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QA Regional Lead: Africa
Medical
Contract typePermanent
Date Posted2024-10-15
Salary
LocationMidrand, Gauteng
Date Posted2024-10-15
Salary
LocationMidrand, Gauteng
Job Specifications
To oversee assigned CMO’s portfolio and ensure all aspects of manufacturing, testing, and release for pharmaceutical products at external supplier sites comply with International and Local standards of current Good Manufacturing Practice (cGMP), current Good Distribution Practice (GDP) regulatory requirements, AQDs, and the applicable Quality Agreements.
The position serves as SPOC internally for all quality-related activities for the assigned CMOs portfolio.
The position serves as SPOC internally for all quality-related activities for the assigned CMOs portfolio.
Introduction
- Acts as Single Point of Contact / SPOC for all quality-related activities at assigned external suppliers in the region.
- Provide quality presence, risk assessment and input to technical meetings with the external suppliers and establish good working relationships.
- Co-design and execute QMS for CMOs management and implement in the related region.
- Responsible for overseeing the quality performance of the CMOs with corresponding KPI’s set.
- Provide front-line support to manage all quality-related issues.
- Responsible for coordination of all GMP and GDP related topics with the CMOs, related to operations and/or compliance.
- Communication with CMO/s and customers.
- Co-Design and execute S&OP meetings with CMOs based on defined frequencies within ESO.
- Oversee, coordinate and manage product life-cycle changes, product line extensions, or new product launches to ensure orderly and timely transitions of production flow.
- To provide timeous support to the Sales and Supply Chain Teams for batch release.
- Adhere to internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
- Manage and maintain Transport Validation requirements in accordance with GDP for all products.
- Ensure completion of all assigned Company training within the specified timelines.
- Forward all of the received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
- Any other duties assigned by Senior Management.
- B.Pharm degree
- Registered pharmacist with the South African Pharmacy Council
- Minimum of 8 years experience in a GMP-regulated environment, preferably in Quality and/or Manufacturing.
- Excellent communication skills, able to connect and quickly create relationships with external suppliers.
- Objective-driven, team-oriented and cross-functional thinking
- Management and leadership skills are essential
Should you not receive feedback within 7 days, please accept your application as unsuccessful
Apply now
To apply for the above mentioned vacancy, you will need to fill in a few details and attach an up-to-date CV.
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