Quality Specialist
4 weeks ago
Primary Purpose / Regulatory Responsibilities:
The goal of this function is to support the Quality Management Systems in the U- U.S. Affiliate, including but not limited to the following:
- Ensure global quality practices are integrated in the affiliate to ensure compliance is met regarding U- and local regulations.
- Maintain the GXP status of the affiliate in accordance with national and international GMP and legal requirements.
- Ensure QA deliverables are achieved in a compliant timely manner.
- Support Local Quality Lead in tasks.
MAJOR RESPONSIBILITIES
- Ensure implementation and maintenance of the local Quality Management System elements listed below to drive compliance of all relevant cGXPs with local/International regulatory requirements and U- global standard operating procedures.
- Quality Management Review
- Quality System Monitoring
- Document and Record Management
- Deviation Management
- Investigation Process
- CAPA Management
- Change Control Management
- Product Complaint Management
- APQR
- Local Vendor Management
- Product Returns
Others
- Provide support, as deemed necessary, to the Quality Lead and Quality Partners or execute the QMS tasks not listed above under oversight from the Quality Lead or Quality Partners.
- Ensure Quality deliverables listed above are completed in a timely manner in accordance with Corporate QMS and KPIs.
- Ensure efficient information flow and effective communication of quality matters within the relevant Affiliate organization to the Quality lead including but not limited to issue escalation.
- Support ad-hoc projects at the affiliate, as needed.
- Support Global projects on quality systems, as needed.
Education Level
Bachelor's Degree, preferably in Biological or Chemistry Science
COMPETENCIES
- Ability to effectively interact with and influence internal personnel on product and quality related matters.
- Possess excellent interpersonal, verbal, and written communication skills.
- Ability to manage complexity and multitask.
- Ability to analyze data and information to draw conclusions and make effective decisions and escalate as required.
- Self-motivated team player, who can support new ideas.
- The ability to work effectively with minimum supervision.
- Possess root cause and risk management/assessment skills.
- Fluent and confident use of English language verbally and in reading & writing.
- Experience using Microsoft Office Suite applications (e.g., Excel, PowerPoint, Word).
- Working knowledge of specific applications is desirable (e.g., Veeva, SAP, Trackwise, QlikSense).
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