Quality Assurance Investigation Specialist

Are you an experienced Quality Professional who thrive in an international, multi-cultural environment where things are constantly changing? Then you might the person we are looking for!

Job Description

We are currently looking for self-driven, positive and proactive team-player to join the QA LSM Operation PMD team in Hillerød. The team consists of 7 employees with whom you will work very closely, and this team forms part of the QA LSM Operations department, consisting of 37 employees with primary responsibility for release of Drug Substance (API) as well as daily support of our large-scale manufacturing facility and related functions.

Primary Responsibilities
• Act as primary QA contact for external customers/partners regarding day-to-day operational activities and for all Biogen project team involved in the partner collaboration
• Participate in partner Business Review Meetings
• Support review and approval of documentation, deviations, CAPA’s etc. for the partner programs
• Assess all changes related to the partner programs to ensure a proper review of changes that impacts regulatory requirements and product quality
• Support the annual product review for the partner programs
• Perform timely QA review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols/reports, risk assessments and sampling plans
• Participate in partner audits and competent authority’s inspections in regards to the partner programs
• Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as global procedures, guidelines, policies, frames, and specifications

You will work in an international and highly dynamic environment, including collaboration with other internal sites and external partners.

Qualifications

We are looking for a strong team player who can also work independently and who is able to build a partnership relation with stakeholders at all levels. Other skills required:
• Minimum 5 years’ experience from biotech or pharmaceutical industry
• Knowledge of Good Manufacturing Practice (GMP)
• Good at making decisions (risk based approach)
• Strong English verbal and written communication skills
• Demonstrate trouble shooting skills
• Ability to take ownership and responsibility for your assignments
• Positive and pragmatic attitude with focus on priorities and delivery on time

Education

• Master of Sciences or PhD in Pharmacy, Chemistry, Biotechnology or similar


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