Quality Manager

Kaztronix was founded in 2002 with a vision to impact the staffing industry by making the finest talent and consulting solutions easily accessible to organizations spanning numerous industries. Simply put, we source and qualify the best industry talent available, providing flexible solutions to meet the business objectives of our clients.

Responsible for preparation and review of the Annual Product Review Reports for Client marketed products and select third party products per contractual agreements and in accordance with company and government regulations.

• Responsible for the preparation of the Annual Product Review Reports according to the established schedule.
• Responsible for the compilation and data interpretation of analytical, manufacturing and regulatory data.
• Responsible to draw conclusions from real-time data and statistical reports.
• Responsible to ensure that established testing control procedures are followed.
• Responsible for serving on various project teams to fulfill activities as assigned.
• Responsible for writing and updating applicable SOP's
• Responsible for maintaining APQR schedule.
• Responsible for the Annual Product Review Report record keeping.
• Responsible for the scheduling meetings with the APR team to determine the follow-up action items.

Skills:

• Minimum 5 years in the pharmaceutical industry with an emphasis on Quality Assurance.
• Demonstrating cGMP knowledge. Applicable PC software knowledge and prior experience with DRAGON, T EDI. SAP. LIMS (Laboratory l information Management). Knowledge of cGMPs. ( ICH Guidelines).
• Possess the ability to manage multiple projects and work independently in ambiguous situations.
• Excellent technical writing skills and the ability to manage data is required. Strong analytical background.

Education:

• A Bachelor/Master of Science degree in a science, analytical field, and pharmaceutical industry.