Specialist 2/3, QA (Technical Compliance and Validation)

Specialist 2/3, QA (Technical Compliance and Validation)

Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.

As a Senior QA Specialist, you will support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a multi-product, GMP contract manufacturing facility.

Key Responsibilities:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a multi-product, GxP contract manufacturing facility.
• In-depth awareness of the entire process, identifying operational factors which influence the process.
• Lead a small team and provide supervision to QA Coordinators, interns, or QA Specialists.
• A competent Reviewer and Approver of SOPs, protocols, reports, or records.
• Can troubleshoot and weigh all information to choose the optimum path to be taken.
• Demonstrate ability to lead a small project and manage the deliverables effectively.
• Develop good working relationships with internal & external customers.
• Able to participate actively or lead in deviation investigations, change controls, CAPA plans, and closure of discrepancy reports.
• Develop skills as an internal GxP auditor, as required.
• Provide support in regulatory inspections and customer audits as required.
• Plan for future activities and coordinate with other departments to complete this.
• Develop skills to be a Qualified Trainer in the area of expertise.
• Any other tasks as assigned by supervisor.

Key Requirements:

• Degree in Biological Science/Engineering and experience in Validation/Quality unit in the Biopharmaceutical industry.
• 3-5 years of experience in a similar type of industry or a similar job role.
• Able to operate independently with minimum supervision.
• Fair knowledge and experience of the practical and theoretical requirements of quality management systems in a GMP facility.
• Team player, with a strong focus on safety, quality, and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege but also a great responsibility. At Lonza, we respect and protect our people and our environment.

Reference: R63010