Sr. specialist, Lab Support

Principle Roles & Responsibilities

The role involves supporting Quality Control (QC) business through digital system deployment, laboratory testing, and equipment lifecycle management.

• Digital Systems: Deploy and manage end-to-end processes for systems like BIOVIA (Electronic Lab Notebook), LIMS, Labx, Empower, and SAP. Utilize Quality by Design (QbD) principles to ensure GMP and Data Integrity compliance.
• Laboratory Testing: Perform analysis on packaging, excipients, finished products, and environmental samples. Support investigations into OOS, OOT, and OOE issues, and assist in GMP self-inspections and audits.
• Equipment Management: Oversee the lifecycle of laboratory instruments, including validation, calibration, maintenance, and decommissioning.

Qualifications and Experience

• Bachelor’s degree or higher in Pharmacy, Chemistry, Biochemistry, Microbiology, or equivalent.
• At least 4 years of relevant experience in laboratory analysis or QC digital deployment within the pharmaceutical industry.
• Strong understanding of GMP and Pharmacopeia (ChP, EP, USP) standards.
• Proficiency in laboratory electronic system management, project management, and instrument maintenance.
• Good English listening and speaking skills.