Clinical packaging and labelling manager

Clinical packaging and labelling manager

Inceptua is a global pharmaceutical services company with market-leading capabilities across multiple business areas. We have over 25 years of experience serving life science companies of various sizes and global operations with offices across Europe, North America, and Asia.

We provide clinical trial supply, services and logistics, including comparator sourcing of medicines, packaging, labelling, storage, and distribution services. And we offer strategic advice, design, facilitation, and implementation of global early access programs, and distributes unlicensed and other medicines worldwide.

Our success is based on the motivation, dedication and performance of our people. We strive to go the extra mile and achieve excellence in all our services.

We are hiring for the position of a Clinical packaging and labelling manager to be based in our Windsor (UK) office for immediate start. You will be reporting to a Senior Director, Global Operations and will become part of our growing Global Operations Team. You will work closely with internal and external stakeholders of different business units and departments.

Responsibilities

• Be the subject matter expert for internal and external clients/customers for matters related to labeling, packaging and distribution of clinical materials.
• Be accountable for label compliance with respect to study design and regulatory requirements.
• Be responsible for label design, creation and verification, while maintaining country specific requirements for clinical labels.
• Process customer/client &/or vendor\’s POs or requests on company software.
• Lead/Coordinate all inbound, labeling, packaging and outbound activities with all relevant stakeholders (e.g. warehouses, labelers, couriers, brokers, customers, vendors etc.).
• Creation and processing of inbound, labeling, packaging, and outbound shipment documentation.
• Manage all project based invoicing activity.
• Proactively follow up on vendor and customer lead times, updating systems and stakeholders, as necessary.
• Maintain trackers (program specific, regulatory & patient trackers).
• Update client, regulatory or other related portals with order details, as required.
• Develop an expert understanding of operational details of assigned accounts.
• Manage any order-related issues, e.g. deviations, customer complaints & CAPAs.
• Generate manufacturing protocols and work with QA/QP to action printing of ancillary labels.
• Ensure accurate inventory levels are maintained for assigned projects/programs.
• Collaborate with the commercial team to maintain an effective communication flow with customers.

Qualifications

• University graduate with minimum 4 years’ work experience in supply chain, logistics, or clinical manufacturing organization
• Experienced in labeling, packaging, and distributing temperature sensitive pharmaceuticals
• Profound knowledge of regulations relating to GMP/GDP
• Experienced in working closely with the Quality Department to identify, address and resolve any quality issues, assisting in the conducting of any investigations / implementing of CAPAs where necessary.
• Good relationship with peers, ability to manage time and stress, excellent self and interpersonal motivational skills, project management ability
• Able to maintain a positive, results orientated work environment, building, and improving upon existing partnerships and demonstrate great teamwork, communicating to the team in an open, balanced, and objective manner.
• Meticulous attention to detail and computer literacy (MS Word, Excel, Power Point and Outlook).
• Able to work under pressure.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Information Technology

Industries

• Pharmaceutical Manufacturing