Associate Director Quality Assurance, Qrp

3 days ago

Johannesburg, South Africa Organon Full time

**Job description**

Associate Director Quality Assurance and Quality Responsible Pharmacist

**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

**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 In-Market-Quality Cluster Lead.
- The role is also responsible to support the fulfillment of the country legal requirements as Responsible Pharmacist as per regulation 25(3) of the Pharmacy Act and the Medicines and Related Substances Act, 101 of 1965.
- The Responsible Pharmacist is responsible to support compliance of the company to the Pharmacy Act, and Medicines and Related Substances Act, 101 of 1965.

**Organizational Integration**
- Solid line report to the In-Market-Quality Cluster Lead
- Dotted-Line to the Managing Director Organon South Africa
- 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**:

- Ensure regulations pertaining to Quality and Compliance for importation, batch release and distribution of the products on the markets are fulfilled
- Responsible for implementation, maintenance, and further development of the local Quality Management System in compliance with GMP, GDP, South African Law and company´s policies
- Ensure the preparation, review and/or approval of GMP/GDP relevant documents (e.g. SOPs, Product Quality Reviews, training documentation
- Release of commercial products for the South African and other Sub-Saharan markets independent from commercial functions or the management in compliance with local regulations
- Ensure the effective and compliant handling and control of Deviation, CAPA, Changes Controls, Outsources operations, product samples and customer qualification.
- Decide on the final disposition of returned, rejected, recalled, or falsified products independent from commercial functions or the management
- Ensure the qualification and oversight of GMP/GDP relevant partners
- Responsible for the coordination and/or performance of the internal audits as well as for the monitoring of completion of effective CAPAs in time.
- Responsible for Health Authority (HA) interactions and notifications regarding Quality issues
- Responsible for the preparation and host of local Health Authorities inspections and Global Audits
- Information and interaction with local business and regional Quality Management and relevant stakeholders
- Ensure Quality perspective is brought into local business initiatives with Quality impact
- Local coordination and execution of recalls
- Primary country contact for Organon Global Quality

**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**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R512243

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