Freelance GMP & Project Management Consultant – Packaging

Unity Systems; München; Hybrid; EUR 100.000 - 125.000; Teilzeit

Zusammenfassung

A leading consultancy in pharmaceutical projects is seeking a Freelance GMP & Project Management Consultant in Munich. This part-time role focuses on advising packaging operations and ensuring GMP compliance. The ideal candidate has significant industry experience and holds a relevant degree. The position offers up to 1 day of remote work per week, making flexibility a key benefit.

Qualifikationen

• Several years of experience in industrial pharmaceutical manufacturing/packaging.
• Proven expertise in qualification & validation (including PQ).
• Strong knowledge of EU/national/international GMP.

Aufgaben

• Lead and advise on the planning of interdisciplinary packaging projects.
• Support Performance Qualifications (PQ) and validation activities.
• Draft and review GMP documentation.

Kenntnisse

GMP expertise

Project management

Problem-solving

Stakeholder management

Teamwork

Fluent in German

Fluent in English

Ausbildung

Degree in scientific or engineering discipline

Tools

MS Office

SAP

Jobbeschreibung

Overview

Freelance GMP & Project Management Consultant – Packaging (Part-time Contract)

Contract Type: Part-time freelance contract (approx. 20 hours / week)

Duration: 15 September 2025 – 15 March 2026

Location: Pfaffenhofen, Bavaria, Germany (hybrid: up to 1 day / week remote)

Right to Work: Valid EU / German RTW required (no sponsorship available)

The Opportunity

We are seeking an experienced GMP and Project Management Consultant to provide hands-on support for pharmaceutical packaging operations across solid and parenteral dosage forms. This role involves advising cross-functional teams, supporting qualifications and validations (PQ, equipment, processes), strengthening data integrity / CSV compliance, and preparing the site for inspections and audits by health authorities and customers.

Key Responsibilities

• Lead and advise on the planning and delivery of interdisciplinary packaging projects (solid & parenteral).
• Support Performance Qualifications (PQ) and validation activities; establish compliant production and packaging processes.
• Draft and review GMP documentation (SOPs, work instructions, risk assessments) and support deviation / complaint handling.
• Coordinate data integrity and CSV topics (audit-trail review, equipment / system qualification, collaboration with process automation).
• Drive process optimisation while ensuring alignment with GMP, EHS, and business requirements.
• Prepare for and participate in regulatory inspections and third-party / customer audits.
• Act as a consultant for cross-functional project teams, providing guidance on regulatory and technical matters.

Essential Qualifications & Experience

• Degree in a scientific or engineering discipline (e.g., Pharmacy, Chemistry, Biotechnology, Mechanical / Chemical Engineering).
• Several years of experience in industrial pharmaceutical manufacturing / packaging (solid and / or parenteral dosage).
• Proven expertise in qualification & validation (incl. PQ).
• Strong knowledge of EU / national / international GMP.
• Experience drafting / reviewing SOPs, risk assessments, deviation / complaint management.
• Exposure to data integrity / CSV compliance (audit-trail reviews, system / equipment qualification).
• Proficiency in MS Office and SAP.
• Fluent in German and English (spoken and written).
• Strong teamwork, stakeholder management, and precise working style.

Preferred Experience

• Parenteral packaging / sterile fill-finish background.
• Leadership in inspection / audit readiness (EU regulators, FDA, customer audits).
• Experience in process optimisation with consideration for GMP + EHS.
• Functional leadership of cross-functional project teams.