Position Summary:The QA Specialist will be responsible for ensuring that pharmaceutical products meet quality standards and regulatory requirements. This role involves conducting inspections, reviewing documentation, and implementing quality systems in line with GMP (Good Manufacturing Practice) and EU regulatory guidelines. The QA Specialist will collaborate with various departments, including production, R&D, and compliance, to maintain high-quality standards throughout the manufacturing process.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.