Vacant job

Are you an experienced QA focused on quality assurance of computerized systems within Life Science? Have you built up solid experience and feel ready to take the next step into a senior consulting role at one of Sweden's most sought-after workplaces?

This will be your role We are currently looking for an experienced and dedicated Senior Consultant QA for computerized systems, who will be part of our Compliance business area and the Quality Management unit. With our deep expertise in project management, quality assurance, and validation management, we help our clients implement important business changes. Our clients turn to us at Plantvision for advice from the sharpest minds in the industry – and this is where you come in.

• Your expertise in QA for computerized systems makes you a central player in advisory roles, both as a consultant in the client's organization and in project deliveries.
• You will be challenged and take on exciting assignments and projects within Life Science where your expertise truly makes a difference.

Examples of responsibilities:

• Ensure that regulatory requirements and standards according to GMP/GxP and GAMP are met.
• Conduct risk management and quality assurance within investment and/or improvement projects.
• Provide advice and support in client projects within QA computerized systems and IT.
• Quality management within computerized systems and CSV.
• Review and approve documentation and processes related to computerized systems.
• Develop and update quality management systems (QMS) with a focus on computerized systems.
• Perform supplier assessments and participate in or lead inspections/audits focusing on quality assurance of systems and GAMP.
• Act as a trainer and mentor in quality-related topics.

The role is dynamic and offers you great opportunities for both professional and personal development. With us, we inspire, coach, and learn from each other – that’s when we are at our best. You will belong to one of our offices in Kista or Södertälje but take on assignments throughout the Mälardalen region and be part of a welcoming and caring team that always supports each other.

This is how you will shine It is a given that you as a person are meticulous and quality-conscious, and to succeed in your role with us, we believe you are a positive person with good social skills. You enjoy working together with others and are passionate about learning new things. As a person, you are pragmatic, with the ability to handle complex situations in a solution-oriented way to find the right quality level. Your calmness and stability under pressure allow you to tackle challenges while contributing to a positive environment, regardless of assignments and projects. As a colleague, you enjoy sharing knowledge and supporting colleagues, and you have a strong ability and willingness to coach or mentor more junior colleagues.

In addition to the above qualities, we also see that you have:

• At least 4 years of post-secondary education or equivalent in a relevant field
• At least 5 years of experience in quality assurance according to GMP/GxP within Life Science, of which 3 years of experience in quality assurance of various types of computerized systems /CSV and knowledge of GAMP (e.g., production/process-related systems, lab-related systems, IT systems such as eQMS/ERP/LIMS; FMS; Historian; Data migration).
• Experience working according to various quality management systems and have worked in electronic systems for document and case management.
• Experience in developing and updating quality management systems.
• Developed validation and risk management strategies for computerized systems.
• Fluent in Swedish and English, both spoken and written.
• Desirable qualifications:
• Experience with other relevant GxP regulations.
• Experience in validation of computerized systems (CSV).
• Experience in supplier assessments and accustomed to participating in or leading inspections/audits.

Being part of Team PV We are very proud to be a certified Great Place To Work company, which places us among the best employers in Sweden. Being on the top list of Sweden's Best Workplaces is a testament to our success in creating a fantastic culture together.

We are not like everyone else – we are unique with our deep expertise and industry knowledge combined with our warm passion and our community that cares for each individual. We are a workplace that is more than just a job. And the key is us who work here. We have an extraordinary commitment and love to share our brilliant ideas. We engage in what we believe in, and we do it wholeheartedly. We have the energy of a small company combined with the calm that only a company with our long experience can feel. We want to develop. We want to move forward. Together for a better tomorrow, that’s Team PV. If you want to know more about what it’s like to work as a consultant with us, read more here: Gunilla Höög | Plantvision (https://plantvision.se/karriar/berattelser/gunilla-hoog/)

Application If you believe that we are the right workplace for you and that you are right for us, submit your application today! Selection is ongoing and start date is by agreement. If you have questions about this position, feel free to contact Karin Tördahl at 0725-66 87 98, karin.tordahl@plantvision.se.