Intern, External Quality Assurance (Hybrid)

Job Description

The Position

External Quality Assurance is set up to have quality oversight responsibility on external partners that manufacture and supply Active Pharmaceutical Ingredients and Formulated Drug Products to Organon. While there are regional and platform quality leads within the organization, the incumbent would primarily be working with the External Site Quality Lead (ESQL) as their key internal point of contact.

The intern will support the External Site Quality Lead in day-to-day quality operations such as management of ad-hoc and routine Regulatory requests. This includes routine communications with external partner contacts to send and receive Quality related information such as Regulatory CMC documentation required by Organon. They will also liaise with Organon CMC contacts or other Organon functional team members to ensure that correct documents have been received from the external partner. It is also expected that the person will propose better ways of working to streamline the Regulatory CMC request process by collaborating with key stakeholders. The intern will also support ESQL in implementing Quality agreement requirements with external partners including Quality metrics, Annual Product Reviews, Complaints, Deviations, and other applicable Quality Management Systems.

Learning Outcome:

The incumbent should be able to gain exposure to working in external/contract manufacturing space in the Pharma industry. The role offers hands-on experience in dealing with internal and external stakeholders that would enable sharpening of communication and collaboration skills as well as learning how to negotiate to achieve a win-win solution for day-to-day problems.

What you can expect:

• Join a global organization that prides itself on high integrity, ethics, and quality
• Work along with a collaborative team
• Gain insights into the External Quality Assurance workings of a Global Healthcare organization
• Gain mentorship and teachings on valuable soft skills in a corporate setting

Required Education, Experience, and Skills:

• Pursuing a degree in Science stream with preference in Pharmaceuticals
• Proficient in verbal and written communications in English
• Well-versed with the use of MS Office
• Team player

The person will be based out of the Organon office or be working from home full time (preferred) or part time.