Quality Assurance Packaging Support Specialist

Description:

QA Packaging Support Specialist:
The QA Packaging Support Specialist, reporting to the QA Packaging Manager, responsible for ensuring that all activities related to the investigation and resolution of non-conformities are performed in a timely manner and in compliance with company and regulatory requirements
Strong knowledge and understanding of regulations and guidelines in packaging processes and QA inspection activities in packaging
Strong knowledge and understanding of Data Integrity requirements
Strong Technical writing skills, problem-solving, and analytical thinking are essential to the role.

RESPONSIBILITIES:

To provide a daily report on QA performance information as required to communicate quality metrics information where applicable attend packaging tier meetings and provide information on investigations progress as assigned by the QA Packaging ManagerEnsure regular Quality interaction with other Departments

Main Activities:

Proficiently lead and participate directly in the investigation of Deviations/Non-Conformances/Technical Complaints to ensure investigations are completed in a timely manner and high-quality standards effectively and efficiently write Deviations/Non-Conformances investigation reports

Responsible for reviews and evaluations for completeness and compliance of the investigation reports and CAPA plans authored by Subject Matter Experts (SMEs) and other company personnel responsible for delivering training related to CAPA, Root cause analysis and quality investigations to company employees efficiently follow up and verifies that corrective/preventive actions are appropriate, are implemented as planned and have the intended effect in the QA Packaging DepartmentParticipate/Lead investigations due to quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.

To participate/lead Quality risk assessment Responsible for developing SOP’s as neededResponsible for periodic reviews and updates of QA Packaging SOPs Participate and action change controls tasks assigned to the QA Packaging DepartmentResponsible for participating in the internal audit program lead Process/product/system improvement projects in the QA PackagingTraining of new QA Packaging personnelGMP implementation and site-wide Quality Awareness related to the Packaging process.
Participate in various inspections e.g. HPRA, FDA, customers, etc. Liaise with other Department representatives to promote improvements in GMP and Quality standards any additional tasks as assigned by the QA Packaging Manager