Assistant Officer – Quality
2 days ago
Assistant Officer – Quality & Regulatory Affairs KLN Pharma is one of the leading pharmaceutical and healthcare distribution, logistics and trading companies in Hong Kong. Our mother company, KLN, is a multinational company listed in the main board in the HIS stock market in Hong Kong with over 26,000 employees across the world. Our company offers intensive training by industrial gurus, university lecturers, as well as corporate and classroom trainings for our sales and marketing teams to equip them with sound business presentation, marketing and writing skills to train up our employees as all-rounded industrial experts in the healthcare and pharmaceutical arenas. Our core expertise falls in the four categories: Pharma & Healthcare, Consumer Goods, Medical Devices and Medical Consumables. KLN Pharma was founded in 2013 and our office is located at the global headquarters of KLN at Kerry Cargo Centre. Responsibilities Assist to perform and maintain QA activities and records for product release, product return and repackaging to ensure the compliance of GMP, GDP, and regulatory requirements. Assist to coordinate and execute process validation; prepare documentations, policy, protocol and report. Assist in establishing and maintaining quality management system and an efficient pharmacovigilance system in compliance with the local authority's regulation and Regional PV policies & SOPs. Provide support in the GMP (repackaging) operation including incoming materials inspection, in-process control and finished product sampling. Support regulatory affairs/product registration related activities. Process documentation of corrective actions plans and monitors implementation. Participate ad hoc project as assigned. Job Requirements Bachelor degree or above in related scientific discipline. 1-2 years of relevant QA experience in food/healthcare products/pharmaceutical industry is preferred. Knowledge in ISO, GDP, GMP and QMS is an advantage. Strong team player, can-do attitude, detail minded, eager to learn, high self-driven to exceed expectations and take up more challenges. Good command of both written and spoken English and Chinese, including Mandarin. If you have the energy and qualifications to add to our velocity, please visit KLN Webpage to apply or send your CV with your present and expected salary to Human Resources & Administration Department by clicking Quick Apply . We are an equal opportunity employer and welcomes applications from all qualified candidates. All personal data will be kept in the strictest confidence and will be used for recruitment purpose only. All applicants may be considered for other suitable positions in KLN. All personal data of unsuccessful candidates will be destroyed. #J-18808-Ljbffr
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