20 Jan '20
Group Quality Manager (Pharmaceutical and Medical Devices)

Pharmaceutical , Gauteng Centurion

- Monthly

A pharmaceutical company, based in the Centurion 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 the 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

Prioritize 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

 

Ad Visible Until: 27 January 2020
Ref: JHB000110/AG

Vacancy Type: Permanent