Quality Assurance Manager - Science

SUMMARY:
SM2 Talent Solutions specialize in sourcing experienced professionals across all demographics and industries from entry level to executive leadership, on temporary, or temporary with the view to assessing suitability for permanent basis.

POSITION INFO:

Location: Midrand, Johannesburg

Responsibilities:

• Compliance to EU-GMP
• Ensure Induction and Training of new and existing employees
• Handling of Product Recalls
• Internal and External Audits
• Implementation and maintenance of Quality Management System
• Ensuring compliance of Department of Health, SAHPRA, GMP, GACP and GDP/GWP.
• Approve and verify the implementation of defined systems, standards and procedures.
• Review cultivation and laboratory testing records before releasing any finished product.
• Ensure compliance of any change in Quality Control procedures.
• Ensure the induction and training of employees.
• Ensure compliance of GDP/GWP /GMP and GACP through systematic audits.
• Carry out process controls, including in-process checks, inspections, and batch clearances.
• Inspection of packaged stock before release.
• Investigate complaints, deviations, quality incidents, and non-conformances.
• Handling of regulatory inspections at the site.
• Handling of product recalls and investigate operational deficiencies.
• Ensure the implementation of revised cultivation standards, specifications, and procedures.
• Ensure the implementation of pest and vermin controls as per defined schedules.
• Review product stability reports.
• Review batch manufacturing records; verify reconciliation of batch inputs, batch yields and final release of products.
• Document control.
• Ensure GACP and training to all cultivation and In-house staff.
• Ensure proper secure storage and retrievability of records.
• Develop and review Quality Policy and Standards.
• Vendor assessment and approval.
• Support for validation activities.
• Internal Audits and self-inspection.
• Review and approval of master validation program, including equipment, processes, facilities, and analytical methodology.
• Investigate out-of-specification results or failure in cultivation techniques.
• On a periodical basis, review and upgrade quality systems as per the latest regulatory requirements

 Education:

• Degree in a Science Discipline (Chemistry, Microbiology, Pharmacy, Food Technology)
• At least 5 years experience in the Pharmaceutical or Cannabis industries
• Qualification as Quality Management Systems Lead Auditor

Skills and attributes:

• Advanced Excel skills
• Leading & Supervising
• Adhering to Principles & Values
• Presenting and Communicating information
• Writing and reporting
• Delivering results and meeting customer expectations
• Coping with pressure and setbacks
• Reliable
• Work without supervision
• Good English writing skills
• Good time management

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