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Quality Assurance Manager to expanding Life Science company

Are you eager to develop yourself in a fast-paced environment? Do you thrive on challenges and want to be a critical player in our ongoing growth journey? Look no further - the operations team at Niconovum AB is looking for a new QA Manager.

The Company

Niconovum AB is a Sweden-based pharmaceutical company that markets innovative nicotine replacement therapy (NRT) products under the Zonnic brand. Our products are sold in Sweden, Norway, Finland and Iceland, and the Zonnic brand is #3 in terms of market share in each market – but gaining share every quarter. The company is experiencing very strong growth and is now in the process of setting up a new manufacturing facility in Ystad, where this role will be based.

The Role

As the Quality Assurance Manager in the Niconovum production organization, you will be reporting directly to the Plant Manager, with an indirect reporting relationship to the Head of Quality for Niconovum based in the Corporate Office in Malmö (Hyllie). You will be part of a group of up to 20 people consisting of technical and operational personnel.

In 2021 and 2022 the focus of your work will be project based to get the new pharmaceutical factory built and approved by the Swedish Medical Products agency. As QA Manager, you will be responsible for overseeing and maintaining the quality and compliance work at the site. You must ensure that the new factory meets the GMP-related requirements and documentation for all operations. You will also routinely interact with internal and external stakeholders, including Niconovum´s Qualified Person to uphold the GMP license.

Main responsibilities include:

•Reviewing and controlling all batch documentation

• Releasing internal processes and intermediates

• Identifying, documenting and following-up deviations and change controls within the quality system

• Investigating product complaints

• Writing and approving SOPs

• Writing and approving validation and qualification documents

• Giving GMP support and following up on compliance

• Developing and executing GMP training

• GMP inspections and audits

• Leading the quality work within the operation at the site, performing risk analysis and maintaining the CAPA system

• Assisting the Head of Quality in developing strategic plans and business cases, as needed

Background sought:

• Bachelor´s degree or Master of Science in a relevant field

• Quality related experience within life science

• Demonstrated experience resolving compliance and regulatory issues, particularly GMP

• Lean, Six Sigma or similar competence or experience

 

We think you are someone who appreciates and initiates structure and routines. And most important of all - quality is always your guiding star.

Niconovum is a small, fast and flexible organization so you must be able to work both on a strategic and operational level. You will interact and communicate on all levels throughout the Niconovum organization. For this, you will need excellent Swedish and English language skills both verbally and in writing. As a person, you must be organized, diligent, and conscientious, with the professional maturity to work independently, but seek input from colleagues when necessary. You are analytical, thorough, detail oriented and with utmost integrity.

And now?

This process is in collaboration with Badenoch + Clark. For any questions regarding the position, please reach out to Senior Consultant Matilda Rodey at [email protected] look forward to receiving your application as soon as possible, at www.badenochandclark.se or using link below. Selection will be ongoing – so contact us today! Visa mindre

Technical Manager for Life Science company
Are you looking for your next career step in the technical field, and ready to develop both your own expertise and the production maintenance of a growing pharmaceutical company? Do you enjoy taking responsibility and putting your multi-tasking skills to good use? Now is your chance to join the operations team at Niconovum AB during its growth phase!

The Company

Niconovum AB is a Sweden-based pharmaceutical company that markets innovative nicotine replacement therapy (NRT) products under the Zonnic brand. Our products are sold in Sweden, Norway, Finland and Iceland, and the Zonnic brand is #3 in terms of market share in each market – but gaining share every quarter. The company is experiencing very strong growth and is now in the process of setting up a new manufacturing facility in Ystad, where this role will be based.

The Role

As Technical Manager in the Niconovum production organisation, you will be working closely with, and report to, the Plant Manager. You will be part of a group of up to 20 people consisting of technical and operational personnel.

The role must ensure that registration, documentation, machine maintenance and machine calibrations are satisfactory and fully compliant with both internal and external requirements. You will be responsible for managing the computerized maintenance system and developing a risk management plan for spare parts and unscheduled service. You will be the contact person and manage relationships with external contractors who perform maintenance and installation work at the factory.
In 2021 and 2022 the focus of your work will be to get the new pharmaceutical factory built on-time and on-budget and approved by the Swedish Medical Products agency.

