Quality Associate – GMP & DI Compliance Job at Haryana, India Full Time

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. 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. And that’s the kind of work we want to be part of.

Job Description Summary

• Site Quality and GMP Compliance
• Site Data Integrity Management
• Quality and DI Culture Initiation
• Training and GEMBA Walk
• Regulatory and Statutory / Religious Compliance – Licenses / Certification.
• Compliance to USDMF, China DMF, State FDA, FSSAI, TGA and other related regulators.
• Risk Register and Risk Assessment
• Customer Expectation

Key Responsibilities

• Acting as a subject matter expert for Data Integrity and GMP compliance.
• Acts as change manager to increase quality oversight on the shop floor. Facilitates and supports co-location of QA/Operation to increase right-first-time.
• Actively contributing to the Quality Vision outlined by the Senior Management Team of reducing the gap between actual practices versus defined SOP / Procedure.
• Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and Lonza procedures, as appropriate.
• Liases with all necessary functions during investigation, e.g. QA , Operations, QC, M&E, or external suppliers. Acts as change manager to increase quality oversight on the shop floor.
• Play an active part in the development of the Quality System (QS) by constructively challenging deficiencies and inefficiencies.
• Conduct GEMBA walk as per the approved schedule to detect process and procedural deficiencies. Support the affected areas to ensure appropriate corrective and preventive actions (CAPAs) are undertaken to correct any observations.
• Suspect Analytical Results, Risk Assessments, Technical Agreements, Procedures, Generation, approval and training of new/revised procedures etc.
• Communicate with internal and external stakeholders regarding projects, products, complaints and other quality related topics, building relationships and trust.
• Monitor and contribute to GMP & DI compliance and Quality of manufactured finished product.
• Conduct annual GMP / GDP training to respective GMP Areas as and when scheduled.
• Provides support for internal and health authority inspections and requests.
• Lead teams to provide scientific evaluation of issues to mitigate business and compliance risk as well as maintaining product quality and product supply of finished products
• Strictly follow procedures laid down in the quality manual & SOP’s and STP’s.
• Meeting Statutory / mandatory requirement of the customer and local FDA.

Key Requirements

• Degree in B.Pharma/M.Pharma/MSc
• Work experience of 4 to 8 years in similar field.
• Good Communication skills.
• Experience in Quality Assurance Function.

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. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.