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 a Head Qualified Person (QP) be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
Perform the duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC. Will be accountable for reviews of relevant documentation associated with the manufacture and testing of Drug Substance and Drug Product Intermediates.
Responsible for ensuring that the QP Team supports the site in the timely disposition of GMP batches. Whilst being GMP Subject Matter Expert (SME) to facilitate site compliance with the companies Pharmaceutical Quality System (PQS).
QP Leadership Role – Principle Responsibility
- Lead and develop the QP team i.e. direct supervision of the QP team, 121, appraisals, IDPs
- Co-ordination and allocation of QP batch disposition activities
- Ensure adequate QP support on site as required i.e. regulatory inspections, annual leave, batch release and other site responsibilities
- Ensure that all QPs have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar.
QP Certification / Batch Release
- Ensure that continual professional development (CPD) is maintained to allow the QPs to effectively undertaken their statutory duties.
- Record items of CPD in line with requirements of the appropriate professional body.
- Ensure that all processes and procedures that are required for QP certification / batch release of drug substance are fit for purpose.
- Acting SME for queries relating to QP responsibilities, certification and batch disposition.
Operations QA Support
- QA support to initiate, manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs
- Provide QA/GMP SME expertise to assist non-QA functions with progressing major and critical compliance issues through the QMS processes.
- QA/GMP SME expertise and mentoring to other QA(Operations) team members
- Represent QA (Operations) at Manufacturing and Quality Control LQC's and Team Times
- Utilising knowledge of GMP and quality processes to advise non-QA functions on compliance issues via interaction with the relevant personnel
- Apply cGMP regulations consistently. Expand compliance knowledge base and mentor others to expand on-site compliance knowledge.
- Utilising knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities within the QA (Operations) group
- Actively manage assigned areas of the QMS with full ownership for maintaining compliance status
- Act as an ambassador for Lonza and QA in all interactions with customers
- Proactively support customers’ needs and provide timely responses to queries and communications
- Act as a single point of contact in interactions between QA and internal Lonza functions and external customers and third parties as required .
More job information available on request
What we need you to have:
- BSc or MSC qualified within Biology, Chemistry, Pharmacy or any field recognized by the joint professional bodies.
- Extensive experience as a QP within a Biologics manufacturing environment.
- Hands on experience supporting senior QA leadership and Operational leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’
- To identify and promote Lonza Slough talent who may be trained in house as QPs... ensuring a “steady” stream of QP supply for the business
- Actively develop, mentor, train and enforce a site GMP culture within Operations.
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.