Meyer Pharmaceuticals Ltd
QA Officer/Assistant
A week ago
Job Duty
-Handle all regulatory issues and dossier preparation of product registration. -Maintain the local product registrations through timely renewal of product certificates and life cycle management. -Ensure that all new products are registered by the local regulations and company policy in a defined timeline. -Liaise with external bodies in regulatory affairs issues such as Department of Health and Hospital Authority. -Ensure the application is in line with local and international regulations. -Coordinate and monitor artwork / packaging process of various products -Provide RA support to New Product Development Team; Tender Team by compiling tender documents; Marketing Team by reviewing of marketing materials in accordance with local authorities and Undesirable Medical Advertisement Ordinance (UMAO) -Communicate with oversea counterpart for necessary dossiers and licences for submissions -Training, proficiency, familiarity and application of SOP for all critical tasks/duties e.g. regulatory filings, artwork preparations etc. -Maintain good record, databases, filing system of product registration and licenses -Maintain MA / license applications for all existing products -Ensure regular tracking of DoH system for any new deficiencies or CORP enquiries -Maintain excellent communication and relation with related external and internal parties -Onsite tasks ___ Higher Diploma or above Minimum 1 years of Regulatory experience in Pharma and Regulated industry Experience in registration of medicinal products locally Good command in written and spoken English and Chinese Good communication skills, organizational skills and interpersonal skills Positive working attitude and a team player You will have an advantage if you are/ have With basic knowledge in pharmacovigilance, QA With experience in negotiating with regulatory authorities
Allowance & Benefit
Other
Free staff product
Timetable
Mon to Sat
08:45 - 17:45
Alternate Saturday work is required
Requirement
Education:
Diploma / Certificate
Skill:
Microsoft Word
Microsoft Excel
Language:
Spoken Skill
Mandarin
English
Cantonese
Written Skill
English
Chinese
About Company
美亞製藥是一間香港西藥廠,具有35年歷史,在香港排名前5,藥廠已經通過PICS認證。