Arbetsbeskrivning
Are you an experienced QA Specialist with a passion for quality? Do you love working cross-functionally with colleagues to develop processes and find better, more efficient ways to work? Are you dedicated to make an IMPACT in the life of others? Sound like you? Then you should consider joining us at Magle!
As a QA Specialist at Magle, you will play an important role in the business, enabling us to bring life-changing healthcare innovations to patients. Magle Chemoswed produces both APIs and Medical Devices, supporting customers worldwide. You will be assigned to different projects to represent the quality team, ensuring that our high-quality products are key to our success.
To succeed in the role of QA Specialist at Magle, you should enjoy working both independently and with others. Strong collaboration and communication skills are crucial for this position. You should also feel comfortable in a changing environment and be able to adjust your work depending on business needs. We are looking for someone who is organized, driven, efficient, and capable of explaining and supporting the organization in quality matters.
Key Responsibilities:
Review batch documentation.
Release APIs and Medical Devices.
QA approval of Standard Operating Procedures (SOPs).
Participate in improvements.
Manage changes, deviations, and complaints.
Provide customer support.
Participate in customer and regulatory inspections, investigations, and risk assessments.
QA encompasses a broad range of tasks, offering opportunities for development in various areas.
To succeed in this position:
Experience from Quality work for 5 years or more.
University degree in chemistry, pharmaceuticals, or an equivalent engineering discipline.
Previous work experience in pharmaceutical or Medical Device operations according to GMP and ISO 13485.
Excellent proficiency in both Swedish and English, spoken and written, as both languages are used in the job.
Experienced user of Microsoft Office and a Q Management system.
Experience in QA work for projects in clinical phases is highly advantageous.
Beside competence we are a value driven organisation and you need to share ourambition to work to make anIMPACT for patience. We know we can make a difference by setting our mind to being Innovative - Motivated - Positive - Accountable- Customer focused and work as aTeam.If you belive you share our values andthe above position fits your experience, we would love to hear from you.
We know it a vacation period for many, and we hope you are enjoying the summer. We therefore have a bit longer time for applications to be completed we would however like your application no later thanAugust 12th. If this is the position you been waiting for don't hesitate to send us your application so we can start to get to know each other.Please submit your CV and a short cover letter. The position is based at our office in Malmö and is a full-time position.
To find out more about us, please visit our group webpage at www.maglegroup.com.