Quality Assurance Specialist

5 days ago

Johannesburg, South Africa Abbott Laboratories Full time

**Position Title**: Quality Assurance and Compliance Specialist**

**Division**:Established Pharmaceuticals division**

**Location**:Johannesburg**

**DO WORK THAT MATTERS.**

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

This role is responsible for administering the affiliate Quality Management System, for the English Africa.

Ensures that all Quality Systems and Processes at the affiliate are compliant with local regulations and Abbott Quality policies and standards

Assists the Head Commercial Distribution Quality Assurance with Quality Management Review coordination and Agency Inspections/ External Audits

**RESPONSIBILITIES**:
Quality Document Management System:
Maintains the affiliate Quality Document Management System & Quality Manual.

Controls local Quality Policies and documents (QD), ensuring compliance with local regulatory requirements and cGMP.

Coordinate’s communication, distribution, review and implementation of local Quality Policies and documents.

Maintains the QD database & revision schedule.

Training related to the Quality System and GMP:
Manages GMP & QD System training for new employees

Maintains an annual / biennial training program, as required, for existing employees.

Maintains QD training matrices and training records.

Manages monthly reconciliation of employees and maintains the company Organogram

Audits Management:
Maintains the affiliate Audit schedule and coordinates the audit program

Conducts audits of Third-Party Vendors and printers as per the audit program

Participates in Audits of Distributors, Third party Manufacturers (TPMs) and Third-Party Labs (TPLs)as per the audit program

Coordinates and conducts internal audits of the affiliate’s quality systems as per the audit program

Assists Head CDQA QA during Agency Inspections and Supplier audits

Quality KPIs

Coordinates the reporting of monthly Quality Metrics for the Affiliates to Regional CDQA

Approved Supplier List Management:
Maintains an Approved Suppliers List for Third Party Vendors and printers, Distributors, TPMs and TPLs, in compliance with the One Abbott Supplier Management requirements.

Maintains the Affiliate Customer list and Bone Fides of Distributors

Product Complaints, Counterfeits, Diversions, Tampering & Theft.

Manages the product quality complaint system.

Investigates all product quality-related complaints via the appropriate quality complaint handling system, and when necessary ensures CAPA is put in place.

Ensure Counterfeits, Diversions, Tampering & Theft.are logged in the complaints system and investigated

Change Request

Initiates Change Requests

Assists Head CDQA, EAC to Liaise with action item holders for completion of outstanding actions.

Assists to closes out Change Request and provides metrics for Management Review

Exceptions, Planned Deviations & CAPA

Register Exceptions & Planned Deviations processes.

Investigate exceptions and planned deviations and ensure CAPA is put in place.

Track CAPAs until closure.

Annual Product Quality Review

Maintains the Annual Product Quality Review (PQR) Schedule in alignment with the manufacturing site PQR publication dates

Manages the local Product Quality Review for all registered products in the English Africa Cluster

**QUALIFICATIONS AND EXPERTISE**:
**Education**:
Bachelor of Science Degree or National diploma in Analytical Chemistry, or equivalent qualification or equivalent experience.

Courses in GMP, GDP and GXP and any other quality related courses / trainings.

**Experience**:
At least 2 years Quality Assurance, preferably in a pharmaceutical manufacturing / quality environment

Project Management

Comprehensive knowledge of GMP.

Knowledge of current legislation governing the quality of registered medicines & complementary medicines.

Knowledge of other legal requirements impacting the quality and regulatory environment, e.g. GMP, Guidelines for Amendment etc.

Knowledge of the Abbott organization, policies and procedures

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