Quality Assurance Associate

vor 4 Wochen

Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

Are you a qualified professional looking for a challenging role in quality assurance and compliance? We at GULP – experts united are seeking an experienced Employee Quality & Compliance to join our team in the pharmaceutical industry.


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
  • Conduct risk-based evaluations of batches produced and coordinate root cause analysis and action tracking with relevant interface partners
  • Maintain the internal release system (SAP-based) for digital storage of all batches produced
  • Independently create deviation reports in collaboration with relevant interface partners
  • Coordinate, process, and update internal manufacturing regulations with all relevant interface partners
  • Create SOPs and specification documents
  • Train employees in compliance with the applicable quality management system
  • E nsure correct filing and archiving of records and documents in accordance with valid specifications
  • Independently create and maintain change requests (equipment) in the area and coordinate necessary actions in accordance with applicable specifications
  • Accompany tours of production areas
  • Check hygiene measures (hygiene plans) and follow up on actions resulting from monitoring limits being exceeded

Requirements:



  • Degree in natural sciences (Master's degree in chemistry preferred)
  • 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 relevant DIN ISO standards (13485, 9001) and other regulations (e.g. GMP, IVDD, FDA QSReg)
  • Experience in process analysis, qualification, and validation
  • Fluent German and good written and spoken English skills

We offer:



  • Attractive salary package with Christmas and vacation bonuses
  • Reimbursement of travel expenses
  • Up to 30 days vacation per year
  • Further training through e.Learning offers
  • Open corporate culture

About Us:


We are a dynamic team of experts united, committed to providing exceptional service and quality solutions to our clients. We believe in fostering a positive work environment that encourages growth, innovation, and collaboration.


Join Our Team:


We are seeking a highly skilled and motivated individual to join our team as an Employee Quality & Compliance. If you are passionate about quality assurance and compliance, and have a strong desire to work in a fast-paced and dynamic environment, we encourage you to apply.


How to Apply:


Please submit your application, including your resume and cover letter, to us. We look forward to hearing from you.

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