Job Description
JOB DESCRIPTION: INTERN, EXTERNAL QUALITY ASSURANCE
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 External Site Quality Lead (ESQL) as their key internal points 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 contact, or other Organon functional team members to make sure 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 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 use of MS Office
- Team player
The person will be based out of Organon office or be working from home full time (preferred) or part time
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
No relocationVISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
