Contract QA Specialist,

Contract QA Specialist, Validation / Qualification

The Contract QA Specialist, Validation / Qualification is responsible to provide quality oversight and ensure that validation and qualification activities conducted at Lupin Somerset are in compliance with FDA regulations, guidance and other recognized industry standards. This is a contract role for Monday-Friday work week.

Responsibilities and Duties:

• Provide quality oversight for validation and qualification of facilities and utilities, equipment, manufacturing, packaging and cleaning processes and computer systems.
• Implement policies and procedures for validation and qualification systems consistent with FDA regulations, corporate and site requirements.
• Review and approve all protocols, plans, risk assessments and reports pertaining to validation and qualification of the above systems.
• Review and approve applicable change controls including an impact assessment regarding changes to validated systems and processes.
• Ensure that the knowledge acquired during validation / qualification is incorporated into batch records, SOPs to ensure the validated state of the processes is maintained throughout lifecycle.
• Collaborate with SMEs from various functional departments to ensure that validation and qualification activities are consistent with requirements of site / corporate SOPs.
• Other duties as assigned by leadership.

Minimum Education and Experience Requirements:

• Minimum bachelor degree in a scientific or technical field; graduate degree desired.
• 3+ years' of extensive experience in the pharmaceutical industry in quality assurance. Cross functional experience in engineering, technical operations or product development is a plus.
• Working knowledge of FDA and applicable non-US regulations, guidance and industry standards pertaining to pharmaceutical drug manufacturing.
• Experience with process / method validation or equipment / facility qualification is a big plus.
• Experience in using electronic quality management system, ERP system, MS Office applications.
• Excellent analytical, coordination and influential skills; must be able to persuade cross functional.