Job Description

Quality Assurance Specialist, In Market Quality

 

Full time, full day

 

You will be a part of Distribution & In-market Quality Team responsible for activities related to Good Distribution Practice (GDP), license maintenance and local batch release process for Russian market, quality support for CIS markets

 

Main responsibility:

Assure compliance with established Company’s policies/procedures and comply with all applicable governmental regulations (GMP, GDP, local legislation, etc.)

Maintain the local Quality Management System

Participation in Audits and Self-inspections

Ensure Quality training of personnel including assessment of training effectiveness

Complete trainings as required for role

Handling of product quality complaints (PQCs)

Participation in deviation management, overview and tracking, handling of temperature excursions during transportation, warehousing and distribution

Participation in CAPA management, including tracking

Participation in local recall coordination and execution

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Local batch release (routine and one batch per year) – AIS RZN, release in SAP

Collaboration with laboratories

Coordination of product testing between manufacturing site and CIS state laboratories, including management of any resultant investigations or queries

Quality Agreements with providers and KPIs monitoring

Product Quality Reviews

 

 

Qualification

 

Education:

·                  University Degree in a relevant science (preferably BS Pharmacy, Chemistry, Chemical Engineering, Biology (or equivalent) education)

·                  Basic knowledge of normative documentation, medicines state registration process, local pharmacopeia articles

·                  Basic knowledge of quality confirmation/local certification

·                  Experience and knowledge in the field of logistics (importation, customs clearance, warehousing, transportation including cold chain)

·                  Experience in the field of GMP/GDP and other applicable local legislation is preferable

 

Skills Required:

·                  At least 2 years’ experience in the pharmaceutical industry preferably with knowledge of Quality Systems, Quality Assurance and Quality Control including basic knowledge of global GMP/GDP and regulatory requirements.

·                  Strong compliance mind-set, motivation, communication and negotiation, multi-task.

·                  Some level of contractual and financial awareness is preferred.

·                  Excel spreadsheets, SAP, ETQ

·                  English (at least intermediate)

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:

Domestic

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R538909