Group Quality Manager - Centurion Verfied

Salary Negotiable Centurion, Gauteng Centurion, Gauteng more than 14 days ago 13-12-2019 8:28:10 AM
07-02-2020 8:28:10 AM
A pharmaceutical company, based in the area, has a vacancy for a Group Quality Manager for their Pharmaceutical and Medical Device divisions. This position will be reporting to the General Manager, with four subordinates.

Responsibilities:
Support Responsible Pharmacists with responsibility for 100 % compliance of the business in terms of GMP and to comply with all SAPC, SAHPRA, ISO 13485 and DOH requirements
Responsible for all Group Quality Assurance Functions and oversee Product Releases for all operational companies
Assist and support Responsible Pharmacists (Pharma) and Authorised Representatives (Medical Devices) to ensure compliance in terms of cGMP (Pharma and Medical Devices), ISO 13485 and international standards
Assist and support Responsible Pharmacists to ensure compliance with all SAPC, SAHPRA and DOH requirements
Assist and support the Authorised Representatives (Medical Devices) and the QA/RA Manager – Medical Devices to ensure continuous improvement and compliance with all SHAPRA requirements.
Oversee final Product Releases and driving timeous releases by effective communication between Logistics, Commercial, Distributor and Release Laboratory
Post-importation testing readiness: Samples to 3rd party; Reference standard maintenance; Current Final Product Release Specs and Methods at laboratory
Annual quality planning is done and executed accordingly
QA related Risk assessments if and when necessary
Responsible for Change Control approvals with QA impact
Deviations and CAPA’s for Quality issues if relevant
Maintaining a documentation system according to cGM, across all Pharmaceutical and Medical Device business units
Continues improvement of Quality Management systems within the different business units
Control and management of Quality management systems across all divisions
Assist and support with ISO 13485 implementation within the Medical Device companies
Final approval of all external supplier audits or Regulatory/Health Authority inspections responses and associated CAPA-Plans
Project lead for all identified quality-related projects and changes
Coordinate, review and approve 3rd Party Technical Quality Agreements
Final approval of Supplier / Service provider assessments and qualification
New Launches: Assist with Analytical Method Transfer process
Control and Assist with technical complaints, customer returns and rejections across all divisions
Conducting timeous self-inspections and internal audits across all divisions
Evaluation and completion of Annual Product Reviews (including follow-up stability data, Batch manufacturing records)
Audit Schedule maintenance and Vendor Audits (Manufacturer, Packers, 3rd party Distributor and Laboratories)
Assist with approval of printed packaging material
Monthly Management Quality reports and feedback on all applicable business units
Coordinating an annual Quality meeting and preparing a Quality report and reviewing annual quality reports from the business units respectively
Ensuring continuous training on cGMP (Pharma and Medical devices) and ISO 13485 (where applicable)
Overseeing all training matrixes and schedules for each business unit and ensuring training on documents and procedures are continuously completed
Support and assist 3rd party Distributor and Warehouse with quality functions and implementation of procedures

Requirements
B-Pharm or BSc or similar qualification
At least five (5) years’ quality management experience in the Pharmaceutical and Medical Device Industry
Pharmaceutical and Medical Device cGMP knowledge and experience
Preferably GDP and ISO 13485: Medical Device experience
Valid driver’s license
Must be able to work outside office hours when required or requested to do so.
Detail orientated and organized
Analytical and Interpretation
Prioritise workload to tight deadlines
Cross functional ability
Must be available after hours via cell phone in case of emergencies only
Must be able to travel if required

Recruiter: H2R Africa