Qualified Person
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.
Lonza are currently looking for a fully certified Senior QP to work with the current site QP’s (Qualified Persons) to maintain and improve all activities directly and indirectly relating to QP certification and batch release.
You will be responsible for completion of all core GMP and relevant training and act as a point of contact for queries relating to QP certification and batch release. The ideal candidate will have a background in biologics, a proven track record as a certified QP together with a passion to make the world a healthier place and make a meaningful difference.
Key responsibilities:
- Provide QA support to initiate, manage and escalate major and critical compliance issues through the site PQS 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.
- Represent QA (Operations) at Manufacturing and Quality Control LQC's and Team Times.
- Actively suggest, initiate, participate and contribute to QMS process improvements initiatives and projects.
- Actively develop, mentor, train and enforce a site GMP Quality culture within Operations.
- Support regulatory and customer audits of the Operations areas and processes.
- Utilizing 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. Utilizing knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement.
- Actively manage assigned areas of the PQS with full ownership for maintaining compliance status. Support site QA leaders and other QPs with timely and reliable information to support site PQS management, decision processes and strategy development.
- Engage in self-inspection of the site PQS.
- Act as an ambassador for client and QA in all interactions with customers.
- Act as a single point of contact in interactions between QA and internal client functions and external customers and third parties as required.
Key Requirement:
- QP certificate (REQUIRED)
- Extensive hands on work experience as a QP on a manufacturing license.
- Experience in manufacturing of biological products.
- Excellent technical and scientific judgement.
- Ability to interpret and translate GMP guidelines into effective processes and procedures. Experience of MHRA, FDA and other regulatory inspections.
- Previous GXP and QMS process design, implementation, and management and utilization experience.
- Ability to work in team and solo capacity.
- Significant experience in risk management and project management.
- Strong auditing experience.
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.
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