Freelance QA Manager for IT-Department (m/w/d)
Dieses Jobangebot ist nicht länger verfügbar.
Berlin Area (Germany) |
Freelance
Project details:
On Site/ Remote: Open
Capacity: Fulltime
Start: ASAP
Duration: 5 months with pontential for extension
Language: Englisch: Must Have
German: Nice to have
Your responsibilities:
• Ensuring compliance of IT-related processes within the company in accordance with Good Manufacturing & Distribution Practice (GMP/GDP) requirements;
• Acting as administrator for the IT software systems used in the company (e.g., document management, ERP, validation tools).
• Supporting IT validation activities, including preparing and performing user requirements and performance qualification;
• Maintaining the IT infrastructure (backup and recovery, firewall, VPN, Sharepoint, access rights, Microsoft Office, Windows operating systems);
• Monitoring processes for electronic signatures, cybersecurity, and data integrity;
• Working closely with Quality Assurance and other departments to support regulatory compliance and efficient work processes;
• Creating and reviewing documents related to audits, inspections, deviations, CAPAs, change control, and training;
• Reading and following regulations, German laws, guidelines, and internal SOPs.
Your Qualification:
• At least 2 years of experience in the pharmaceutical industry in a regulated GMP/GDP environment;
• Knowledge of EU GMP Annex 11 and relevant ICH guidelines (Q9, Q10);
• Strong IT skills: electronic document management, IT architecture, IT validations, cybersecurity, VPN/firewall, data migration, databases and meta-information, backups;
• Strong communication skills to explain IT topics to non-technical colleagues, provide IT support, and communicate with regulatory authorities;
Referenznummer: 17028
Branche: Pharma
Beginn des Projekts: 01.02.2026
Dauer: 5 Months
Anstellungsart: Freelance
Kontakt
Antonia Bollow