Quality Assurance Manager/Qualified Person at Halborn

Warsaw, Masovian Voivodeship, Poland

Halborn Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Consumer Health, PharmaceuticalsIndustries

Requirements

  • Expertise in Quality Management Systems (QMS), GMP, GDP, and regulatory requirements
  • Ability to act as Qualified Person (QP) for batch assessment, release, and certification of imported and repackaged products
  • Knowledge of Haleon standards, policies, and Guide for Commercial Companies
  • Experience in overseeing warehouse operations for importer and manufacturer, including commercial repackaging
  • Safeguarding licensing compliance for warehousing and import activities
  • Familiarity with Technical Terms of Supply (TTS), Distribution Risk Assessments, and Quality Agreements
  • Experience liaising with manufacturing sites, External Supply (ES), Third Party Suppliers (3PL), and logistic operators

Responsibilities

  • Develop, specify, and approve processes and systems impacting product quality in line with QMS and local regulatory requirements
  • Review and approve TTS, liaise with manufacturing sites for compliance to local registered technical details, including Distribution Risk Assessments for products from manufacturing sites, Multimarket Warehouse (MMW), or local warehouse
  • Liaise with External Supply (ES) Quality for contractor-manufactured products, review and approve Quality Agreements per product per ES
  • Ensure 3PLs providing GxP services are audited by central functions and have Quality Agreements in place
  • Perform routine checks on validity of local GDP/GMP Licenses for 3PLs and third-party distributors
  • Liaise with MMW/local Logistic Operators to ensure mandatory 3PL CERPS QA Controls are in place and controlled
  • Ensure LOC processes and systems for receipt, storage, returns, warehousing of products (medicines, medical devices, cosmetics, food, nutritional, toothbrushes) comply with Haleon QMS
  • Work with supply chain organization to approve changes to GxP activities via Change Control
  • Lead local batch assessment and release for imported products as Qualified Person
  • Oversee warehouse for importer and manufacturer, manage release of imported goods, and certify product batches including repackaged batches
  • Participate in cross-country projects within CEE region

Skills

GMP
GDP
Quality Assurance
Batch Release
Regulatory Compliance
Warehousing
Import Compliance
Product Certification
Repackaging

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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