Job Description

1.Key roles and responsibilities:

• Support China quality lead for quality management system’s implementation and maintenance to make sure it’s complaint to company QMS and local regulation requirements.
• Be responsible for product local release activities to ensure timely delivery of products.
• Be responsible for new product launch support from quality’s perspective.
• Provide support to ensure related process is in place which meets drug and MD GSP requirements.
• Provide support to set up quality system for Domestic Responsible Entity which meets DMAH regulation requirements.
• Support inspection / Audit readiness to ensure Health Authority inspections and Divisional inspections.
• Conduct the company quality system internal audit, investigation on the audit findings and CAPAs development for quality management system continuous improvement.
• Communicate with 3PL to ensure the product quality during storage, maintenance and transportation, etc.
• Be responsible for drug Annual reporting process and working with RA, PV and SCM etc., to make sure timely submission
• Perform other related duties as assigned by management.

2.Minimum qualifications, skills and experiences

• At least have bachelor’s degree of pharmaceutical or related education background
• At least 5 years of experience of quality, compliance or other relevant experience in pharmaceutical industry
• Prefer to have working experiences in MNC pharmaceutical Drug Distribution company
• Effective English skills for communication in verbal and writing
• Effective communication skills

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:

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:

Requisition ID:R534423