Quality Assurance - East Rand, South Africa - Unique Personnel

Unique Personnel

Verified Company

East Rand, South Africa

1 week ago

Posted by:

Thabo Mthembu

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Description

Job Number

72887

Job Type

Permanent

Job Title

Quality Assurance & Regulatory Affairs Manager

Computer Skills

ERP,ISO 9001,ISO13485,OHSAS 18001,ISO 14000,SAHPRA,MARS,MS Office,QMS,SANS

Industry

Pharmaceutical
Healthcare

City

Ekurhuleni (East Rand)

Province

Gauteng
Reporting to the Chief Financial Officer
Core Activities:
Quality Management (ISO 9001 & 13485):
Fulfil the requirements of Quality Systems Manager as per ISO 9001/13485;
Design, documentation and rollout of quality management practices in compliance with documented company policies and procedures;
Alignment of adopted company policies and processes to best practices of similar industries;
Implementation and monitoring of quality management system (QMS) through a central reporting database (Central CPAR System);
Ongoing training of staff on quality management system and company practices;
Ensure compliance to QMS through conducting regular internal reviews/audits;
Timeously address corrective actions raised, give feedback and facilitate the implementation of controls or practices to prevent reoccurrence;
Appoint and train internal ISO audit managers;
Facilitate the external audit on the ISO system and address timeously any major and/or minor nonconformances raised;
Ensure management meetings are held on a regular basis in compliance with set frequencies;
Provide a monthly risk assessment report on the effectiveness of the QMS.
Perform periodic supplier reviews (BEE, Rates, SLA's etc).
Establish the requirements for compliance with ISO 13485 in accordance with applicable frameworks (gap analysis);
Ensure compliance with the requirements of ISO 13485;
Perform regular internal audits to ensure compliance with specific ISO 13485 requirements;
Provide a monthly risk assessment report on the effectiveness of the QMS
General Business Risk:
Conduct Supplier Risk Assessments when required;
Perform customer surveys as required to establish trends. Analysis to be performed against standard company quality assessment parameters. (Alternate parameters to be recommended where necessary);
Ensure equipment used in technical is calibrated and safe for use;
Manage the process for Incident Reporting and ensure confidentiality at all times;
Manage applicable legislative requirements in terms of Labor Inspections;
Recall procedure exposure;
Knowledge of infection control procedures.
Health & Safety:
Perform the tasks and assume responsibility as Company Health and Safety Officer;
Assume full responsibility for Health and Safety Issues in the company, including First Aid, Fire and Evacuation drills. (e.g., scheduling and ensuring fire prevention devices are maintained, signage is clear and visible, fire department inspections, etc.);
Ensure compliance with applicable Health and Safety Requirements for all sites, branches (locally and abroad);
Prepare all necessary documentation and provide necessary guidance in terms of all health and safety requirements for projects and other site installations, including but not limited to site risk assessments, representative appointments, assignment of responsibility etc.
Regulatory Assurance & Compliance (all group companies, including Africa):
Identify and maintain registrations with applicable regulatory bodies e.g. South African Health Product Regulatory Authority "SAHPRA", Medical and Related Substances Act "MARS" (Products and/or Corporate)
Ensure compliance with applicable South African National Standards "SANS" regulation
Maintain necessary and applicable registers
Research and keep abreast of local legislation, industry changes, etc. (include African countries).
Liaise with Product Managers in terms of requirements for registration with Department of Radiation (manage this process), CIDB, etc.
Maintain register of products with associated GMP codes.
Ensure Compliance with WEEE Act where applicable.
Ensure Compliance with Recall and Adverse Incidents requirements (supplier & legislative).
Human Resource Activities:
Staff Training and development
Capacity Analysis
KPI Setting and monitoring (Performance Reviews)
Resource planning, capacity analysis
Promote and maintain relationships and communication with other divisional heads.
Present induction programs, and other training content.
Inherent Requirements
Required Education, experience & exposure:
Qualifications, degree or equivalent in quality assurance and regulatory affairs management.
Have a minimum of 5 years' experience in quality control and servicing within the medical equipment industry, or similar and applicable environment.
Exposure to infection control processes and practices
Exposure to multicompany, multidivisional and regional structures and consolidation thereof.
Exposure to African Activity/transactions, including multicurrency transactions.
Good knowledge of over corporate str