The Quality Sys Spec is responsible to:
- Support in the setup and maintenance of the distributor and importer Quality system requirements, as described under the Code of Practice for Listed distributors and importers of medical devices for the Hong Kong Service Center
- Attain and hold the wholesale licence(s) for dangerous goods part 1 and psychotropic drugs and perform the role, as stipulated under this licence
- Apply and hold the import licence(s)/certificate(s) for dangerous goods part 1 and psychotropic drugs and perform the role, as stipulated under this licence
- Utilizes critical thinking and problem-solving skills in driving to root cause and corrective actions
- Quality Assurance Related Activities
- Support in the setup and maintenance of the distributor and importer Quality system requirements, as described under the Code of Practice for Listed distributors and importers of medical devices
- Ensures the Quality system and programs meet objectives and comply with all applicable regulations and standards.
- Perform activities related to nonconformance, corrective actions and effectiveness checks.
- Works with service centre personnel to continually improve quality procedures and methods.
- May perform activities related to one or more quality assurance functions including assisting with document inquiries and retrieval of archived documents and records, electronic records, SAP transactions related to Quality Notification.
- Perform audit and oversight of the 3rd party wholesale distributor and importer.
- Perform or support in internal/external audit.
- Draft, revise or obsolete controlled documents (SOPs, WIs, Forms) used at the service centre.
- Regulatory Related Activities
- Support in the necessary wholesaling and import/export licensing activities.
- Ensure accurate dangerous drugs record according to HKSAR regulation.
- Manage and control the operation of drug fulfilment process including physical handling, record keeping and data integrity of the drugs records in Hong Kong.
- Support in pharmacovigilance activities including providing adverse event reporting.
How You’ll Make an Impact:
- Apply and maintain the relevant licenses in Hong Kong for the handling of dangerous goods part 1 and psychotropics and others.
- Find the gap between regulations and current quality management system, work out solutions and implement.
- Oversee and audit the 3rd party vendors to ensure the wholesaling and import licensing activities are covered.
- Setup and maintenance of the distributor and importer Quality system requirements at the Hongkong service centre.
- Be responsible for operational related CAPA plan and perform activities related to nonconformance, corrective actions and effectiveness checks.
- Be responsible for establishment, maintenance and optimization of the local SOPs.
- Perform or support in internal and external audit of quality management system for the service center.
- Organize and conduct quality related training to internal employees and
- Prepares, maintains and updates library or external regulatory standards, reference and guidance documents.
What You Bring:
- Hongkong Registered Pharmacist.
- Minimum bachelor's degree in pharmacy (Hong Kong) or Internal auditor qualification preferred.
- At least 2 years' work experience in Quality Assurance and holding wholesale and/or import license for handling dangerous goods part 1 and psychotropic products. Extensive experience in ISO9001, ISO 13485 &/or GMP.
- Good planning/organizing skills/attention to details.
- Proactive approach to resolving issues.
- Good analytical, communication, problem solving, critical thinking, and computer skills.
- Good working knowledge of regulatory requirements, policies, practices and procedures relating to Quality Assurance.
- Good oral and writing English and Cantonese/Mandarin.
Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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