Senior Validation Lead: Pharma Packaging & Automation

Kelly Science, Engineering, Technology & Telecom; Södertälje kommun; Sur place; SEK 900 000 - 1 200 000; Plein temps

Résumé du poste

Kelly Science, Engineering, Technology & Telecom seeks a Senior Validation Lead for pharmaceutical manufacturing in Sweden. You will own qualification and validation activities across packaging lines, equipment and systems, ensuring GMP compliance and adherence to GAMP 5 and internal quality standards.

The role involves coordinating cross-functional teams with Production, Engineering, Quality and Automation to translate regulatory requirements into practical manufacturing solutions and

Qualifications

• Experience leading qualification and validation of pharmaceutical packaging and manufacturing processes.
• Strong knowledge of GMP requirements and regulatory expectations.
• Ability to translate regulatory and quality requirements into practical manufacturing solutions.

Responsabilités

• Lead qualification and validation activities for pharmaceutical packaging lines, equipment and related systems.
• Own validation across technical changes, investment projects, equipment modifications and lifecycle initiatives.
• Ensure qualification and validation activities comply with GMP, GAMP 5, internal standards and applicable regulations.
• Prepare, review and approve URS, IQ/OQ/PQ documentation, validation plans and reports.
• Coordinate cross-functional validation teams and external suppliers.

Connaissances

Qualification & validation

GMP compliance

GAMP 5

Cross-functional collaboration

Description du poste

Kelly Science, Engineering, Technology & Telecom seeks a Senior Validation Lead for pharmaceutical manufacturing in Sweden. You will own qualification and validation activities across packaging lines, equipment and systems, ensuring GMP compliance and adherence to GAMP 5 and internal quality standards.

The role involves coordinating cross-functional teams with Production, Engineering, Quality and Automation to translate regulatory requirements into practical manufacturing solutions and