Job Description

  • Department: Quality Control and Quality Assurance
  • Employment Type: Full-time
  • Education: Master's degree or PhD in Chemistry, Pharmacy, Biology, or related scientific field
  • Work Experience: Minimum 5+ years in pharmaceutical QC laboratory environment
  • Location: Borongajska cesta 83H, 10000 Zagreb

Responsibilities

  • Independently perform complex quality control testing of raw materials, APIs, in-process samples, and finished products using HPLC, GC, LC-MS/MS, dissolution, and other advanced techniques
  • Develop, optimize, and validate analytical methods according to ICH guidelines and pharmacopeial standards
  • Review and approve analytical data, laboratory records, and test reports for compliance and accuracy
  • Lead laboratory investigations for out-of-specification (OOS) results, deviations, and CAPA implementation
  • Train and mentor junior analysts on analytical techniques, GMP documentation, and compliance requirements
  • Manage instrument qualification (IQ/OQ/PQ), calibration, and maintenance programs
  • Support stability studies, method transfers from R&D, and analytical technology transfers
  • Prepare and review SOPs, validation protocols, and technical reports for regulatory submissions
  • Represent QC department during internal audits, client audits, and regulatory inspections
  • Identify and implement process improvements and laboratory efficiency initiatives
  • Collaborate with QA, R&D, and Production teams on quality issues and product lifecycle management

Requirements

  • Master's degree or PhD in Chemistry, Pharmacy, Biology, or related scientific field
  • 5+ years of hands-on experience in pharmaceutical QC laboratory with analytical method execution and validation
  • Advanced expertise in HPLC, GC, LC-MS/MS, dissolution, and other pharmaceutical analytical techniques
  • In-depth knowledge of GMP, GLP, ICH guidelines, USP/EP pharmacopeias, and ISO 17025
  • Proven experience leading laboratory investigations (OOS, OOT, deviations) and CAPA processes
  • Strong technical writing skills for protocols, reports, and regulatory documentation
  • Experience with laboratory information management systems (LIMS) and electronic data management
  • Excellent problem-solving skills and attention to detail in a fast-paced, regulated environment
  • Leadership experience training and mentoring laboratory staff
  • Fluent English communication skills (written and verbal)
  • Ability to work independently and manage multiple priorities effectively

What We Offer

  • Leadership role in a state-of-the-art pharmaceutical QC laboratory
  • Opportunity to work with cutting-edge analytical instrumentation and technologies
  • Significant responsibility in method validation, investigations, and regulatory compliance
  • Career progression opportunities within Quality Control and Laboratory Management
  • Competitive salary, performance bonuses, and comprehensive benefits package
  • Regular professional development including specialized training and conferences

If you have extensive pharmaceutical QC experience and want to take ownership of complex analytical challenges in a dynamic laboratory environment, we want to hear from you!