Sr. Quality Assurance Associate, Vendor Management

Job Type

Full-time

Description

Job Summary

The Sr. Quality Assurance Associate, Compliance & Vendor Management position ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for the vendor qualification program in accordance with cGMP and related company SOP's, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations ICH guidelines on how to run a vendor management program. The persons are fully responsible for the execution and oversight of the vendor management program for all vendors and service providers of Granules Pharmaceuticals.

Principle Accountabilities

JOB DESCRIPTION & RESPONSIBILITIES

• Author and review standard operating procedures.
• Completion and organization of vendor qualification documentation
• Ability to redesign the vendor management program.
• Knowledge and the ability to perform audits of but not limited to contract testing labs, contract packagers, contract manufacturers, and raw material vendors when needed.
• Knowledge in the serialization of pharmaceutical products.
• Any other activity as assigned by the Supervisor
• Ability to write change controls for changes made to processes or vendors.
• Ability to write investigations using root cause analysis tools.
• Ability to write quality agreements.
• Any other activities as requested by management.

Reports to

Quality Assurance, Director

Internal / External Contacts

N / A

Requirements

Knowledge & Skills

Minimum Experience & Education

Physical Requirements / Working Environment

Travel Up to 25 % travel may be necessary.

Disclaimer The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.