QA Specialist – Quality Control & R&D

רחובות |
3-4 שנים |
משרה מלאה
| 09/09/2021
תיאור משרה

: QA Specialist – Quality Control & R&D
• Review and approval of Laboratory work instructions and internal procedure.
• Review and approval of laboratory testing, in compliance with cGMP, the relevant regulatory guidelines / industry standards, and the relevant local and global safety guidelines.
• Review and approval of QC employees training and qualification records.
• Preparation and review of the relevant documentation for the QP release documents.
• Investigation OOS / OOT results and implementing robust corrective and preventive actions.
• Support the Implementation of Data Integrity requirement within the laboratory, including computerized system validation and Audit trail reviews.
• Review and approval of laboratory methods and validation (Bio-analytical and microbiology test method)
• Support the sterile manufacturing, environmental monitoring programs, data trending and OOS initiation.
• Support the continuous improvement of laboratory procedures, work instructions, forms, and risk assessments in line with all applicable standards, regulations, and site requirements
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Perform internal audits

דרישות התפקיד

• Bachelor’s degree in biology/Quality/Science.
• 3+ years of QA or QC or related quality control experience in the pharmaceutical industry.
• Experience with regulatory compliance in cGMP.