Cheryldene Olivia Morris

• Implement the quality policy and ensure compliance to quality objectives as stated in the quality policy
• Periodically review quality systems for improved efficiencies and continuously improve various processes and procedures as per guidelines/ regulations
• Schedule quality compliance resources and perform strategic planning of quality management projects to meet business requirements and continued compliance
• Setup and maintain key performance indicators & quality metrics on a monthly & quarterly basis; host the monthly quality management review meetings
• Authorize the QMuzik release of batches manufactured and packaged at Afriplex and third party contract manufacturer as release by the Responsible Pharmacist to the market as per current SAHPRA regulations

· Write, review or approve various cGMP documentation including SMF, policies, standard operating procedures, work instructions, analytical validated methods, specifications, stability protocols & results for ongoing stability programs Oversee the quality management systems and ensure that QMS elements is in a State of control: .

· Perform duties to ensure operational compliance related to:

o Management of Quality Systems together with continuous improvement if the system.

o Recalls or stock recovery.

o Regulatory compliance.

o Self-Inspection (Internal Audit)

o External audits/GMP and GDP compliance.

o Management of regulatory audits and inspections.

o Management of controlled documents for example SOP’s (Standard Operating Procedures) and master documentation.

o Qualification and Validation protocols and reports approval (equipment, process, cleaning, computerized systems, utilities, environmental quality systems.

o Management of sub-contractors.

o Management and monitoring of distribution centres.

o Complaint investigation and product recall coordination.

o Quality agreement evaluation and approval.

o Annual Product Review (APR) for pharmaceutical product (i.e drug product) and for finished products of the Chemistry organisation (API’s and intermediates).

o Management of Change Control evaluation.

o Deviation and failure investigations.

o Batch rework/reprocessing approval.

o Quarantine system.

o Training programs for example GMP and GDP.

o Supplier or vendor audits, qualification and approval.

o Master documentation review and approval.

o Product or batch documentation review and approval.

o Specification approval.

o Quality Steering Committee coordination

o Quality communications and regulatory awareness

o Technology transfer approval

o Customer country interface for label text control

o Storage and distribution systems

o Implementation of Quality policies and procedures

o Key Performance Indicator (KPI) reporting

o Capital investment and project recommendations, assessments and review for all quality relevant matters.

o Disposition of returned goods

o Record retention and archives

o Annual Product Review (APR) data compilation

o Document Control management

o Quality Control Out of Specifications results

o Risk Management System

o Validation System

o Product Quality Reviews

Management of dedicated QA personnel and ensure annually objectives are set and approved for personnel.

• Internal Auditing, SABS Year 20215

• FSSC 22000, SABS, 2015

• Root Cause Analysis, SABS, 2014

• Supervisory Course, SABS, 2014

• Hygiene and Awareness Training, Swift, 2007