Quality Assurance Systems Lead

Job Advert Summary

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

National Bioproducts Institute NPC has a vacancy for the role of Quality Assurance(QA) Systems Lead. The successful incumbent will be required to:

Ensure excellence in the Quality Assurance departmental operations by leading technical initiatives and maintaining compliance with industry standards through:

Ensuring excellence in the Quality Assurance (QA) department and organisational compliance with cGMP, ISO13485 and regulatory requirements, through effective performance of quality management (QMS) functions by:

• Co-ordinating the annual internal, external and vendor audit programmes, through planning, executing and reporting.
• Implementation and management of systems and tools.
• Ensure that process risk assessments are planned and conducted.
• Ensure all changes at NBI are documented and processed.
• Ensure all documents and records are effectively controlled.
• The maintenance, reporting and frequent review of the various QMS systems, processes and procedures that are in keeping with the QA department objectives and industry standards.
• Identifying and reporting on quality metrics for each system at review meetings and forums.
• Implementing continuous improvement measures in the QA department.

Applications are invited from suitably qualified and experienced candidates.

Minimum Requirements

• Bachelor’s Degree in Chemical engineering, chemistry, biochemistry, biological or pharmaceutical science or related technical or scientific field.
• At least 2 years of experience with supervising/leading teams.
• A minimum of 5 years experience in the Pharmaceutical Manufacturing or Pharmaceutical Quality environment, with working knowledge of pharmaceutical facilities, equipment, laboratories and Quality Management Systems is required.
• Minimum 2 years experience as an auditor of quality systems (ISO9001, ISO13485 and/or GMP).
• Experience with ISO13485:2016 would be an advantage.

Duties and Responsibilities

Leadership and Team Management

• Direct and manage a team of Quality Assurance professionals, providing mentorship, performance management, and professional development
• Foster a quality-focused culture throughout the organisation
• Represent the QA department in cross-functional initiatives and management meetings
• Identify suitable quality metrics for the QA teams and systems, evaluate and identify areas for improvement
• Establish annual Quality Objectives and report on progress

Management of Quality Systems

Systems Applications and Products Quality Management (SAP QM) System

• Ensure Quality notifications are created correctly and put into workflows with the appropriate tasks.
• Conduct trend analysis, report on status and present information during review meetings.
• Review and improve all systems in SAP QM.
• Draft the User Requirements Specification for changes to the system and provide support in conjunction with IT before implementation.
• Provide training on effective use of systems where required.

Implement a formal procedure for each Quality System function.

• Maintain the procedure through regular review and update in accordance with regulatory requirements.
• Ensure the implemented QMS procedures are followed and provide training on procedures as required.
• Review and report on system trends. Implement continuous improvement measures.

Internal, External and Vendor Audits

• Manage the audit system by drafting an annual programme for internal, external and vendor audits.
• Ensure an effective internal GMP audit system through developing comprehensive risk based self-inspection and internal audit schedules, analysing audit trends to identify systemic quality issues and opportunities for improvement, reporting on audit outcomes and audit effectiveness checks. Escalate areas of concern or when timelines are exceeded.
• Supervise and lead GMP auditor and compliance officers to ensure optimal performance. Oversee the preparation of and review written reports by team.
• Review assessment of non-compliances with regard to quality impact and escalate as necessary based on the criticality of the situation, compliance risk, and impact to product supply.

Document Management

SAP Document Management System (DMS)

• Manage the document control system to ensure compliance with regulatory requirements and approved procedures.
• Oversee the creation, review, approval, and implementation of documentation.

Documentation Control

• Supervise the issuing and availability of all authorised copies of documents at NBI to ensure operational continuity.
• Manage the document lifecycle process from issuing, and return for storage, to archiving at an offsite storage, including retrieval if required and providing document owners with registration to approve destruction.
• Manage the QA-related documents on the NBI SharePoint.
• Drive continuous improvement of documentation processes.

Manage the Change Control System

• Oversee the change control system to ensure proper evaluation of all changes at NBI’s GMP areas are identified, controlled and managed, and associated risk assessments, impact analyses and document updates are conducted.
• Facilitate change implementation timelines and verify post-implementation effectiveness.
• Ensure execution of related batch restriction notifications related to changes.
• Review and report on change management progress and trends and propose improvements to the change control system.

Proactive Risk assessment support

• Lead the development and implementation of process risk assessments across operations using the appropriate tools.
• Review the process risk assessments, provide input and escalate/convene meetings where required.
• Ensure appropriate risk mitigation strategies are implemented and monitored.
• Maintain risk registers and oversee periodic risk reviews.

Quality Assurance General Support

• Support the QA teams/department representatives as a team member on investigations and training initiatives undertaken, to improve overall quality.
• Oversee the control of retention samples in QA by supervising the appropriate filing, storage and disposal of retention samples.
• Monitor and maintain the status of materials within the QMS to ensure compliance with GMP requirements, (e.g., quarantine, embargo), coordination with relevant departments for timely disposition, and accurate documentation in electronic and manual records.
• Oversee/coordinate the preparation of QA contributions to various quarterly and annual reports, such as the annual product quality review (APQR).
• Keep up to date with changes to regulatory guidelines and industry trends as applicable to NBI, and report on these changes regularly. Work with respective departments to align with guideline updates.
• Review QMS function documents and reports as required.
• Assist with the submission of certification requests to regulatory bodies as required.
• Participate in SHE audits and provide support for attendance to findings/investigation outcomes in QA.
• Provision of general administrative support as required.
• Participate in SHE audits and provide support for attendance to findings/investigation outcomes in QA.
• Provision of general administrative support as required.