Do you want to help ensure quality in Life Science together with the industry's sharpest minds? Then this is the place for you. Here you can expect assignments that require curiosity, drive to solve problems and sharp expertise, and that give you the chance to develop in new contexts. Together we contribute to a better tomorrow and shape tomorrow's solutions that make a difference for people and society.
This will be your role
We are looking for a senior validation leader or expert who wants to take a central role in our most business-critical projects within Life Science. You are responsible for ensuring quality, regulatory compliance and success in customer assignments – from strategy to implementation.
You will become part of Quality & Validation within our Compliance business area – a team with a strong mix of expertise and curiosity. Here you work closely with colleagues with similar experience levels, while sharing your knowledge and mentoring more junior consultants in their development.
The role involves:
Ensuring that regulatory requirements and standards according to GMP/GxP are complied with and thereby contributing to successful, safe and sustainable projects.
Develop validation strategies and prepare and quality assure validation documentation.
Qualify and validate computerized systems in complex environments.
Drive cross-functional work with requirements definition, risk management and quality assurance, as well as coordinate validation activities and lead resources in larger projects where close collaboration between customer and colleagues is crucial for results.
Handle deviations, CAPA and change requests in a structured and solution-oriented manner.
Act as an advisor in customer projects and serve as a mentor and trainer to share your experience and contribute to the team's development.
We have offices in several locations in Sweden, this position is based at our office in Kista.
This is how you will excel
You are a confident and business-minded consultant who builds trust in customer relationships and drives work forward with structure and quality.
You thrive in complex environments, take responsibility all the way to the goal and enjoy sharing your knowledge. Combining technical depth with a solution-oriented approach comes naturally to you – as does contributing to both the team's and the business's development.
To succeed in the role, you have:
Higher education or equivalent in a relevant field.
At least 5 years of experience in Pharma/Biotech and working according to GMP.
Solid experience in validation of computerized systems (CSV).
Knowledge of GAMP and experience with systems such as eQMS/ERP/LIMS, FMS or Historian.
Experience working according to different quality management systems and in electronic systems for document and case management.
Very good knowledge of Swedish and English.
Experience with additional regulations and guidelines is a merit.
Being part of Team PV
With us you get something different.
We don't recruit for a specific assignment – we recruit to build our team long-term. That means we look at you, your expertise and your development over time, and create the right conditions for you to continue to grow.
We work as an advisory partner to our customers and value long-term relationships – both externally and internally. In the team there is a strong culture of knowledge sharing, where senior consultants learn from each other and contribute to the whole.
Our culture is something we are truly proud of. We are a Great Place to Work, year after year – and we see it as a testament to the environment we build together every day. And yes – if our culture had been embedded in the walls, they would have been soft.
Application
Welcome to submit your application as soon as possible. During holiday periods, it may take a while before you hear from us – we start selection and interviews as soon as we return from the holidays. If you have questions about this position, please contact Ida Holmberg at 076 108 84 87 or [email protected]
Do you have your own company and are interested in collaborating with us as a subcontractor? Instead of applying for a specific position, feel free to connect with us via our careers page and indicate that you are interested in working as a subcontractor – we will get back to you when something suitable comes up.Do you want to help ensure quality in Life Science together with the industry's sharpest minds? Then this is the place for you. Here you can expect assignments that require curiosity, drive to solve problems and sharp expertise, and that give you the chance to develop in new contexts. Together we contribute to a better tomorrow and shape tomorrow's solutions that make a difference for people and society.
This will be your role
We are looking for a senior validation leader or expert who wants to take a central role in our most business-critical projects within Life Science. You are responsible…