Senior Quality Assurance Specialist, Switzerland (f/m/d)

Job Description

For our In-Market Quality Team in Switzerland, we are looking for a Senior Quality Assurance Specialist. The role must be based in Switzerland, preferably in the region of Lucerne.

About the role:

In this role the Senior Specialist QA will act as QRP/FvP deputy, reporting to the QRP/FvP. The QRP by Swiss law is responsible for direct supervision of the operation, safety, efficacy, and quality of the medicinal products, and to ensure that the import, export, and wholesale of ready-to-use medicinal products are performed in accordance with the rules of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

Role Responsibilities:

• Individual market release of authorized pharmaceuticals in compliance with registered specifications and manufacturing according to Swiss MPLO and independent from commercial functions, based on the release documents of the QP of the manufacturer

• Local coordination and execution of recalls

• Manage representative batch release samples in line with national legislation

• Management of repackaging/re-stickering activities in coordination with regional and global Quality Organization

• Decide on the final disposition of returned, rejected, recalled or falsified products independent from commercial functions

• Develop, implement, and maintain the local Quality Management Systems (procedures)

• Ensure Quality training of personnel including assessment of training effectiveness

• Approve and review local procedures with Quality impact

• Ensure effective management of Product Quality Complaints (PQCs) including routing the PQCs and samples to the manufacturing site, and trending.

• Handling of suspect Counterfeit, Diversion or Tampering (CDT) including HA notifications

• Ensure compliant handling of Physicians Samples (e.g. distribution, storage and tracking)

• Management and review of Product Quality Reviews (PQRs)

• Deviation management, overview, tracking and trending

• Management of CAPAs, including tracking

• Ensure handling of temperature excursions during transport, warehousing, and distribution

• Ensure Change Control procedure is applied

• Oversight of validated IT-systems used in the local GxP area.

• Ensure customers and suppliers have the appropriate HA authorization to manufacture, warehouse, distribute, or purchase medicinal products

• Participate or ensure due diligence and audits to assess competence and reliability of external partner(s)

• Review and approve Quality Agreements to ensure inclusion of appropriate Quality elements

• Quality oversight of subcontractors and Third-Party Logistics provider (3PL) to ensure operations (e.g. incoming inspection of Organon products, storage, picking and distribution) complies with regulatory requirements and the conditions specified in the Dossier

• Conformity check of medical devices according to MedDO

Required Education, Experience, and Skills:

• Higher education (e.g. Master’s degree) in pharmaceutical, chemical or biological sciences

• Minimum of 3 years’ experience in Quality within Pharma industry;

• Knowledge and experience of GDP (and preferably GMP), Swiss pharmaceutical and Medical Devices regulations, as well as of EU and other international guidelines

• In-depth knowledge of Quality Management System processes

• Experience in applications such as SAP, eQMS solutions and eLearning systems is a plus

• Good Communication, interpersonal skills and fostering cross-functional collaboration.

• Problem solving and decision-making capabilities, able to apply risk management.

• Fluent in English and in German language.

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.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

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:R525168