Freelancer profile translated to English.

Description

I support companies in regulated industries with GMP/Quality Documentation, SOPs, CAPA/Deviation Management, and Audit Preparation.

Through my experience in quality control, laboratory environments, and GMP/ISO 17025-related processes, I am familiar with the practical requirements for clean documentation, traceable testing processes, and audit-ready records. I work in a structured, meticulous, and solution-oriented manner – with a clear focus on quality, compliance, and practical applicability.

Typical projects I can support:

• Creation, review, and revision of SOPs and work instructions

• Support with deviations, CAPA measures, and change control documentation

• Preparation of audit documentation and quality documents

• Review of test protocols, batch records, and QC documentation

• Setup of simple Excel trackers for CAPA, deviations, test status, or quality metrics

• Support with laboratory processes, document control, and quality management

I bring experience from quality control, laboratory analytics, regulated production environments, and documentation-intensive processes. Clear communication, reliable processing, and documents that are not only formally correct but can actually be used in daily work are particularly important to me.

I work in German and English and support projects remotely or hybrid.

Industry field of expertise

Languages

German
Fluent
English
Native or bilingual
Russian
Native or bilingual
Turkish
Native or bilingual

Workplace preferences

Can work on-site

Cuxhaven (up to 50km)

VOCO GmbH
Quality Control Specialist
December 2024 - Today (1 year and 7 months)
Cuxhaven, NI, Germany
• - Perform quality control testing within a regulated manufacturing environment
• - Document test results according to controlled quality procedures and SOPs
• - Support deviation documentation and quality investigations
• - Ensure compliance with regulatory and internal quality standards
• - Perform functional testing of dental medical devices and verify performance parameters
• - Contribute to audit-ready documentation and quality system improvements
SOP Creation & Document Review Audit Preparation
LAVES
Laboratory Quality / Environmental Radioactivity
July 2024 - December 2024 (5 months)
Lower Saxony, Germany
• - Supported environmental radioactivity monitoring within a regulatory authority framework
• - Participated in ISO 17025 audit preparation and accreditation-relevant activities
• - Evaluated measurement results in environmental monitoring context
• - Supported compliance-sensitive laboratory workflows and reporting
• - Collaborated with IMIS environmental monitoring network and authorities
• - Contributed to environmental data evaluation and technical reporting
Elanco
Production Operator
November 2022 - July 2024 (1 year and 8 months)
Cuxhaven, NI, Germany
• - Worked in GMP-regulated cleanroom environments (Class A–C)
• - Maintained strict compliance with safety and quality requirements
• - Executed GMP documentation and batch record handling
• - Supported deviation documentation and investigations
• - Performed hygienic monitoring and filter integrity testing
• - Contributed to controlled pharmaceutical manufacturing processes