QA Batch Review Associate
United Kingdom, Slough
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
We are currently looking for an experienced Quality Associate- Batch Review be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
To ensure that Quality is maintained at an appropriate level meeting, customer and regulatory expectations and to enable the Lonza Slough Site to deliver to relevant targets. This will be achieved by assessing compliance to site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliances through the PQS, site governance mechanisms and senior QA leadership.
- Auditing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up actions/corrections of GMP documentation assays/raw data and validation reports.
- Reviewing batch records generated by Manufacturing.
- Acting as a point of contact for general queries relating to Quality and escalating as required.
- Expand and utilise knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel
- Raw Material release.
- Vials auditing and releasing and Cell Banking documentation auditing.
- Ensure current GMP requirements for all area are met.
- Assist in preparation of area for inspection readiness.
- Advising operators on best practises for document completion review and follow up actions/ escalate if required.
- Identify discrepancies and deviations and to distinguish appropriate classification and appropriate follow-up actions in areas where trained.
- Developing ability to interpret and apply GMP regulations consistently.
- Assisting with the mentoring and training of other departments in QA skills and knowledge.
- DMS document editor for document errors identified in QA.
- Performs basic document reviews of SOP’s, batch records, test methods, and logbooks
What we need you to have:
- Degree (or equivalent) in a science
- Hands on work experience in QA / GMP experience is essential.
- Experience in management and approval of GMP documentation is desirable
- Coaching and mentoring more junior team members.
- IT literate - MS Office – Word, Explorer, Excel, Access, Outlook.
- Database familiarity with data entry/searches / queries.
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