QA Manager

at  Orion Corporation

DESCRIPTION OF POSITION

As the QA Manager, GVP (Good Pharmacovigilance Practices) you are responsible for quality assurance in pharmacovigilance. Your duties include planning, conducting and monitoring internal and external audits and you actively participate in regulatory authority inspections and partner audits. You are involved in approving pharmacovigilance SOPs, deviations, CAPAs and change management. You monitor international regulatory authority guidances, and provide support, advice and training in GVP.
The location of this permanent role is in Espoo.

DESCRIPTION OF UNIT

R&D QA is part of Quality Management organisation and is responsible for quality assurance in R&D and pharmacovigilance. Main tasks of R&D QA include assuring that processes comply with GxP requirements and are continuously developed, internal and external auditing of GxP activities and monitoring regulatory authority guidance.

REQUIREMENTS

To be successful in this role, you will need:

• University degree in e.g. pharmacy or life sciences
• Experience in pharmaceutical or medical device industry
• Experience in pharmacovigilance and/or quality assurance and auditing
• Good co-operation skills, but also capability to work independently
• Readiness to take responsibility and willingness to develop processes further
• Strong interpersonal skills and the ability to positively influence and guide others
• Excellent problem solving, risk analysis and negotiation skills
• Ability to manage multiple activities and timelines, and see both the big picture and pay attention to the details
• Fluency in written and spoken English
• Fluency in IT skills and e.g. experience from document management and quality management systems used in pharmaceutical industry
• Readiness to travel abroad occationally

#LI-ORION

Orion Corporation operates in more than 30 countries, where we Orionees, 3600 in total, work in all kinds of positions. Among us there are Research Scientists, Laboratory Technicians, Engineers and IT Specialists as well as people working in Production, just to mention some examples. We offer diverse and responsible jobs to our personnel in a truly multi-disciplinary work environment. We encourage people to develop their competences and offer opportunities to affect the job description and creating their own career path at Orion. We are searching for top talents who are ready to share our passion for the work that we do

• University degree in e.g. pharmacy or life sciences
• Experience in pharmaceutical or medical device industry
• Experience in pharmacovigilance and/or quality assurance and auditing
• Good co-operation skills, but also capability to work independently
• Readiness to take responsibility and willingness to develop processes further
• Strong interpersonal skills and the ability to positively influence and guide others
• Excellent problem solving, risk analysis and negotiation skills
• Ability to manage multiple activities and timelines, and see both the big picture and pay attention to the details
• Fluency in written and spoken English
• Fluency in IT skills and e.g. experience from document management and quality management systems used in pharmaceutical industry
• Readiness to travel abroad occationall