Description

Responsibilities include, but are not limited to the following:

• Performing line clearances on a timely basis.
• Monitoring of packaging/inspection operations for conformance to specifications and SOPs.
• Maintaining and monitoring of logs –recording required information neatly and accurately.
• Preparing written reports, recording all information accurately and at required intervals.
• Maintaining of house standards, comparison of products for physical aspects/appearance.
• Providing editorial support and proofreading of labeling components (new and revised) to ensure product labeling requirements.
• Preparing and revising SOPs, BPRs, and labels for drug products.
• Assisting in technical guidance for compliance with cGMP, for completion and approval of complaints and investigational reports.
• Responsible for conducting cGMP training and other job-specific training and maintaining logbooks.
• Issuing of Batch Production Records and reviewing the daily production data.
• Preparing and reviewing of validation protocol.
• Receiving, Inspecting/Sampling, and releasing bulk products and packaging components.
• Responsible for cleaning validation of packaging lines.

Requirements

Skills and Abilities:

• Excellent organization skills and detail-oriented.
• Ability to manage multiple tasks and meet company deadlines.
• Proficient in Microsoft Word, Excel, PowerPoint; Microsoft Office Outlook.
• Must be able to follow exact instructions set by the FDA.
• Must be able to communicate efficiently and effectively.
• May be required to work at the last minute.

Education Qualification and Experience Requirements:

• Qualification: Bachelor’s in Science/MS
• Experience: Minimum 1 -2 Yrs. Industrial Experience in the related field
• Previous experience and knowledge of Quality Assurance and Regulatory Affairs are required.
• Previous experience in packaging in the pharmaceutical industry is a major plus.