Manager, QA (Quality Assurance)

India, Haryana

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.

Key Responsibilities:

This position is based in Dharuhera, Haryana site & will be responsible to lead quality assurance function. The role plays a critical part in establishing the Quality assurance function, customer query response and full compliance and consistency with Lonza’s global quality standards .

  • Responsible for preparation of item  key for all new  orders from customers by using in house Platinum system

  • Provide support for all Audits (except Financial)

  • Responsible for periodic review of SOP’s of all departments

  • Support and participation in investigation of customer complaints

  • Responsible for plants rejection process, including proposed rework, disposal of rejected material

  • Take functional ownership of maintaining all documents pertaining to QA /QC department

  • Responsible for coordinate change control, deviation, OOS and other related QA activities and batch release.

  • Responsible for Quality training initiative (GMP) across the site.

  • The incumbent performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.

  • The incumbent normally receives little instruction on day-to-day work and receives general instructions on new assignments.

  • The incumbent establishes methods and procedures for attaining specific goals and objectives, and receives guidance in terms of broad goals. Only the final results of work are typically reviewed. The incumbent exercises wide latitude in determining objectives and approaches to critical assignments.

Key Requirements:

  • M.Sc / B. Pharma + Master Degree in Pharmacy additional advantage with minimum 12 years of relevant experience in Quality department in Phama Industry.

  • Hands on experience pharma plant set-up handling GMP & GDP, SOP’s, Change control, deviation, managing team of 6 to 10 people is must.

  • Able to work in rotational shift working hours.

  • Experience in handling Audits like USFDA, Local Audits.

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.

Reference: R45238