The QA III primary responsibilities will be executing and supporting QA operation functions including assessing, evaluating, and reviewing operations on the floor against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation.
Duties:
Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
Identifies, classifies and reports deviations, as appropriate.
Ensures support for the timely closure of investigations.
Oversees execution of remediation/CAPA activities required to continue production or move a process along.
Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities as well as logging and filing of documentation.
Qualifications:
Bachelors degree in Life Sciences or other applicable field preferred.
Three (3) to five (5) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.
Knowledge of relevant regulatory guidance’s. Demonstrated problem-detection and problem-resolution skills required.
Strong Interpersonal skills.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
732-661-0400
info@astrixinc.com