1.Maintenance and implementation of the Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.) as are described in the Commercial Quality Manual (CQM);

2.Drive continuous improvement of the Quality System & processes using quality system performance information, in conjunction with information from periodic internal audits, deviation management, CAPA management etc;

3.Drives temporary / short term workforces as are assigned by the Quality Head;

4.Ensure that J&J Innovative Medicine marketed products, packaging components, labelling meet the local regulatory requirements;

5.Support implementation of the regulatory standards management standard and procedures;

6.Prepare, update applicable LOC procedures;

7.Responsible for assigned product change controls and ensure appropriate internal and external change control procedures are followed;

8.Preparation, execution and follow up for external inspections for responsible areas;

9.Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in Commercial Quality Manual (CQM);

10.Conduct assigned (self-)inspections of GxP practices that are applicable for all regulated functions under J&J Innovative Medicine;

11.Ensure that all events and deviations for J&J Innovative Medicine products and critical systems are suitably, scientifically and logically handled, documented, investigated for route cause and assessed for its impact on product quality and safety;

12.Ensure appropriate corrective actions and preventive Actions (CAPA) are taken to mitigate the effect of an event / deviation as well as to prevent recurrence in the future.

1.Bachelor’s degree or higher in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;

2.>3 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Quality and Compliance (GxP), Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Quality and Compliance experience is essential;

3. Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;

4. Up-to-date knowledge of relevant pharmaceutical legislation and GxP. Full competency in local language and a working knowledge of English.