Unison Group

Healthcare Quality & Regulatory Compliance, Senior Specialist

Unison Group  •  Seoul, KR (Onsite)  •  3 days ago
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Job Description


1. Regulatory & Quality Compliance

• Ensure compliance with Korean healthcare / pharmaceutical regulations ( Eg KGSP)

• Approve incoming / released/returned products through specification and visual checks

• Maintain and update key quality documents ( Quality Manual, SOP, WI)

• Conduct internal audits and oversee environmental hygiene

• Interpret regulatory standards and ensure process compliance

2. Training Management

Develop and deliver regulatory / quality training programs for employees

3. Quality Issue Management

• Report and manage suspected counterfeit or adulterated products

• Investigate and improve QMS issues ( Change Control, Deviation, CAPA)

• Record and monitor quality issues to prevent recurrence

Job Requirements / qualifications

• Knowledge and practical experience related to the medicines Act

• Experience with  ISO integrated management systems

• Internal audit and quality system enhancement  experience

• Experience in delivery / transportation service quality management

• Practical understanding of KGSP and regulatory standards

• QMS operation and quality documentation management skills

• Audit and problem solving capabilities ( including CAPA /SOP optimisation )

• Training design and delivery skills

• Strong cross functional communication and collaboration

• Fluent or intermediate level in Korean and English as the role required to communicate with overseas counter part and reporting to overseas manager

• Possess valid local Pharmacist License

Working hours:

Mon to Fri 9am-6pm
Unison Group

About Unison Group

Unison Consulting was launched in Singapore on September 2012, the hub of the financial industry, with innovative visions in the technocratic arena. We are a boutique next-generation Technology Company with strong business-interests in Liquidity risk, Market Risk, Credit Risk and Regulatory Compliance.

Unison provides technology consulting and services to implement Risk Management and Risk Analytics System for Financial Institutions. Our services suite comprises of Techno-Functional consulting, systems integration, Business Intelligence, information management, and custom development of IT solutions, plus project management expertise for financial institutions.

We have expertise in latest cutting edge technology to achieve better total cost of ownership. Through our qualified professionals, we assist you drive your unique risk management strategies, whether that means efficient monitoring, improving risk appetite of the financial institutions, complying with regulations, or capturing growth opportunities through innovation, this is what maximizes your decision taking potential. At Unison Consulting, we view clients as partners, and our success is only measured by the success of our partners. So we put it all on the table in order to exceed expectations.

Our staff consists of young, energetic and innovative consultants who are never afraid to challenge the conventions and push the boundaries in an effort to help our clients. For every project, no matter how large or how small, we strive to not only meet your needs, but deliver a showcase in your field.

Industry
IT & Software
Company Size
51-200 employees
Headquarters
Unknown
Year Founded
2012
Website
com.sg
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