5 дней назад
Senior Associate Quality Assurance Specialist (Pharmaceutical)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Associate Quality Assurance Specialist (Pharmaceutical): Managing and improving quality management systems at the KSP facility and associated contractor sites with an accent on CAPA, deviations, change control, complaints, audits, and GMP compliance. Focus on leading root cause analysis, coordinating quality events, authoring QMS documentation, and presenting quality metrics for management review.
Location: Sittingbourne, United Kingdom
Company
is a global biopharmaceutical company developing medicines for serious diseases, including sleep disorders, epilepsy, and cancer.
What you will do
- Support the Quality Compliance Manager and QA team in implementing quality systems at the KSP facility and contractor sites.
- Manage CAPA, deviations, change control, supplier and customer complaints, and quality risk management processes.
- Lead root cause analyses and facilitate the timely closure of quality events and complaints.
- Coordinate with global process owners to maintain consistency across quality systems, sites, and functions.
- Prepare QMS documents, SOPs, training packages, technical agreements, supplier agreements, and quality risk assessments.
- Compile QMS metrics and KPI data and present them at quality management review meetings.
Requirements
- Bachelor’s degree in science or a related discipline.
- At least 3 years of relevant experience in the pharmaceutical, biotechnology, or related industry.
- Experience working in a quality environment with GMP, GACP, and GDP.
- Strong written and verbal communication skills.
- Working knowledge of office IT packages.
- Ability to work at the Sittingbourne, UK facility.
Culture & Benefits
- Work within a patient-focused and science-driven biopharmaceutical organization.
- Collaborate with global process owners and quality teams across multiple sites and functions.
- Participate in projects focused on productivity and efficiency improvements.
- Fixed-term contract for 12 months.
- Equal opportunity workplace.
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