Aptio Group is a leading company delivering highly qualified services to customers with regulatory or industry requirements, such as Pharma, MedTech, e-Health, Food and Automotive. With deep industry experience, excellence and a unique delivery model with collegial engagement, the company increases the customers’ competitiveness.

Our mission is to use the combined competence of our employees to bring the best solutions to our customers. Our goal is to become the best consulting company that can offer the smartest, most efficient, and far-sighted solutions to various problems within regulated businesses. We are also a company that involve our employees in the development of the company through “employeeship” and servant leadership.

Everyone in our team at Aptio Group has many years of experience, all our consultants are specialists. Together, we build a strong team and cover many areas of expertise from regulated industries.

We see all employees as valuable assets and believe in collegial growth and support. Today we are more than 150 expert consultants. Our Swedish offices are located in Malmö (20 consultants) and Gothenburg (7 consultants), our Danish office in Hillerød (60 consultants + approx. 30-50 sub-consultants), and we also have a newly established office in Zug in Switzerland. We are now looking for new colleagues to join our team in Malmö.

For more information about Aptio Group, please see https://aptiogroup.com/se/

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TILLSATT - Senior consultant - Life science


Company: Aptio Group
Position: Senior Consultant – Life science
Reports to: Business Development Manager
Location: Malmö (District South Sweden)


A consultant at Aptio Group is an expert advisor, a person who works as an advisory specialist in a certain field e.g., QA & Compliance including RA. To become this specialist, we believe you have experience from having worked in a certain area for a number of years and accumulated skills and lessons learned. It is also an advantage if you have been in different workplaces and faced different challenges in various organisations. Questions and situations may appear differently depending on the surrounding circumstances.

For the customer, hiring a consultant from Aptio Group will mean more than just hiring a specific consultant. Our consultants always have another colleague as designated back-up and sparring partner. As colleagues, we help each other to give the customers the advantage of our collective expertise. As an employee you will be partly responsible for all our deliveries and support your colleagues. Our services and our vision are increasingly appreciated, and we are now aiming to expand our team even further with new colleagues.

You will have the opportunity to work with a wide variety of tasks with a broad scope of responsibilities, all related to quality and compliance in Life Science. The role involves close interactions both with customers and internal colleagues. Therefore, we are looking for someone who enjoys customer interactions and with ability to adapt to the team and to support and care for others. This puts high demands on the understanding of different company cultures and great diplomatic skills.

For this role, we are looking for a highly skilled and motivated person with solid experience, a flexible mindset and ability to find solutions within given framework. In addition, you need to have analytical, communication (oral and written) and leadership/planning skills as well as being solution oriented.

Since we encourage active participation in developing Aptio Group’s services to our customers we also appreciate the ability to produce new ideas, approaches, or insights.

You will report to the Business Development Manager in Malmö.


Job responsibilities

As a consultant at Aptio Group, you are an expert advisor to our customers. You can also be an interim manager or project manager within the different areas listed below as well as part of a line organisation e.g., as a QA-specialist handling regular tasks. There is also an opportunity to be involved internally in developing new services to our customers at our R&D function (“Tankesmedja”).

Tasks may include, but not limited to:

• Quality Support
o Support for CE marking
o GAP analysis to conform with the CE marking regulation
o Identify necessary QMS (Quality Management System) procedures
o Classification of medical device
o Quality review of development documentation
o Auditing (external/internal)
• Regulatory Affairs
o Main responsibility for all activities that can arise within RA and support in Quality Assurance and Pharmacovigilance
o Providing regulatory strategy input in for new products / new markets
• Validation
o Several tasks for building new production facilities, transferring product between sites, upgrading a filling line
o Upgrading the building management systems, SOP’s etc.
o Computer Systems Validation (CSV) – support, structure etc.
o LIMS
• Serialization
o Specify requirements for introducing serialization and aggregation on a number of production lines on the site
o Produce test documentation and oversee/perform testing to demonstrate that the production lines and the serialization system as a whole fulfil the requirements
• Risk management
• Change management
• Documentation
• Capacity study and Constraint Management
• Training & Education


Education, experience and qualifications

Everyone in our team at Aptio Group has many years of experience, together we cover a large area of expertise. As a specialist, you must be able to adapt the solution to the questions posed based on given conditions. Therefore, we aim for at least 5-10 years of experience from the Life Science industry.

• Academic degree in relevant scientific or technical field. Alternatively, other relevant work experience.
• 5-10 years of experience from the Life Science industry
• Fluent in Swedish and English, orally and in writing 
• Experienced user of MS Office package


Required skills and personal characteristics

• Demonstrates an interest in and understanding of others; Listens, consults others and communicates proactively
• Ability to create good relationships with customers and staff, build extensive and effective contact networks within and outside the organization. Handle conflicts.
• Apply specialized technical expertise. Write clearly and accurately in a well-structured and logical manner to meet the needs and understanding of the recipient.
• Produces new ideas, approaches or insights and a range of solutions to problems
• Ability to adapt to changing conditions


Other

As a consultant at Aptio Group you will be partly responsible for all our deliveries and to support one's colleagues.
The position as Senior Consultant will be based in Malmö working from customers’ site or from home.


Opportunities with the role

This is an opportunity to work at a committed and dynamic consultancy company with an entrepreneurial work environment. You will be involved in a wide variety of tasks and customers, contributing to the customers‘ success, always surrounded by expert colleagues for support. The collegial engagement is an important part of our working model.

Also, you can further develop your skills and expertise in areas of your interest. At Aptio Group it is important with a good work life balance, and we strive to find the best solution for everyone.


Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment Consultants at PeakSearch.

E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379


Application

Apply for the position at www.peaksearch.se