Quality Assurance Specialist (m/f/d)

Job Description

At Organon we have an exciting opportunity for a Quality Assurance Specialist to join our team in Munich, Germany. This role is mainly responsible for the Maintenance of the training and document management system as well as handling the change control system and preparing APQRs.

Responsibilities 

• Support the management, further development and oversight of the quality management system e.g.: documentation system, change control, deviation, CAPAs, product quality complaints,  

• Management of the training system  

• Preparation and/or review of APQRs 

• Support the performance of self-inspections and related follow-up activities 

• Handling GDP-related topics with relevant stakeholders, including but not limited to: evaluation of temperature excursions, support of annual Transport Lane Risk Assessments, supplier qualification/quality oversight of external service providers, including third-party logistics (3PL) and preparation/revision of quality agreements, 

• Preparation and participation in global audits and Health Authority inspections 

 

Required Education, Experience, and Skills 

• Master Degree in Pharmacy, Chemistry, (Micro)Biology, Chemical Engineering (or equivalent). 

• 1 to 3 years in the pharmaceutical industry, with Quality Assurance experience in GDP/GMP environment  

• GDP (Good Distribution Practice) knowledge and understanding of GMP. 

• Fluent in German and English (oral and written). 

• High sense of responsibility, accurate attention to detail, and team player skills.  

• Strong communication skills, willingness to learn and develop.  

• Organizational skills 

• Authentic, empathetic, curious, and courageous. 

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:

Regular

Relocation:

No relocation

VISA 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