Senior Manager QC Chemistry - Limerick
Collins Mcnicholas Recruitment
Limerick
Oversees the laboratory Quality Control testing of in-process, stability and final drug products. Has technical responsibility for all chemical aspects of QC testing. Responsibilities: Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support. Manages QC Analysts, distributes work load, and monitors progress. Oversees product testing to ensure efficient and compliant operations. Reviews test reports. Ensures QC Analysts receive proper training. Attends meetings to keep informed of manufacturing priorities. Ensures that safety standards are maintained. Ensures compliance with applicable cGMP regulations and SOPs. Investigates atypical and OOS test results as necessary. Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory. Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed. Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness. Track and coordinate major analytical investigation. Track and monitor timeline of analytical validation projects. Monitor the team performance for Compliance events, track, assist and organize continuous improvement event. Interact with Regulatory Agencies as needed to ensure cGMP compliance. Special projects as assigned. Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations. Skills, Education and Experience: BS in chemistry, biology or related field with 8+ years’ relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years’ experience in a supervisory/leadership capacity. Thorough understanding of Analytical Testing in a cGMP environment for Raw Materials, Wet Chemistry, and HPLC assays. For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.
2227 days ago