Senior Quality Assurance Manager (Johannesburg)

 

Recruiter:

Career Circuit

Job Ref:

Senior Quality Assur..

Date posted:

Tuesday, March 29, 2022

Location:

Johannesburg, South Africa

Salary:

Market Related


SUMMARY:
Senior Quality Assurance Manager (Johannesburg)

JOB DESCRIPTION:

Qualifications:

vA Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/ scientific area.
v5+ years’ experience in Quality Assurance, Quality Oversight or Relevant Experience.
vMin 2 years Management experience.
vKnowledge and familiarity with product, process, and both internal and external customer requirements and regulations.
vKnowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
vStrong influencing, motivational, interpersonal and relationship building skills with staff and at all levels.
vAbility to make operational and business decisions with minimal direction.
vExcellent written and oral communication skills & proficiency in English.
vAbility to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
vNegotiation skills, effective collaboration, and ability to anticipate needs and requirements, managing matrix teams.

Responsibilities and Duties:

vResponsible for the integration and support of quality regulations: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
vResponsible for the management and oversight of team (QA & QC) including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.
vEstablish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
vLead and oversee support activities related to product actions in the affiliate.
vAssure key metrics are being monitored & met to ensure compliance and to drive continuous improvement incl review of procedures & process to identify areas of opportunity.
vPartner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
vProvide GxP Quality Systems support and training to affiliate.
vSupervise execution of standard policies and processes including but not limited to Management Review, Metrics and Reporting, Supplier Controls, Risk Management, CAPA, Product Complaints, Product Action, Product Quality Review and Audits, Lab controls.
vPerform assessments to determine compliance to processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
vQuality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.
vProvide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
vRepresent affiliate QA in regional, global, and cross functional teams, projects and programs, as appropriate.
v

 

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