Johnson & Johnson Careers
Requisition ID: 1805676605W
The primary objective of this position is the overall responsibility of the pharmacy at the Clinical Pharmacology Unit (CPU Pharmacy), which includes the accurate and efficient dispensing of clinical study medication according to the study protocol, drug accountability and adequate storage of medication.
The Pharmacist should also support the expansion of the capabilities of the Janssen Clinical Pharmacology Unit relating to the clinical drug development programs of the Johnson & Johnson group of companies. This should be done in compliance with ICH-Good Manufacturing Practice (GMP), Good Dispensing Practice (GDP) and Good Clinical Practice (GCP) guidelines, the WHO Declaration of Helsinki, and other relevant laws and regulations. The Pharmacist will collaborate with the Director Quality Assurance (QA) - Qualified Person (QP) Janssen Supply Chain (JSC).
Main Accountabilities CPU Pharmacy
- Is responsible for the conduct of all pharmaceutical activities (reconstitution, dispensing, manufacturing, accountability and storage) in the pharmacy at the CPU in compliance with international and local GMP/GDP regulations;
- Reviews and provides input to the trial protocol and Informed Consent Form (ICF), with a focus on the clinical study medication and associated dispensing and/or manufacturing related procedures, and addresses potential risks related to the use of the study medication;
- Partners with the responsible investigator and trial coordinator to establish the pharmacy’s role and planning for preparation and dispensing of study medication;
- Provides drug information related to clinical study medication such as storage conditions, drug handling and administration instructions and drug return instructions, to physicians, nurses and other study team members;
- Maintains accurate records on pharmaceutical activities including drug dispensing and drug accountability forms;
- Supervises and monitors all pharmacy activities, to ensure adherence to study protocols, dispensing and/or manufacturing procedures and relevant guidelines and regulations;
- Is responsible for the release of dispensed and/or reconstituted IMP. For GMP related activities the review and decision processes should be done with approval of the Director QA - QP JSC.
- Ensures that the Review and Decision processes are always done in consultation with the Director QA – QP JSC.
- Ensures and maintains a robust quality system that describes the reception, storage and distribution process and its applicable controls, and which must guarantee the right product quality and identity throughout the supply chain processes with respect to Good Distribution Practices;
- Approves GMP/GDP documents that are linked to the distribution process;
- Discusses and decides upon final disposition of returned, rejected and recalled products if needed in collaboration with the Director QA – QP JSC.
- Supports the preparation, execution and follow-up of inspections and audits and act as the Pharmacy spokesperson;
- Ensures and supports the drafting and execution of the Corrective And Preventive Action (CAPA) plans;
- Creates, sustains and manages a pool of qualified pharmacists and Pharmaceutical Technicians;
- Monitors that GMP/GDP rules and regulations are clearly implemented for all employees at the CPU involved in pharmaceutical activities;
- Is the subject-matter expert, responsible for compliance with the internal quality system. Provides direction and actively contributes to developing, improving and implementing Standard Operating Procedures and Working Instructions. Notifies any violation or deviation to the immediate supervisor or appropriate authority.
Other Accountabilities and Duties
- Is a member of the CPU Operational team;
- Acts as the deputy for the Head pharmacy and Operations for IMP supply chain related topics;
- Acts as the register holder for narcotics;
- Participates in validation and implementation of new systems, guidelines and methods;
- Credo: liaises with all the members of the Department and makes a positive contribution towards team spirit in collaboration with the Credo Team.
- Observes and promotes all regulatory requirements as defined per the applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority;
- Complies with all training requirements necessary to perform the duties of the job;
- Ensures that assigned (on-call) staff complies with the training requirements necessary for specific tasks.
Responsibility for Others
- Leads and coaches on-call staff of the CPU Pharmacy;
- Trains and coaches new employees
Minimal Educational Background and Qualifications
- Pharmacist (a Master’s degree in pharmacy, Master of Industrial Pharmacy (Manama), hospital pharmacy and/or Doctor of Pharmacy (PharmD))
- Appropriate competence and experience as well as knowledge of and training in GMP and GDP
- Qualification to act as a Qualified Person is a plus
Minimal Work Experience
- Previous responsibility for groups or department is an advantage
- Phase 1 drug development and/or CRO industry experience is an advantage
- Project management experience is an advantage
- Exposure to Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG), European Medicines Agency (EMA), and/or Food and Drug Administration (FDA) inspections is an advantage
Minimal Technical Skills, Knowledge and Qualifications
- Good working knowledge of ICH-GCP guidelines, EU Clinical Trial Directive , GMP regulations (Annex 13, etc.), GDP regulations and other relevant regulatory guidelines and regulations
- Able to apply technical/professional knowledge to the execution of the clinical trials with focus on dispensing and manufacturing of study medication
- Fluency in written and spoken English
- Proficiency in written and spoken Dutch
- Computer literate
Minimal Non-Technical Competencies and Skills
- Supervisory skills
- Able to coach and able to manage people of widely varying educational backgrounds
- Strong organizational, operational and management skills
- Strong written, verbal and interpersonal communication skills
- Able to prioritize and multi-task
- Able to establish and maintain effective working relationships
- Good accuracy, structural approach and attention to detail
- Pro-active and creative in identifying and solving problems
- Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
- Able to cope with administrative tasks
Minimal Other Requirements
Willingness and ability to be flexible with work hours and when necessary to work outside office hours to liaise with teams based in other time zones and to travel for business development, scientific and management purposes.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)