6 дней назад
Commercial Quality Senior Specialist (Pharmaceutical Quality)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Commercial Quality Senior Specialist (Pharmaceutical Quality): Managing product acceptance, market release, returns, destruction, temperature assessment, traceability, and distributor qualification in a pharmaceutical quality system with an accent on GxP compliance, regulatory documentation, and 3PL warehouse oversight. Focus on supporting audits and inspections, evaluating quality risks and temperature excursions, improving processes, and implementing digital quality system solutions.
Location: Xian, Shaanxi, China
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of disease prevention, treatment, and care.
What you will do
- Manage product quality acceptance, market release, returned goods, product destruction, temperature assessments, and product traceability.
- Oversee related SOPs, work instructions, records, and activities performed by third-party logistics warehouses.
- Maintain quality documentation, distributor qualification records, training assignments, completion tracking, and training effectiveness evaluations.
- Support internal and external audits, regulatory inspections, observation follow-up, quality risk assessments, issue escalation, and mitigation activities.
- Support GxP computerized systems, including upgrades, validation, and process implementation.
- Drive continuous improvement, data analysis, automation opportunities, digitalization initiatives, and quality system transformation projects.
Requirements
- Bachelor’s degree or higher in pharmacy, medicine, biochemistry, or a related field.
- At least 2 years of experience in the pharmaceutical or related industry; quality and compliance experience is essential.
- Experience or knowledge covering pharmaceutical development, qualification, manufacturing, packaging, validation, testing, release, distribution, GxP, and relevant legislation.
- Strong written and verbal communication skills in both English and the local language are required.
- Strategic thinking, process improvement, project management, multitasking, and advanced Microsoft software and presentation skills.
Nice to have
- Licensed pharmacist qualification.
- Experience with distribution warehouse management.
- Knowledge of audit management, quality management systems, internal controls, regulatory environments, and data analysis.
Culture & Benefits
- Inclusive work environment focused on respecting individual dignity, diversity, and merit.
- Work within a healthcare innovation organization focused on improving patient health outcomes.
- Full-time employment.
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