(KLN Pharma) QA RA Senior Manager

Business Unit

Job Role

Job Summary

Key Responsibilities

Education Preferred

Professional Qualifications Required

Required Work Experience

English

Cantonese

Mandarin

KLN PHARM

Senior Manager - Quality & Regulatory Affairs

The senior role plays a critical leadership role in ensuring that all pharmaceutical products meet regulatory requirements and quality standards. This position oversees QA systems, manages regulatory submissions, and ensures compliance with international as well as local standards. This role is also important for collaboration with cross-functional teams to achieve QA and RA goals for the business.

• Liaise with Drug office and Medical Device Division on registration, listing, licensing and other legal affairs
• Lead and assure the operation of secondary packaging under appropriate regulations
• Overview, supervise and manage the registration and renewal of pharmaceutical, medical device as well as tender applications for drugs and medical devices
• Establishes procedures and policies to ensure that the quality system meets the requirements of standards required for the business, such as ISO 13485 and GDP certification
• Monitor and maintain documentations, regulatory records and databases to ensure all licenses compliance the regulatory and Company’s requirements
• Collaborate with cross-functional teams including operation and risk management personnel in formulating and establishing quality policies and goals according to standards required for the business
• Maintain an efficient pharmacovigilance system compliance with local authority's regulation Regional PV policies & SOPs
• Lead and supervise the QA/RA team
• Manage ad hoc project as assigned
• Other duties as assigned by General Manager

Bachelor’s degree in pharmacy and registered with Hong Kong Pharmacy and Poison Board as a Pharmacist

registered with Hong Kong Pharmacy and Poison Board as a Pharmacist

5-10 years

Excellent

Excellent

Excellent