Senior Digital Quality Assurance Specialist

Regulatory Jobs

Wilmington (DE)

In loco

USD 120.000 - 165.000

Tempo pieno

5 giorni fa

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Descrizione del lavoro

Regulatory Jobs is seeking a Sr. Specialist Digital and Data Quality to oversee the quality aspects of GMP computerized systems across site facilities, utilities, manufacturing, packaging, labeling, and laboratories.

You will ensure data integrity and regulatory compliance throughout the system lifecycle, collaborating with IT, automation and engineering teams. The role requires hands-on experience in regulated pharma environments, strong knowledge of 21 CFR Part 11, and proven ability to drive

Competenze

Hands-on experience with automated systems in pharmaceutical manufacturing.
Experience delivering validated IT solutions or in a regulated environment.
Strong knowledge of FDA/EU/ICH regulations and 21 CFR Part 11, 210, 211, 820.

Mansioni

Provide independent quality approval of qualification/validation documentation.
Ensure systems remain in a validated status with SOPs and disaster recovery plans.
Support regulatory inspections and audit activities and respond to findings.
Drive resolution of regulatory non-conformance for GxP computerized systems.
Mentor junior team members and promote continuous improvement.
Collaborate with System Owners, Process Owners and Data Owners to assess legacy systems.