Quality Assurance Specialist and Deputy Responsible

**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 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.

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

**Major Activities**
- 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.

**Country Quality Management Responsibilities**:

- Support the development, implementation, and maintenance 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.

**QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS**:

- Minimum of 5 years’ experience derived from pharmaceutical quality environment
- Bachelor of Pharmacy Degree and must be a Registered Pharmacist with SAPC
- Knowledge of pharmaceutical Good Manufacturing Practices, Good Distribution Practices, and regulatory requirements
- Previous Working knowledge of SAP desired
- Working knowledge of Microsoft apps
- Attention to detail and problem-solving skills.
- Able to deal with situations requiring interpretative and evaluative thinking.
- Good oral and written communication essential.
- Flexibility and willingness to seek opportunities for continuous improvement.
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
- Ability to work independently with limited supervision
- Ability to build relationships and influence across disciplines and all levels

**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.**

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion. At Organon, we all belong. We embrace diversity and give it a voice.

Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.

**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**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
Yes

**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R509015