Job title – Quality
GCF - 26
Location – High Wycombe
About the role;
As a Quality Executive you are responsible for the GMP / GDP quality of, and meeting the applicable requirements for, the products and services of the cluster
In addition, you are responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that the cluster undertakes.
The role interacts internally within the business rather than externally with the customers, so a key element of this opportunity is the leadership and influencing behaviours needed. Achieving a balance between the technical skills and leadership communication is essential;
- You will ensure that a list of all relevant product sourcing, supply routes, product licences (marketing authorizations), product list, relevant authorizations and quality agreements is available and maintained up to date.
- Execute requirements regarding lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity. Including the preparation, update and approval of procedures assigned.
- Oversee the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the relevant systems.
- Ensure appropriate management of the preparation, execution and follow up of internal and external Quality Issues (QIs) and CAPAs related to GxP. Specific responsibility for Audits and Inspections and third party’s QIs and CAPAs. Act as a backup for Quality Head for approving audit reports on relevant systems.
- Monitor Quality System performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals.
- You will notify and engage the business with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures. The QE supports the local Quality Head for escalations of the LOC/Cluster where needed.
Experience and Skills:
The role requires someone with a strong and demonstrable background in pharmaceutical or Medical Devices, so if you have a Life science degree or pharmacy technician qualification or equivalent experience this would be looked on favourably
- Strong experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution and or Warehouse management.
- Fluent understanding and prior experience within Quality Systems (audits, supplier management etc)
- Someone who can strike the balance between technical competency and an ability to communicate to the wider business
- Understanding of pharmaceutical product development, qualification, manufacturing,
- Packaging, validation, testing, release and distribution processes;
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
What we’re about:
We are passionate about our work and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
- Committed to caring
- Responsible to our communities
- Ready to apply our knowledge and know-how
- Unique in our background and experiences
- The drivers of our own success
- Passionate about doing what’s right
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)