The candidate for the Manufacturing Quality Assurance Specialist has a robust understanding of applicable regulations and standards and is able to apply company policies, directives, and procedures to ensure compliance by conducting review and approval of quality and production related documentation and procedures in support of internal manufacturing operations. The position advises QA management of compliance issues, conducts quality related activities of diverse scope, and makes decisions and implements associated actions in partnership with the broader team.
Act as a quality resource and liaison to operations/manufacturing partners.
Oversee activities related to cGMP production operations.
Assist in the development of Standard Operating Procedures, Master batch Record in order to maintain quality systems in line with current regulations, company directives, and industry standards.
Write and revise Quality Procedures related to production activities.
Review manufacturing balch records and logbooks.
Monitor and inspect the production facility during product manufacture and notify QA and manufacturing of potential quality issues.
Participate in corporate audits and self audits and monitor implementation of CAPAs.
Carry out assessment of the event, and manage investigation of Deviation, Incident and complaint.
Participate in training activities to production personnel.
Monitor the proper implementation of change control for production activities.
Assist in preparation of quality reports, such as APR, and with routine quality KPI reports
Bachelor's Degree in scientific or technical discipline
Three (3) + years' experience in Quality Assurance operations or systems role, e.g., quality systems (deviation/CAPA, change control), batch record review, auditing
Four (4) +years Pharmaceutical/ Regulated Industry experience
Good organizational skills with high level of attention to detail
Excellent oral and written communication skills with the ability to interact at all levels both internally and externally