Packing and Labelling Operations Manager
6 days left
- Experience Level
BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations, with a presence in the UK, USA and Germany.
We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service. Our culture is one of openness, honesty, and respect. Our goal is to become a Global Leader in the Clinical Trails Supply Industry.
We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, our future is exciting, come join us!
BAP have an amazing opportunity for a Packing and Labelling Operations Manager to join our growing and busy team in our Höchstädt facility in Germany.
This role is position is responsible for the day to day managing of the Operations team to ensure overall GXP compliance with all procedures associated with receiving, storing, label production, packaging, release of clinical supplies, distributing, returns processing, comparator supplies, and project management.
- Oversees all GXP activities related to receiving, storing, label production, packaging, release of clinical supplies, distributing, returns processing, comparator supplies, and project management.
- Supervises the Operations team to ensure the management of all medicinal products and ancillary materials, and the material flow of these goods, as well as the operational activities that support the maintenance of the facility and use of equipment.
- Develops and maintains packaging room schedules to identify timelines as to when jobs will be executed and assignment of appropriate personnel to each room.
- Assists with the creation and revision of SOPs.
- Assures that qualified individuals are GXP trained to perform their respective job relative to handling and/or processing of clinical supplies.
- Ensures that all Operations personnel adhere to all policies and BAP Pharma SOPs in accordance with GXP and as specified.
- Coordinates with Quality Assurance to maintain GXP and BAP Pharma SOP compliance within the Operations group.
- Participates in planning meetings and initial study discussions with clients regarding packaging designs and project tracking meetings.
- Oversees the material specification process.
- Oversees the acquisition of materials for use in clinical studies, including cartons, labels, etc.
- Oversees the label text approval process, including the creation of text within the BAP Pharma label printing system and ensure that clients have approved all necessary label proofs.
- Oversees the label production, label inspection and label accountability processes.
- Oversees the randomisation approval process, including the creation of packaging samples.
- Ensures adherence to standards of personal and packaging safety.
- Oversees and approves the creation and revision of shipment documentation as appropriate.
- Coordinates activities between internal departments and clients.
- Communicates with third party suppliers regarding sub-contracted services.
- Investigates and resolves quality related issues in coordination with Quality Assurance department.
- Maintains close contact with clients, couriers, custom brokers, in addition to domestic and foreign shipping regulation organisations.
- Coordinates with other departments to meet project timelines.
- Negotiates with suppliers to ensure product relevance and cost-efficiency.
- Collaborates with the on-site Maintenance Manager and Quality Assurance representative/s to adhere to the preventative maintenance schedule as specified.
- Participates in client and/or ROB audits, as required.
- Partakes in client visits as appropriate.
- Ability to read communication styles of team members and contractors who come from a broad spectrum of disciplines.
- Able to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments.
- Ability to defuse tension within a project team, should it arise.
- Able to bring a project to successful completion through political sensitivity.
- Performs other duties as required.
- BSc in pharmacy, chemistry, biochemistry, or related scientific discipline.
- Substantial experience (> 5 years) in clinical trials supply is essential.
- Robust knowledge of the pharmaceutical industry and GXP.
- Managerial experience of operational teams is essential.
- Must be fluent in English and German with excellent written and verbal communication skills.
- Excellent numeracy skills.
- Strong computer literacy skills.
- Experience of working independently and in a team-oriented collaborative environment is essential.
- Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
- Excellent interpersonal skills.
- Must be able to learn, understand, and apply new technologies.
- Able to present relevant material internally and externally, lead meetings and participate in training sessions.
- Ability to effectively prioritise and execute tasks in a high-pressure environment is crucial.
This role reports to the Managing Director. Overtime may be required from time to time to meet project deadlines. You must have the ability to work under own initiative and as part of a team. We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.
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