Job Description

Roles & Responsibilities

Conduct routine and non-routine analyses of in-process materials, finished goods, and stability samples in a timely manner. Interpret test results and compare them with established specifications and control limits. Conduct chemical and physical laboratory tests to perform qualitative and quantitative analyses. Complete documentation required to support testing activities, including data capture forms, equipment logbooks, and inventory records. Ensure compliance with Data Integrity principles and Good Documentation Practices (GDP) in all laboratory activities. Prepare technical reports, graphs, and charts to document experimental results. Participate in out-of-specification (OOS), out-of-trend (OOT), and laboratory failure investigations. Provide quality control data required for regulatory submissions, as applicable. Investigate and report questionable or atypical test results to the supervisor. Perform data entry and trend analysis activities. Execute activities related to process validation, cleaning validation, and instrument qualification under supervision, as applicable. Support the preparation and execution of SOPs, calibration protocols, validation protocols, and qualification documents (IQ, OQ, and PQ) related to laboratory activities. Ensure implementation of Viatris Policies and requirements applicable to laboratory operations. Monitor reference standards inventory and expiry status. Monitor inventory and expiry status of laboratory stock items, including reagents, glassware, filters, and other laboratory consumables. Support the review and revision of Quality Control SOPs, as assigned. Participate in continuous improvement initiatives, including Lean and Six Sigma projects. Support QC compliance activities related to Viatris Policies, internal audits, EDA actions, and data integrity requirements.

Desired Candidate Profile

Working knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP), with particular emphasis on Quality Control operations. Knowledge of analytical laboratory techniques and laboratory instrumentation, including pH meters, UV-Visible spectrophotometers, High-Performance Liquid Chromatography (HPLC), and reagent preparation. Familiarity with laboratory investigations, data integrity requirements, and Good Documentation Practices (GDP) is preferred. Experience with laboratory computerized systems and electronic data management is an advantage. Knowledge of pharmaceutical testing requirements, specifications, and regulatory expectations is preferred.

Minimum Qualifications for this Role

• Bachelor's degree in Pharmacy, Chemistry or Pharmaceutical Sciences.
• 1 2 years of experience in a pharmaceutical Quality Control laboratory.
• Good command of the English language, both written and spoken.
• Strong technical writing, documentation, and communication skills.
• Proficiency in Microsoft Office applications (Word, Excel, and PowerPoint).
• Strong organizational, analytical, and problem-solving skills, with the ability to work independently and effectively within a team environment.
• Ability to manage multiple priorities, work under pressure, and meet deadlines.