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