Senior Specialist 1, QA (Lot Review)

Senior Specialist 1, QA (Lot Review)

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.

The QA Specialist will be responsible for performing day-to-day tasks of the QA Department in a GMP facility manufacturing clinical and commercial pharmaceutical products.

Key responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility.
• Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures.
• Compile lot genealogy.
• Participate actively and approve deviation investigations, utilizing Root Cause tools to enable effective and timely closure of deviation investigations.
• Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
• Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies.
• Support changeover activities and QA on Call.
• Provide training to new members and participate in walkdown/ QA on Shopfloor and provide feedback to members of cross-functional site team(s) on projects / issues.
• Participate in Regulatory Inspections or Customer Audits as required.
• Assume Supervisory responsibility in absence of supervisor.
• Any other tasks as and when assigned by supervisor.

Key requirements:

• Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
• Relevant QA Operations background from the Biopharma environment.
• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, ICH Q7).
• Meticulous and systematic.
• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.