Senior Quality Control Engineer

Katalyst CRO; Frankfurt; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Katalyst CRO in Frankfurt is seeking a senior QA/QC systems lead to drive the implementation and integration of GMP QC systems. You will coordinate configurations, data migration, and stakeholder engagement to ensure timely go-lives.

The role requires extensive CQ/Lab systems validation experience, IQ/OQ/PQ execution, and strong knowledge of CSV, CSA, and GxP regulations, with proactive risk assessment and cross-functional collaboration.

Qualifikationen

• 8+ years in pharmaceutical, biotech, or GMP environments.
• Strong experience with QC/Laboratory systems implementation and validation.
• Knowledge of CSV, CSA, GAMP5, and GxP regulations.
• Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
• Experience managing system integrations, data migration, and cross-functional project delivery.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.
• Strong stakeholder management, Agile/Scrum, and project coordination skills.
• Excellent communication and documentation capabilities.

Aufgaben

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation.
• Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.

Kenntnisse

QC/Lab systems implementation

CSV/CSA validation

IQ/OQ/PQ execution

GAMP5 familiarity

GxP regulations

Risk assessments

Testing

Stakeholder management

Agile/Scrum

Project coordination

Data migration

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Jobbeschreibung

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.

Roles & Responsibilities

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.

Requirements:

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
• Experience managing system integrations, data migration, and cross-functional project delivery.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities