Head of Quality - Paarl
HEAD OF QUALITY – PAARL
Wellness Solutions Industry
Salary: Attractive package on offer
Our Client is a leader in the Wellness Product manufacturing industry based in Paarl. They have an exciting vacancy for HEAD OF QUALITY that has an exception knowledge of botanicals and have a strong business accumen skill set.
The ideal candidate will have strong organization, communication, and leadership skills and a background in biopharmaceutical manufacturing and quality systems.
• Responsible for management of the company’s Quality Assurance programs for our manufacturing operations including: Deviations, CAPA, SCAR (Supplier Corrective Action Requests), Change Control, Customer Complaints, Supplier Management
• Manage Document Control functions and administer changes in document management system
• Manage incoming materials and finished product sampling and disposition in Qmuzik ERP system
• Participate in documentation reviews such as batch records, validation protocols and reports
• Manage the retain program
• Approve changes to controlled documents
• Provide QA expertise and guidance to resolve significant issues in compliance with cGMPs, in a fast-paced environment
• Recommend and implement improvements to QA procedures to assure cGMP compliance
• Perform external and internal audits
• Participate in regulatory inspections
• Identify key quality metrics, publish and monitor
• Participate in hiring, management, and development of QA personnel
• Collaborate with cross functional groups
• Notify Management of potential quality and regulatory issues that may impact product quality or regulatory compliance
• Foster a culture and environment of innovative research excellence through the development of research teams and translational research projects.
• Provide academic and administrative leadership within Afriplex by participating in the development and delivery of policy and strategy.
• Identify and pursue opportunities for multi-disciplinary internal and external collaborations and development of flagship research projects.
• Lead clinical research collaborations with key partners.
• Oversees the originating of new products in concert with customer needs and business model.
• Selects correct design concepts and fundamental technology used for new products or improvement for existing ones
• Oversees key projects, processes and performance reports, data and analysis
• Develops and implements methods and procedures for monitoring projects such as preparation of records of expenditures and research findings, progress reports, and staff conferences, in order to inform management of current status of each project.
• Negotiates contracts with consulting firms to perform research or other applicable studies or support
• Plans and formulates aspects of research and development proposals such as objective or purpose of project, applications that can be utilized from findings, costs of project, and equipment and human resource requirements
• Management experience
• Knowledge of cGMP documentation practices, cGMP compliance for pharmaceutical and medical device products, Quality principles, and industry practices
• Strong attention to detail
• Familiarity with manufacturing equipment and processes
• Experience with inhalation products is a plus
• Planning and organizational skills to handle multiple priorities effectively, resource constrains and tight timelines
• Strong verbal, written technical and interpersonal communication skills
• Ability to interact at all levels to influence outcome cross-functionally
• Ability to exercise judgment within defined practices, policies, and company objectives in order to evaluate and solve problems
• Ability to use sound analytical methods for making decisions that may impact product and cross functional success
• Ability to resolve problems ranging in scope from moderately complex to complex where analysis of situations or data requires in-depth evaluation of various factors.
• PhD in life sciences (organic chemistry) or pharmacist B. Pharm with TQM (Added advantage)
• Experience with complimentary medicines and Botanical extracts as well as knowledge of CAMs, homeopathic and herbal medicines will be advantageous.
• Excellent written and verbal communication skills.
• Ability to manage multiple and varied tasks with enthusiasm and prioritizing of workload with attention to detail.
• Computer literate with good numeracy skills. Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
• A flexible attitude with respect to work assignments and new learning.
• Self-motivated with a willingness to accept responsibility and challenges.
• A minimum of 10 years’ experience in Pharmaceutical Quality Assurance and research.
• Knowledge of the Pharmaceutical Industry and Healthcare environment
• Ability to analyse documentation and assess the relevance of process variances and reports on product quality
• Proven ability to build and develop teams.
• Proven comprehension of technical information and regulatory expectations.
• Working knowledge of South African and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
• Exhibited proficiency working within quality systems.
• Ability to lead cross-functional initiatives to completion.
• Ability to successfully communicate with representatives from all levels within the organization.