Job Description

The Position

The Quality Assurance Specialist is a professional responsible for quality and compliance responsibilities.

The Quality Assurance Specialist will support the structure of the In Market Quality and the way quality services are delivered, joining a team of peers based through EEMERA region. Furthermore, he/she will play an important role in providing significant value to the organization by ensuring state of the art for quality, operations excellence, regulatory compliance, while action as a contact person to multiple stake holders. Region of responsibility will cover: Czech Republic, Slovak republic, Romania, Bulgaria, Poland. Other countries can be added based on the potential changes on IMQ organizational changes within EEMERA cluster.

Responsibilities

The following core responsibilities are generally applicable to the Quality Assurance Specialist

• Ensure all applicable laws and regulations in region pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets are fulfilled (where applicable as per the country distribution model)
• Where applicable, ensure adherence to OMS Quality Manual and provide feedback to OMS Quality Manual Chapter owners
• Information and interaction with local business and regional Quality Management.
• Works closely with Regulatory Affairs and Customer Service departments to resolve open issues (PQCs, quality issues)
• Notifications regarding quality and supply issues
• Ensure Quality perspective is brought into local business initiatives with Quality impact
• Support in coordination and execution of recalls
• Management of PQCs and quality defects for defined market within EEMERA region
• Review and assess Corrective and Preventive Actions and Change requests
• Reviews and assesses deviations includes tracking, follow-up and reporting, deviation trending
• Ensure Quality Risk Management Support in management of PQRs (where applicable) and Technical Quality Agreements
• Assists in performing and reporting internal and vendor audits as scheduled
• Participate in Regulatory Inspections

Required Education, Experience, and Skills

• Master of science in Pharmacy
• Training in area of Pharmaceutical Quality system with the focus on Supply chain and legal responsibilities of QP/QRP
• Experience in working with management in multi divisional structure
• Experience within pharmaceutical industry
• Good communication skills both verbal and in writing
• Organizational awareness

Preferred Education, Experience, and 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:R533218