Sr. Associate for Quality Assurance, Systems & Support - Denmark
- Do you want to work for a company that develops, markets and produces medicine that help patients all over the world suffering from diseases such as Multiple Sclerosis, Alzheimers, and Parkinsons? And do you thrive in a role where you will provide oversight and direction for review and approval of GMP-related documents and records that support manufacturing and clinical operations?
- Then the opportunity as Sr. Associate in company’s Quality Assurance Systems & Support team might be your next step.
- The Quality Assurance Systems & Support department consists of two teams which are characterized by working dedicated together and with counterparts across company’s subsidiaries globally; the Record Life-cycle Management (RL) team and the Quality Management System (QMS) team.
- You will work in the QMS team with five colleagues on issuing documents, archiving, and routing new documents including improving the process and system knowledge behind.
- You will also be a central player during prep and hosting of Audits and Inspections.
- Many of us have been with company for some time and we all look forward to welcoming a new colleague who will also contribute to the positive spirit and dedicated approach that characterize our team.
- We are also open to bringing a colleague in who has an eye for process improvement and can help us develop features and flows that will make our work easier in the long-term.
- Thus, we offer you to take part in driving our effort to increasingly digitalize our processes; perhaps even drive some of the department’s projects yourself.
The principal accountabilities of this job are to:
- Facilitate the document change control process from initiation through document effectivity.
- Review and may provide final Quality approval of Standard Operating Procedures (SOP’s), Forms, Master Production Records (MPR’s), and Solution Lot Records (SLR’s) related to Manufacturing/Packaging operations
- Provide training to Site personnel on departmental SOP’s, Quality Systems documents and Qualifying Events as related to QA
- Provide QA representation and guidance for manufacturing on issues related to Documentation and Compliance.
- Provide technical assistance to manufacturing operations as related to compliance requirements
- Lead department projects and participate in Global Documentation Quality system teams/projects and devise implementation plans
- Develop, review and implement improved practices and procedural-based documents.
- Demonstrate ability to resolve issues with customers independently with a commitment to customer service.
- Revise and perform biennial review of procedural-based documents
- Lead internal/self-inspection audits to assure cGMP compliance.
- Provide QA support and representation for documentation procedures during Regulatory inspections.
- Minimum 5-8 years of experience in a regulated environment.
- It is a plus if you have an ASQ certification or an ISPE, PDA membership or equivalent.
- You demonstrate experience in working in a Quality Management System.
- Fluency in English is required; ability to speak and write Danish is a plus.
You have a BA degree in a science, IT or a relevant business discipline.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
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