Qualified Person (QP) - Pharmaceutical Industry

За компанијата: „Синцеритас“ АД Скопје е фармацевтска компанија чиј фокус на работење е култивирањето и производството на канабис за медицинска намена. Работните практики и политики во нашата компанија се усогласени со... повеќе за компанијата »

Job Title: Qualified Person (QP) - Pharmaceutical Industry

Job Summary:

As a Qualified Person in the pharmaceutical industry, you will play a critical role in ensuring the safety, quality, and compliance of pharmaceutical products throughout their lifecycle. This position involves certifying batches for release to the market, overseeing quality management systems, and liaising with regulatory authorities to ensure adherence to applicable regulations and standards.

Key Responsibilities:

  1. Batch Certification:
    • Act as the primary point of contact for the certification of medicinal products, ensuring compliance with regulatory requirements and company standards.
    • Review and approve batch documentation, including production records, analytical results, and quality control reports.
  2. Regulatory Compliance:
    • Stay current with relevant regulations, guidelines, and industry standards (e.g., EU GMP, FDA).
    • Interpret and apply regulatory requirements to ensure compliance in all aspects of pharmaceutical manufacturing and distribution.
  3. Quality Management Systems:
    • Oversee and manage the pharmaceutical quality management system (QMS) to ensure its effectiveness and continuous improvement.
    • Conduct regular internal audits to verify compliance with established quality standards.
  4. Collaboration with Cross-Functional Teams:
    • Collaborate with manufacturing, quality control, regulatory affairs, and other relevant departments to ensure a unified approach to quality and compliance.
    • Provide guidance on quality-related matters to different departments.
  5. Product Lifecycle Management:
    • Participate in the product lifecycle management process, including the introduction of new products and variations to existing ones.
    • Ensure that changes are implemented in accordance with regulatory requirements.
  6. Supplier and Vendor Oversight:
    • Collaborate with the procurement and supply chain teams to ensure the qualification and oversight of suppliers and vendors.
    • Assess and manage the impact of changes in the supply chain on product quality and compliance.
  7. Deviation and CAPA Management:
    • Review and assess deviations, out-of-specification results, and non-conformances.
    • Oversee the implementation of corrective and preventive actions (CAPA) to address quality issues.
  8. Training and Development:
    • Provide training on quality and regulatory matters to relevant personnel.
    • Stay informed about industry trends and regulatory updates and disseminate knowledge within the organization.

Qualifications and Experience:

  • Bachelor's or advanced degree in Pharmacy, specialization in quality control or pharmaceutical technology.
  • Qualified Person status in accordance with regional regulations (e.g., Qualified Person Certification in Europe).
  • Extensive experience in a pharmaceutical quality or regulatory role, including batch certification responsibilities.
  • Thorough understanding of cGMP and other relevant regulations.
  • Strong analytical, decision-making, and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Experience with regulatory inspections and interactions.

Additional information: Candidates who meet the above conditions can send their CVs to email:  [најави се за да го видиш е-маилот]

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