Quality Leader at Halborn

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Direct administrative reporting to the company leader and business reporting to the quality leader
Knowledge of national drug quality policies, laws, regulations, and administrative rules, including GSP (Good Supply Practice), Drug Administration Law, and related implementation rules
Expertise in drug quality management, including auditing first-time suppliers and products, quality acceptance, inspection, and handling quality issues
Ability to guide and supervise quality management across procurement, storage, maintenance, sales, returns, and transportation
Proficiency in quality information management, complaint handling, product recalls, adverse reaction reporting, and computer system quality controls
Skills in organizing training on pharmaceutical knowledge, quality laws, and regulations
Capability to conduct verifications, calibrations, audits, and risk assessments for quality management systems

Responsibilities

Fully implement national drug quality policies, laws, regulations, and rules, and propose implementation measures
Organize formulation, revision, and perfection of the company quality management manual and systems based on GSP; implement, supervise, assess, and report to the quality management leadership group after approval
Ensure GSP implementation in the company and coordinate inter-departmental quality issues, reporting to the leadership group as needed
Guide quality audits for first-time suppliers and products, sign off on approval forms, verify supplier quality systems, and ensure drugs are from legitimate sources
Guide establishment and maintenance of quality files for operated drugs
Guide drug quality acceptance and inspection work
Guide and supervise quality management in procurement, storage, maintenance, sales, returns, and transportation
Collect, organize, and report quality information per regulations; disseminate to relevant departments, especially for problematic products, ensuring strict quality controls in storage
Guide handling of quality inquiries and complaints per regulations: consult manufacturers, provide responses, handle returns/exchanges, inspect at drug testing institutes, report counterfeit drugs to authorities, and maintain records
Guide maintenance of drug codes and collection of storage drug data in computers
Review and participate in confirmation, reporting, write-off, and destruction of unqualified drugs
Assist quality leader in organizing quality analysis meetings to address problematic drugs
Provide internal quality technical consultation and guidance; plan and conduct training on pharmaceutical basics, quality laws (e.g., Drug Administration Law, GSP), for employees
Guide setting of computer system quality controls and operation permissions: set functions, review permissions, supervise operations, audit/enter/lock quality data, review data modifications, handle system quality issues
Manage drug recalls
Report, collect, and organize drug adverse reactions
Organize verification and calibration of related facilities and equipment
Organize personnel for quality management system audits and risk assessments

Skills

GSP

Quality Management

GMP

Quality Assurance

Quality Control

Drug Inspection

Quality Auditing

Regulatory Compliance

Pharmaceutical Quality

Quality Archiving

Complaint Handling

Risk Management

Halborn

Cybersecurity for blockchain and digital assets

About Halborn

Halborn specializes in cybersecurity focused on blockchain technology and digital assets. The firm provides security audits, penetration testing, and consulting services to clients in the digital finance sector, including cryptocurrency exchanges and Decentralized Finance (DeFi) companies. Their services help ensure the security of digital assets and financial infrastructure by addressing the specific security threats associated with blockchain technology. Halborn stands out from competitors due to its deep understanding of both blockchain and traditional financial security, which allows them to offer tailored solutions. The company's goal is to protect businesses from security threats, ensuring the safe operation of digital exchanges and the integrity of smart contract infrastructure.

Miami, FloridaHeadquarters

2019Year Founded

$87.5MTotal Funding

SERIES_ACompany Stage

Cybersecurity, Financial ServicesIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Company Equity

Risks

Increased targeting of Bitcoin hot wallets poses risks to Halborn's clients.

AI-powered social media bot farms could introduce new cyber threats.

Ongoing vulnerabilities in smart contracts remain a challenge for Halborn's services.

Differentiation

Halborn specializes in blockchain and digital asset cybersecurity, setting it apart.

The company offers high-level security audits and penetration testing for DeFi clients.

Halborn's expertise in both blockchain and traditional finance security is unique.

Upsides

Growing demand for blockchain security boosts Halborn's market potential.

Partnerships with Tholos and Orion Protocol enhance Halborn's Web3 security reputation.

Tokenized real-world assets present new opportunities for Halborn's security solutions.

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