Job Details: Senior Quality Assurance Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Quality Assurance Specialist
JOB DESCRIPTION
THE IDEAL CANDIDATE MUST PROVIDE HIGH COMPLEXITY TACTICAL SUPPORT TO
SITE LEADS ACROSS MULTIPLE QUALITY SYSTEMS AND PROCESSES. KEY
RESPONSIBILITIES ? MANAGE AND OWN NC RECORDS FOR EXTERNAL QUALITY?
MANAGE AND OWN CAPA RECORDS FOR EXTERNAL QUALITY? MANAGE AND OWN
CHANGE CONTROL RECORDS INTERNAL TO EXTERNAL QUALITY? MANAGE AND
DRIVE QUALITY RECORDS TO CLOSURE INDEPENDENTLY? PERFORM TACTICAL
BATCH DISPOSITION ACTIVITIES IN SUPPORT OF LOT RELEASE? COLLABORATE
WITH COMPLAINTS TEAM TO REQUEST ASSESSMENTS, REVIEWS COMPLAINT REPORT
AND HAVE COMMENTS ADDRESSED? PROVIDE TACTICAL INFORMATION TO THE
NETWORKS (I.E., METRICS TO QMR, MR, DATA ANALYSIS, TRENDING, PERIODIC
MONITORING, APR)? ESCALATE RISKS OR ROADBLOCKS TO MANAGEMENT?
DRIVE TIMELY DECISION MAKING USING DAI PRINCIPLES? DRIVE CONTINUOUS
IMPROVEMENTS AND FIRST MINDSET? TRAIN ON REQUIRED QUALITY SYSTEMS
(NCMS, CCMS, LIMS, SAP, COMPLAINTS, AND OTHERS AS APPLICABLE)

REQUIREMENTS
BASIC QUALIFICATIONS: ? MIN BACHELOR?S DEGREE & 4 YEARS OF
DIRECTLY RELATED EXPERIENCE? CGMP EXPERIENCE? ABILITY TO OVERSEE
MULTIPLE PROJECTS SIMULTANEOUSLY? ABLE TO SUCCESSFULLY MANAGE
WORKLOAD TO TIMELINES? UNDERSTANDING OF THE APPLICABLE
MANUFACTURING/TESTING PROCESSES (I.E. API, DRUG SUBSTANCE, DRUG
PRODUCT, PACKAGING, DEVICE MANUFACTURING PROCESSES) PREFERRED
QUALIFICATIONS: ? 4+ YEARS OF QUALITY AND MANUFACTURING EXPERIENCE
IN BIOTECH OR PHARMACEUTICAL INDUSTRY (MED DEVICE WILL ALSO BE
CONSIDERED)? FAMILIARITY WITH BASIC PROJECT MANAGEMENT TOOLS?
ABILITY TO NEGOTIATE A POSITION AFTER TAKING FEEDBACK FROM MULTIPLE
SOURCES? DEMONSTRATED ABILITY TO CONSISTENTLY DELIVER ON-TIME, AND
HIGH-QUALITY RESULTS? ABILITY TO OPERATE IN A MATRIXED OR TEAM
ENVIRONMENTJOB DESCRIPTION
THE IDEAL CANDIDATE MUST PROVIDE HIGH COMPLEXITY TACTICAL SUPPORT TO
SITE LEADS ACROSS MULTIPLE QUALITY SYSTEMS AND PROCESSES. KEY
RESPONSIBILITIES ? MANAGE AND OWN NC RECORDS FOR EXTERNAL QUALITY?
MANAGE AND OWN CAPA RECORDS FOR EXTERNAL QUALITY? MANAGE AND OWN
CHANGE CONTROL RECORDS INTERNAL TO EXTERNAL QUALITY? MANAGE AND
DRIVE QUALITY RECORDS TO CLOSURE INDEPENDENTLY? PERFORM TACTICAL
BATCH DISPOSITION ACTIVITIES IN SUPPORT OF LOT RELEASE? COLLABORATE
WITH COMPLAINTS TEAM TO REQUEST ASSESSMENTS, REVIEWS COMPLAINT REPORT
AND HAVE COMMENTS ADDRESSED? PROVIDE TACTICAL INFORMATION TO THE
NETWORKS (I.E., METRICS TO QMR, MR, DATA ANALYSIS, TRENDING, PERIODIC
MONITORING, APR)? ESCALATE RISKS OR ROADBLOCKS TO MANAGEMENT?
DRIVE TIMELY DECISION MAKING USING DAI PRINCIPLES? DRIVE CONTINUOUS
IMPROVEMENTS AND FIRST MINDSET? TRAIN ON REQUIRED QUALITY SYSTEMS
(NCMS, CCMS, LIMS, SAP, COMPLAINTS, AND OTHERS AS APPLICABLE)

REQUIREMENTS
BASIC QUALIFICATIONS: ? MIN BACHELOR?S DEGREE & 4 YEARS OF
DIRECTLY RELATED EXPERIENCE? CGMP EXPERIENCE? ABILITY TO OVERSEE
MULTIPLE PROJECTS SIMULTANEOUSLY? ABLE TO SUCCESSFULLY MANAGE
WORKLOAD TO TIMELINES? UNDERSTANDING OF THE APPLICABLE
MANUFACTURING/TESTING PROCESSES (I.E. API, DRUG SUBSTANCE, DRUG
PRODUCT, PACKAGING, DEVICE MANUFACTURING PROCESSES) PREFERRED
QUALIFICATIONS: ? 4+ YEARS OF QUALITY AND MANUFACTURING EXPERIENCE
IN BIOTECH OR PHARMACEUTICAL INDUSTRY (MED DEVICE WILL ALSO BE
CONSIDERED)? FAMILIARITY WITH BASIC PROJECT MANAGEMENT TOOLS?
ABILITY TO NEGOTIATE A POSITION AFTER TAKING FEEDBACK FROM MULTIPLE
SOURCES? DEMONSTRATED ABILITY TO CONSISTENTLY DELIVER ON-TIME, AND
HIGH-QUALITY RESULTS? ABILITY TO OPERATE IN A MATRIXED OR TEAM
ENVIRONMENT

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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