Annette Williamson
Moulton,AL
Summary
Experienced Quality Assurance Specialist with 10+ years in GMP compliance, internal/external audits, deviation investigations, and CAPA management. Known for strong documentation, analytical thinking, and process improvements that support product quality and inspection readiness.
Proven ability to resolve quality issues, maintain compliance, and improve quality systems through clear documentation and cross-functional teamwork.
Detail-oriented professional with a strong background in quality systems, internal audits, and regulatory compliance.
Overview
20
20
years of professional experience
Work History
Quality Assurance Specialist
Chemische Fabrik Kreussler & Co. GmbH
Wiesbaden, Germany
08.2012 - 05.2022
- Led deviation investigations, documented root causes, and tracked corrective actions through CAPA completion.
- Coordinated change control reviews to ensure process updates met regulatory and validation requirements.
- Reviewed batch records and release documentation for compliance with GMP and internal quality standards.
- Audited SOPs and quality documents, maintaining accuracy and alignment with current manufacturing practices.
- Supported internal and external inspections by preparing records, responses, and follow-up actions.
- Monitored quality trends, identified recurring issues, and recommended process improvements.
- Collaborated with cross-functional teams to resolve nonconformances and maintain consistent product quality.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Maintained up-to-date knowledge of regulatory changes, ensuring product compliance across multiple markets.
- Led GMP-compliant quality reviews for batch records, deviations, and release documentation.
- Supported internal and external audits with inspection-ready records and evidence.
- Trained staff on quality standards, hygiene requirements, and documentation practices.
Pharmaceutical Technician
Bergheimer Apotheke
Heidelberg, Germany
04.2002 - 08.2005
- Prepared prescription medications accurately, following pharmacy protocols and dosage requirements.
- Supported pharmacists with prescription processing, labeling, and documentation tasks.
- Verified medication stock, expiration dates, and storage conditions to maintain compliance.
- Advised customers on over-the-counter products and proper medication use.
Education
Diplom Ingenieur Biopharmazeutische Technologie - Biopharmazeutische Technologie
Technische Hochschule Mittelhessen
Giessen, Germany04-2012
Advanced Technical College Entrance Qualification - Health
Hans-Viessmann-Schule
Bad-Wildungen, Germany06-2006
Pharmazeutisch-Technische-Assistentin -
Deutschen-Angestellten-Akademie
Marburg, Germany03-2002
Skills
- Quality assurance
- Quality improvements
- Internal audits
- External audits
- Audit reports
- Reporting documentation
- Policy establishment
- Action planning
- Detail-oriented
- Problem-solving skills
- Analytical thinking
- Documentation skills
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Languages
English
Professional Working
German
Native or Bilingual
Interests
Gardening
Yoga
Timeline
Quality Assurance Specialist
Chemische Fabrik Kreussler & Co. GmbH
08.2012 - 05.2022
Pharmaceutical Technician
Bergheimer Apotheke
04.2002 - 08.2005
Diplom Ingenieur Biopharmazeutische Technologie - Biopharmazeutische Technologie
Technische Hochschule Mittelhessen
Advanced Technical College Entrance Qualification - Health
Hans-Viessmann-Schule
Pharmazeutisch-Technische-Assistentin -
Deutschen-Angestellten-Akademie