AddressToday, 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.
Key Responsibilities:
Responsible for QMS management for Change Control / Deviation / Investigation / CAPA / OOS / OOT, APQR etc.
Preparation, review & approval of SOP’s, Site Mater file, VMP etc.
Response preparation for the External audit (Customer or Regulatory or third parties.). Preparation, scheduling & conducting self – inspection audits.
Responsible for handling Market Complaints & conducts Investigations for timely response to customer.
To ensure annual product review is completed as per the timeline and review the control samples of finished product and report prepared.
Review and Issuance of WOP to Production, Insurance of control documents to other departments.
Quality Parameter checks for Retain samples/ APQR samples and documentation.
Key Requirements:
M.Sc / B. Pharma with minimum 8 to 10 years of relevant experience in Quality department in Pharma Industry (Formulation plant).
Well verse with GMP, GDP, Change control, deviation, QMS.
This is individual contributor role.
Able to work in rotational shift working hours.
Preference given if have experience in handling Regulatory Audits like MHRA, USFDA, Local Audits.
Good in Communication.
This position is based in Dharuhera - Haryana site.
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.
