Quality Assurance Specialist

vor 2 Wochen

Berlin, Berlin, Deutschland SciPro Vollzeit
Job Title: Quality Assurance Specialist

SciPro is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our pharmaceutical products meet the highest quality standards and regulatory requirements.

Key Responsibilities:
  • GMP Compliance: Ensure compliance with GMP regulations, including audits, inspections, and regulatory submissions.
  • Quality Control Oversight: Review and approve batch records, change controls, deviations, CAPAs (Corrective and Preventive Actions), and validation protocols.
  • Internal Audits: Conduct and participate in internal audits to ensure compliance with both company standards and regulatory requirements.
  • Document Control: Maintain and review Standard Operating Procedures (SOPs) and ensure proper documentation of all quality-related processes.
  • Risk Management: Support risk assessments and manage quality risk in processes and production.
  • Training: Provide quality-related training to staff to ensure compliance and awareness of quality standards.
  • Supplier Quality Management: Collaborate with procurement and suppliers to manage supplier quality audits and ensure raw materials meet company standards.
  • Complaint Management: Assist in the investigation and resolution of customer complaints regarding product quality.
  • Continuous Improvement: Identify and implement process improvements in quality assurance and control systems.
  • Regulatory Compliance: Stay up-to-date with local and EU regulations affecting pharmaceutical manufacturing, ensuring company compliance.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
  • Minimum of 3-5 years of experience in Quality Assurance in the pharmaceutical or biotech industry.
  • Strong knowledge of GMP, EU regulations, and quality systems.
  • Experience with audits and regulatory inspections.
  • Excellent organizational, communication, and interpersonal skills.
  • Proficiency in German and English (both written and spoken).
Desired Skills:
  • Experience with quality management systems (QMS).
  • Familiarity with electronic document management systems (EDMS).
  • Strong analytical and problem-solving skills.
  • Experience with root cause analysis and risk assessment tools.

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