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Quality Assurance Specialist and Deputy Responsible

5 months ago

Johannesburg, South Africa Organon Full time

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it

Organon South Africa, a wholly owned subsidiary of Organon & Co. Inc. Organon is a brand - new independent company and publicly traded company that aspires to become the world’s leading Women’s Health Company with a global portfolio that will include biosimilars and a broad array of medicines spanning important therapeutic categories. With a footprint and bringing lifesaving medicines to more than 140 international countries.

We are a Women’s Health Company that believes in a better and healthier every day for every woman It is important as our vision states that we as Organon South Africa, contributes to woman equality, providing medicines and access to women, creating opportunities and educating our woman as we contribute towards the upliftment within our communities and our economy.

**_ Organon Values_**
- **_ Be Real _**- We will be authentic and transparent
- **_ We All Belong _**- We will see diversity as critical to all we do, making sure everyone has a voice and feels a sense of belonging
- **_ Bring your Fire _**- We will maintain passion for our purpose and what we do.
- **_ Own It _**- We will drive accountability and empowerment with high integrity and ethical standards
- **_ Rise Together _**:

- We will collaborate and succeed as a team
- ** Keep Moving **- We will be entrepreneurial and resilient, lean into challenges and embrace change

**Job description**

Quality Assurance Specialist and Deputy Responsible Pharmacist

**Position Overview**

Key purpose and basic responsibilities of the position
- The role is responsible for supporting Country In-Market-Quality and will report directly to the Responsible Pharmacist.
- The role is also responsible to support the fulfillment of the country legal requirements as Deputy Responsible Pharmacist as per regulation 25(3) of the Pharmacy Act and the Medicines and Related Substances Act, 101 of 1965.
- Deputy Responsible Pharmacist is responsible to support compliance of the company to the Pharmacy Act, and Medicines and Related Substances Act, 101 of 1965.
- Will be designated as a Responsible Pharmacist in the absences of the Responsible Pharmacist.

**Main Responsibilities**
- support the control of manufacturing or distribution of medicines, scheduled substances or medical devices in terms of the Medicines Act, 1965
- Responsible for the final product release to the South African and African market
- Support the implementation, maintenance, and further development of the local Quality Management Systems
- Support internal audits and HA inspections at the local office
- Support the implementation of Good Documentation Practice, Good Manufacturing Practices, Good Distribution Practices, and regulatory requirements
- Support the Documentation and Training Management Systems
- Support the effective management of Product Quality Complaints (PQCs)
- Support the effective handling of suspect Counterfeit, Diversion or Tampering (CDT)
- Support the management and review of Product Quality Reviews (PQRs)
- Effective handling and control of Deviation, CAPA, Changes Controls, Outsources operations, product samples and customer and supplier qualification
- Support activities to ensure implementation of ISO 13485:2016 requirements for QMS and other local legislative requirements for medical devices
- Liaise with third party logistics provider, Organon manufacturing’s site and EQA for topics relating to compliance and product quality
- In collaboration with the Quality Lead ensure continuous improvement of the In-Market Quality department and provide support with quality projects at local, regional or global level as required and promote the quality culture

**Organizational Integration**
- Solid line report to the Responsible Pharmacist
- Must collaborate with all Organon employees in country and above market

**Qualification & Experience - Knowledge and Skills requirements**
- Minimum of 1- 3 years’ experience derived from pharmaceutical quality environment
- Bachelor of Pharmacy Degree and must be a Registered Pharmacist with SAPC
- Knowledge of pharmaceutical Good Manuf