Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or another Life Sciences discipline.
At least 5 years of Quality Assurance or In-Process Quality Assurance experience within a pharmaceutical manufacturing environment.
Direct experience supporting sterile injectable manufacturing operations.
Extensive experience in shop-floor quality assurance, including in-process inspections and real-time oversight of manufacturing activities.
Strong understanding of aseptic processing principles and sterile manufacturing regulations.
Proficiency in reviewing Batch Manufacturing Records (BMRs) and Batch Production Records (BPRs) for accuracy and compliance.
Hands-on experience with batch record review and document control in a regulated pharmaceutical setting.
Knowledge of current Good Manufacturing Practices (cGMP) and their application in sterile manufacturing.
Familiarity with sterile filtration and lyophilization processes within pharmaceutical production.
Experience performing and overseeing line clearance activities in manufacturing and packaging areas.
Experience supporting investigations for deviations, out-of-specification (OOS) results, and manufacturing events.
Understanding of Corrective and Preventive Action (CAPA) management and root cause analysis methodologies.
Commitment to Good Documentation Practices (GDP) and Data Integrity principles (ALCOA+).
Knowledge of FDA 21 CFR Parts 210 and 211 and their application to sterile pharmaceutical manufacturing.
Familiarity with EU GMP Annex 1 requirements for sterile medicinal products.
Experience with aseptic manufacturing practices, including gowning, aseptic behaviors, and cleanroom discipline.
Exposure to environmental monitoring programs and interpretation of environmental data.
Experience performing or overseeing visual inspection of sterile products.
Knowledge of line clearance procedures and their role in preventing mix-ups and cross-contamination.
Experience conducting audit trail reviews for manufacturing equipment and computerized systems.
Understanding of Data Integrity principles (ALCOA+) and their implementation in a GMP environment.
Experience participating in internal audits, customer audits, and regulatory inspections.
The position requires adherence to strict cleanroom protocols, including appropriate gowning and aseptic techniques, as well as compliance with environmental monitoring and facility procedures.
