QC Analyst

QC Analyst

Teva

Troyan, Bulgaria

Our Team, Your Impact

This QC Analyst is responsible for developing, validating, and supporting analytical methods and testing activities for pharmaceutical products, ensuring compliance with regulatory requirements and quality standards throughout product transfer and lifecycle management. The position also prepares analytical documentation for regulatory submissions, collaborates with cross-functional teams, and maintains laboratory operations, equipment, and compliance systems.

How You’ll Spend Your Day

• Develop, validate, optimize, and transfer analytical methods for pharmaceutical products, including preparation of protocols, reports, and supporting documentation;
• Prepare analytical sections of regulatory submissions (CTD format) and support responses to regulatory authority inquiries;
• Perform stability studies, routine analytical testing, and release analyses for pharmaceutical products in compliance with applicable guidelines and regulations;
• Prepare and maintain analytical documentation, including SOPs, specifications, certificates of analysis, validation reports, and laboratory records;
• Operate, maintain, and support qualification of analytical equipment, including preparation of user requirement specifications (URS) for new laboratory instruments;
• Collaborate with cross-functional teams on product transfer projects, regulatory activities, and implementation of new laboratory systems and software;
• Ensure compliance with GMP, pharmaceutical standards, safety procedures, documentation requirements, and laboratory housekeeping practices.

Your Skills and Experience

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field;
• Minimum 1 year of experience in pharmaceutical manufacturing, quality control, analytical development, or a similar laboratory environment;
• Knowledge of analytical method development, validation, stability testing, and pharmaceutical laboratory practices;
• Familiarity with international regulatory requirements and pharmacopoeias, including Ph. Eur., USP, BP, ICH, EMA, and FDA guidelines;
• Proficiency in Microsoft Office and experience working with electronic laboratory and documentation systems;
• Good command of English, both written and verbal;
• Strong problem-solving, collaboration, communication, and organizational skills, with a proactive and results-oriented approach.