Job Description

A global pharmaceutical company has a 6 month contract position for a Quality Assurance Specialist.

Job Purpose:
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 countryxe2x80x99s 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 absence of the Responsible Pharmacist.

Organizational Integration:

• Solid line report to the Responsible Pharmacist
• Must collaborate with all employees in and above the 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 markets.

Country Quality Management Responsibilities:

• Support the development, implementation, and maintenance of the local Quality Management Systems
• Applying Quality Risk Management (QRM) principles
• 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 and Skills required:

• Minimum of 3 yearsxe2x80x99 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 is 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

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

MNA Recruitment