5 дней назад
Commercial Quality Associate Manager (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Commercial Quality Associate Manager (MedTech): Managing commercial quality and GSP compliance activities for pharmaceutical products in Xi'an with an accent on market release, audits, risk management, and regulatory requirements. Focus on optimizing quality systems, validating computerized systems, managing licenses, and deploying digital solutions to improve compliance and operational efficiency.
Location: Xi'an, Shaanxi, China
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions aimed at preventing, treating, and curing complex diseases.
What you will do
- Manage market release activities in line with applicable regulations and internal quality requirements.
- Lead GSP internal audit management and support internal and external audits, regulatory inspections, and observation follow-up.
- Manage GSP quality risks, product quality assessments, issue escalation, and mitigation activities.
- Maintain GSP quality systems, including SOP and work-instruction management, and monitor effective operation.
- Manage GSP computerized systems and support GxP system upgrades, validation, and process implementation.
- Manage GSP licenses, support digitalization and quality transformation projects, and drive continuous improvement.
Requirements
- Licensed pharmacist certification is mandatory.
- Bachelor's degree or higher in pharmacy, medicine, biochemistry, or a related field.
- At least 3 years of experience in the pharmaceutical or related industry is preferred; quality and GxP compliance experience is essential.
- Strong written and verbal communication skills in the local language and English.
- Expert knowledge of Microsoft software and presentation tools.
- Knowledge of pharmaceutical development, manufacturing, packaging, validation, testing, release, distribution, pharmaceutical legislation, and GxP.
Nice to have
- Experience with distribution warehouse management.
- Audit management, quality control, QMS, regulatory environments, ISO 9001, data analysis, and continuous improvement.
Culture & Benefits
- Inclusive work environment that respects employee diversity, dignity, and individual merit.
- Opportunity to contribute to quality system transformation, process optimization, automation, and digital solution deployment.
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