Quality Assurance Specialist

vor 4 Wochen

Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

Are you a detail-oriented professional with a passion for quality and compliance? Do you have experience in the pharmaceutical industry and a strong understanding of regulatory requirements? We are currently looking for an Employee Quality & Compliance Specialist to join our team at GULP – experts united.

Key Responsibilities:

  • Support the Group Manager and other managers on issues related to Quality & Compliance
  • Prepare the internal batch record review in consultation with the responsible product group manager
  • Prepare the risk-based evaluation of batches produced and coordinate the root cause analysis and action tracking in the event of deviations with the involvement of all relevant interface partners
  • Maintain the internal release system (SAP-based) for the digital storage of all batches produced
  • Independently create deviation reports in collaboration with the relevant interface partners
  • Coordinate, process, and update internal manufacturing regulations in collaboration with all relevant interface partners
  • Create SOPs and specification documents
  • Train employees in compliance with the applicable quality management system
  • Ensure the correct filing and archiving of records and documents in accordance with the currently valid specifications
  • Independently create and maintain change requests (equipment) in the area and independently coordinate all necessary actions in accordance with the applicable specifications
  • Accompany tours of the production areas
  • Check hygiene measures (hygiene plans) and follow up on actions resulting from monitoring limits being exceeded

Requirements:

  • Degree in natural sciences (preferably a Master's degree in chemistry)
  • Professional experience in the pharmaceutical or chemical industry
  • Experience in or understanding of production and quality control processes and general business practices within the regulated diagnostic/pharmaceutical industry
  • Knowledge of the relevant DIN ISO standards (13485, 9001) and other relevant regulations (e.g. GMP, IVDD, FDA QSReg)
  • Experience in process analysis, qualification, and validation
  • Fluent German and good written and spoken English skills

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