Senior Specialist Qrp

7 months ago

Ho Chi Minh City, Vietnam Organon Full time

**Responsibilities**:
The following core responsibilities are generally applicable to the In-Market Quality, or Quality Responsible Person (QRP) role in the countries (Vietnam):

- Responsible for all quality activities related to GSP FIE warehouse (Pharmaceutical products and medical devices)
- Ensure regulations pertaining to Quality and Compliance for importation, storage, distribution and wholesaling of the products on the markets (e.g. Good Storage Practice) are fulfilled (where applicable as per the country distribution model)
- Where applicable, ensure adherence to the Company’s Quality Management System (QMS) and provide feedback to the Company’s QMS topic Manual Chapter owners
- Health Authority (HA) interactions and notifications regarding Quality issues
- Information and interaction with local business and regional Quality Management
- Ensure Quality perspective is brought into local business initiatives with Quality impact
- Local coordination and execution of recalls
- Product quality complaint related such as CAPA follow up, HA notification etc.
- Primary contact for the countries for the Company’s Quality function
- Primary contact for the countries for HA issues pertaining to Quality issues
- Local batch release for distribution

**Required Education, Experience, and Skills**:

- Bachelor of Pharmacy degree.
- Proficient in English
- Must be a locally registered pharmacist with a valid registered pharmacist license.
- Must have expertise and broad experience in Quality area (GMP and GDP), with at least 2 years of professional practice at an appropriate pharmacy establishment. Experience in Supply Chain or Regulatory Affairs is advantageous.
- Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
- Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity and ambiguity
- Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams.

**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.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**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
**Requisition ID**:R524299

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