Senior Life Science Validation & Quality Lead

Alfa Laval Mid Europe GmbH

Stockholms kommun

On-site

SEK 900,000 - 1,200,000

Full time

8 days ago

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Job summary

Alfa Laval is seeking a LifeScience Quality & Validation Lead to ensure quality, compliance and performance of Life Science systems throughout the product lifecycle. You will develop validation documentation, lead audits, and drive risk-based validation strategies across development and maintenance projects.

You will collaborate with R&D and Quality to align with GMP standards, participate in testing at facilities and with subcontractors, and mentor teams in best practices and regulatory

Qualifications

Minimum five years' experience validating complex Life Science/pharma systems.
Strong GMP/pharma compliance knowledge.
Familiarity with computerized system validation (CSV).
Experience with risk-based validation approaches.
Experience with FAT, IQ, OQ activities.
Excellent English communication.

Responsibilities

Create and maintain validation documentation, SOPs, test protocols and qualification protocols (CSV, FAT, IQ, OQ).
Manage validation-related change control across development and maintenance projects.
Define requirements for software, components, validation and testing with R&D, Quality and stakeholders.
Lead internal, external and customer audits, identifying deviations and actions.
Lead risk assessments and define Validation strategies across the product lifecycle.

Skills

Validation

Quality Assurance

GMP Compliance

CSV

Risk Assessment

Audits

Communication

Job description

You will collaborate with R&D and Quality to align with GMP standards, participate in testing at facilities and with subcontractors, and mentor teams in best practices and regulatory

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