Quality Assurance Intern
vor 15 Stunden
General Description:
- Gain insight into the responsibilities and various roles in Quality (both commercial and clinical) and other departments in Basel, understand the importance of GxP (GMP, GDP) regulations and requirements and their impact within pharmaceutical industry.
- Gain insight in different areas across various countries - mainly Europe - for management of clinical trials.
- Get insights in tools and systems used for a Pharmaceutical Quality Management System
- Provide ongoing support by becoming familiar with the day-to-day quality operations
- Perform other support tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines
Essential Functions of the job:
- Support and interact within project teams to ensure all data, documentation, and information are compliant and have no gaps.
- Create / update / maintain assigned SharePoint lists and / or Manufacturing Oversight via PowerApps/Sharepoint.
If experienced in PowerApps and Power FX, Power Automate help improvement and extension of an available solution to increase oversight and efficiency for the management of daily activities.
- Support maintenance of the electronic quality systems
- Supporting Quality reviews of documents and assist with issue resolution
- Track project/product reports and status metrics and support Quality Management Review
- Schedule, track, and assist with running of meetings; create meeting summaries
- Perform other duties as assigned within Europe Quality as applicable and according to knowledge level
Supervisory Responsibilities:
- none
Computer Skills:
- Microsoft PowerApps and Sharepoint knowledge is a plus
Other Qualifications:
- Ability to work in a global team environment as well as independently in a fast-paced environment
- Good organizational, time management and communication skills
Language: Advanced English and/or German and/or French are beneficial
Education Required:
- Undergraduates, Masters or PhD students in a scientific, medical or healthcare discipline
- Availability to work full-time, for 10-12 weeks during summer period
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Proficient in Microsoft Office, Internet and willingness to work in internal systems such as Veeva Vault after appropriate training.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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