Jobs

Description

This is essentially a Packaging Compliance + Documentation + Training Lead role in a pharmaceutical manufacturing environment

Duties: 

• The Principal Specialist, Packaging Training & Compliance will lead the Packaging (PKG) documentation team in order to support the production line as required through batch documentation review, deviations, change controls, CAPAs, and document creation / revision in compliance with procedures and regulatory requirements.
• Develops, reviews, and maintains an up-to-date training program to meet all compliance requirements and packaging requirements.
• Maintains supplemental training records and ensures all personnel are up to date on all compliance requirements.
• Primary means of tracking training will be through LOS System.
• On the Job Training (OJT) will tracked separately outside of LOS. Implements effective CAPAs to mitigate potential issues in deviations and audits.

Product Release:

• Oversee the review / approval of manufacturing records, deviations, product holds / dispositions, change controls, CAPAs, document creation / revision, etc. as needed to release product according to applicable procedures.
• Act as PKG internal SME for routine production issues leading towards deviations, product dispositions, and response corrections needed to continue production.
• Supervisor areas: Lead PKG document specialist through daily operations. Conduct or assist with performance evaluations and development discussions.

Skills:    

• Performs all Company business in accordance with all regulations and Company policies and procedures.
• When violations are noted/observed they are to be immediately reported to management.
• Demonstrated high ethical and professional standards with all business contacts in order to maintain client excellent reputation in the community

Education:         

• Bachelor’s degree, from an accredited institution