Johnson & Johnson Careers
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Requisition ID: 1805635174W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
The QE is responsible for the GMP/GDP quality of the products that the company markets and ensuring that the company meets all the requirements of GMP/GDP.
The QE is responsible for compliance with the J&J Quality Policy and Quality Management System, as applicable to the activities that the company undertakes and particularly in the area of GMP/GDP.
Key responsibilities of the role:
To include but not restricted to:
- Prepare, update and approve procedures in accordance with GMP/GDP and J&J requirements. Manage all documents in accordance with records management requirements.
- Provide annual GMP/GDP, deviations and complaints training to appropriate business functions.
- Manage the Control of Change process and ensure the process is followed.
- Assist with the preparation, execution and follow up of external inspections.
- Assist with metrics and Management Review as appropriate.
- Perform allocated internal audits.
To include but not restricted to:
- Perform the process for handling Customer Complaints, with particular responsibility for serious or high complexity complaints:
- Assess customer complaint record and verify classification, review and sign complaint letter
- Review complaint investigation and close customer complaint records/Perform closure issue review
- Identify those complaints that need immediate action and refer these complaints to BQ Manager. Follow escalation process where required.
- Prepare internal management reports providing complaints statistics and highlighting trends/serious defects as required.
- Draft appropriate responses to Health Authorities when requested regarding the product quality complaints and respond where delegated by the BQ Manager.
- drive continuous improvement in local complaints management process
- Identify and log quality issues, perform impact assessments, lead and approve investigations and follow up of all internal quality issues and CAPAs related to GMP/GDP. Also manage and follow up on third party quality issues that could impact Janssen’s QMS.
- Perform Product Quality Reviews, including local PQRs reviews.
- Ensure that all required site licences are available and kept up to date as required by local regulations.
- Perform the QA approval of repackaging jobs and ensure that all required aspects of GMP are followed at both the repackaging site and within the company for these jobs.
- Ensure that all external contractors/suppliers relevant to GMP/GDP are appropriately managed and approved and that up to date technical agreements are in place. Perform supplier audits as required.
- Ensure that a robust quality system is in place throughout the supply chain, at third party warehouse and within the company, to ensure compliance with GDP and any requirements of the Wholesale Dealers Licence.
- Assist in escalations to management and lead where delegated by the BQ Manager.
- Perform batch management activities such as release, reject, quarantine on SAP.
- Support training for new members of the quality team, where required.
- Work closely with the sites and CLS to ensure that Temperature Control requirements are fulfilled during storage and transportation activities.
The QE should meet the following knowledge, experience and skills:
- primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
- previous experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution, Warehouse management. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential;
- understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
- up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
- strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
- knowledge and full understanding of the J&J Quality Policy and Standards, the Cluster / LOC QMS and CLS QMS
- Business acumen to balance safety, compliance and availability of product for a patient
- Team player within region, ability to leverage across LOC’s in EMEA / WW
- Open for standardization: regional and local thinking, team player at EMEA level
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)