обновлено 11 дней назад
Quality & Validation Specialist (Chemistry)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality & Validation Specialist (Chemistry): Executing and documenting validation, qualification, analytical testing, and quality activities in a regulated medical device or pharmaceutical manufacturing environment with an accent on GMP, ISO, FDA, EMA, and data integrity compliance. Focus on investigating deviations and OOS results, performing root cause analysis, supporting CAPA, and interpreting HPLC, GC, UV, and FTIR data.
Location: On-site in Dublin, Ireland
Company
develops functional coatings, adhesives, and sealants for customers across more than 30 market segments and over 140 countries.
What you will do
- Execute and document process, cleaning, analytical method, and equipment validation activities.
- Support equipment and system qualification using IQ/OQ/PQ protocols.
- Prepare and review validation protocols, reports, risk assessments, and quality documentation.
- Investigate deviations, non-conformances, and out-of-specification results; perform root cause analysis and support CAPA effectiveness reviews.
- Interpret analytical data from HPLC, GC, UV, and FTIR techniques.
- Support audits and inspections while collaborating with Quality, Laboratory, and Operations teams on continuous improvement.
Requirements
- Bachelor's degree in Chemistry or a related scientific discipline.
- 2–5 years of experience in pharmaceutical, medical device, or regulated manufacturing environments.
- Hands-on experience with process, cleaning, analytical, or equipment validation.
- Knowledge of GMP, ISO 13485, FDA, or EU regulatory requirements.
- Strong technical writing, documentation, and problem-solving skills.
Nice to have
- Postgraduate qualification or certification in Quality, Validation, or a related field.
- Experience supporting FDA or Notified Body inspections.
- Knowledge of FMEA, Fishbone, or 5 Whys risk management tools.
- Experience with electronic Quality Management Systems and familiarity with automation testing, scripting, or GAMP5 frameworks.
Culture & Benefits
- Collaborative work across Quality, Laboratory, and Operations functions.
- Exposure to regulated medical device or pharmaceutical manufacturing processes.
- Work supporting GMP, ISO, FDA, EMA, and data integrity compliance.
- Equal employment opportunity and an inclusive workplace culture.
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