Main responsibilities will include:
• Ownership of preventive and predictive maintenance for machines and building in general
• Calibrating measuring instruments
• Establishing a network of reliable local contractors
• Engaging experts from the machine manufacturers
• Handling contracts with suppliers and technicians
• Training staff, as needed
• Production documentation, as needed

Background sought:

• Technical training, preferably in life science production environment
• GMP experience
• Knowledge of maintenance systems

Niconovum is a small, fast and flexible organization so you must be able to work both on a strategic and operational level. You will interact and communicate on all levels throughout the Niconovum organization. For this, you will need excellent Swedish and English language skills both verbally and in writing. As a person, you must be organized, diligent, and conscientious, with the professional maturity to work independently, but seek input from colleagues when necessary. Efficient production is of critical importance, so you need to be meticulous, with a strong focus on details and risk identification, with a willingness to take initiative and develop creative solutions.

Your Application
This process is in collaboration with Badenoch + Clark. For any questions regarding the position, please reach out to Senior Consultant Matilda Rodey at [email protected].

We look forward to receiving your application as soon as possible and no later than May 24th, at www.badenochandclark.se or using link below. Selection will be ongoing – so contact us today! Visa mindre

Finance and Logistics manager to thriving Life Science company
Are you eager to develop your career and enjoy all the challenges of a quickly expanding business? Do you have a passion for working with numbers and conducting thorough analyses that you can present and defend with confidence?

Now is your chance! The operations team at Niconovum AB is looking for a Finance & Logistics Manager.

The Company
Niconovum AB is a Sweden-based pharmaceutical company that markets innovative nicotine replacement therapy (NRT) products under the Zonnic brand. Our products are sold in Sweden, Norway, Finland and Iceland, and the Zonnic brand is #3 in terms of market share in each market – but gaining share every quarter. The company is experiencing very strong growth and is now in the process of setting up a new manufacturing facility in Ystad, where this role will be based.

The Role
As Finance & Logistics Manager, you will be working closely with, and directly report to, the Ystad Plant Manager. You will also have an indirect reporting relationship with the Head of Finance at Niconovum, based in the Corporate Office in Malmö (Hyllie).

You will be part of a team of up to 20 people setting up the new facility, which is expected to expand over the next few years. In 2021 and 2022 the focus of your work will be project based to get the new pharmaceutical factory built and approved by the Swedish Medical Products agency. Once the factory is operational, you will be responsible for ongoing finance and supply chain activities.

Main responsibilities will include:
• Internal communication with the sales and marketing team regarding production planning and product availability
• Internal communication throughout the production organisation
• Resource planning and materials sourcing
• Coordinating activities with multiple external service providers (raw materials, components, packaging, transportation, etc...)
• Maintaining close relations with suppliers and service providers
• Full responsibility for the ERP system handling operations, transactions, reconciliations and reporting
• Managing the warehouse and the warehouse employees. Responsibility for the timeliness and accuracy of monthly time reporting
• Managing monthly financial transactions and reconciliations
• Budgeting, forecasting, and financial planning - short and long term
• Risk analysis and management
• Assisting the Plant Manager in key projects, as needed
• Assisting the Head of Finance in developing strategic plans and business cases, as needed

Background sought:
• Excellent knowledge of general finance, project accounting and business analysis, preferably within a production environment
• Previous experience in a Finance/Logistics position - preferably in the pharmaceutical industry
• Advanced knowledge of Microsoft Excel
• Bachelor´s degree in a related field. A Master´s degree is preferred
• Experience with procurement
• Experience with operating companies, including international reporting
• ERP systems experience, including multi-company setup

Niconovum is a small and flexible organisation and you must be able to work both on a strategic and operational level. You will interact and communicate on all levels throughout the Niconovum organisation. For this, you will need excellent Swedish and English language skills both verbally and in writing. As a person, you must be organized, diligent, and conscientious, with the professional maturity to work independently, but seek input from colleagues when necessary.
Does your heart beat a little faster at the thought of this fantastic opportunity? Read on below!

Where do I sign up?
This process is in collaboration with Badenoch + Clark. For any questions regarding the position, please reach out to Senior Consultant Matilda Rodey at [email protected].

We look forward to receiving your application as soon as possible and no later than May 24th, at www.badenochandclark.se or using link below. Selection will be ongoing – so contact us today! Visa mindre