מדעים/ביוטק

QA Specialist

622480

תאריך עדכון

15/12/2021

תיאור המשרה

· 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

Requirements

· 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.

· Excellent communication skill and teamwork.

· Previous experience in writing and reviewing quality professional documents.

· Experience in Auditing techniques- advantage

· High level written and verbal English. 

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