Senior Quality Systems Specialist

Our pharmaceutical client is seeking a Senior Quality Systems Specialist who will be in charge of ensuring compliance with quality standards and regulatory requirements.

You will help with designing, modifying, implementing, and maintaining QMS, including documentation and the auditing processes.

Requirements:

Minimum of five (5) years of experience in the pharmaceutical industry.

Writing and/or reviewing QMS documents (deviations, change controls, CAPAs, other quality events etc.)

Identifying deficiencies and proposing overall compliance improvements

Initiates, investigates, and documents deviations and other quality events.

Performs root cause analysis.

Develops, in conjunction with area management, effective corrections, corrective actions, and preventive actions.

Initiates, investigates, and closes customer complaints.

Ensures customer complaint data is tracked for trend review, annual product review and management reviews.

Assists with the Vendor Management Program including Quality Agreements

Completes Annual Product Reviews (APRs)

Writes and reviews documentation (quality events, standard operating procedures, work instructions, stability protocols, change controls, etc.).