GMP Method Validation QA Lead

Arrowhead Pharmaceuticals; Verona; In loco; EUR 81.000 - 107.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Excellent benefits

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a Quality Assurance professional to lead method verification/validation for analytical methods used in pre-clinical, clinical, and commercialization activities.

The role emphasizes mentoring QA members, ensuring data integrity, and supporting audits within a GMP environment. Requires a science degree and 8+ years of regulated manufacturing experience.

Competenze

• Bachelor’s degree in a science field.
• 8+ years of experience in cGMP-regulated manufacturing, specifically in method validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (ICH Q2, ICH Q7, 21CFR Part 210/211, EU Annex 11/15, and 21CFR Part 11).

Mansioni

• Serve as the Quality Assurance subject matter expert on method validation. This includes providing guidance, review, and/or approval of applicable validation strategy for analytical methods and supporting validation documentation.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Serve as a resource to mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, method validation, validation assessments, etc.).
• Work with cross-functional teams in the review and approval of internal and vendor-generated data/documentation in support of validation, qualification, and commissioning activities. Provide guidance on suitability of applicable equipment and assessment for use for validated method execution.
• Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs as related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes including establishment of CPV procedures for commercial manufacturing.

Conoscenze

Attention to detail

Communication skills

Multi-tasking

Formazione

Bachelor's degree in science

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a Quality Assurance professional to lead method verification/validation for analytical methods used in pre-clinical, clinical, and commercialization activities.

The role emphasizes mentoring QA members, ensuring data integrity, and supporting audits within a GMP environment. Requires a science degree and 8+ years of regulated manufacturing experience.