Quality Assurance Specialist

SUMMARY:
To provide leadership and governance of laboratory quality systems by embedding and optimizing cGMP requirements, SAHPRA regulations, GLP and PIC/S guidelines, and ISO / IEC 17025 accreditation standards. Drive operational excellence and technical quality assurance initiatives that ensure compliant , efficient and effective laboratory service delivery aligned with clients requirements.
 
To lead, govern and optimise Laboratory Services quality management systems, current Good Manufacturing Practices (cGMP) requirements and regulation, Good Laboratory Practices (GLP), PICs guidelines, accreditation compliance, laboratory operational excellence and technical quality assurance initiatives to ensure effective, compliant and efficient laboratory service delivery in line with relevant regulations regulations and client requirements.

POSITION INFO:
REQUIRED
NQF LEVEL
Advanced Diploma or B-degree in quality
management, Laboratory Science, Chemistry
or Analytical Chemistry, related scientific / technical field

Training or certification in ISO/IEC 17025,
cGMP/PICs/WHO guidelines, Quality Management Systems or Laboratory Quality Assurance will be advantageous



REQUIRED
LEVEL: Operational Level, Supervisory Level,
Managerial Level, Senior Managerial Level, Executive
Level
8 years' relevant experience within a GMP
laboratory, quality assurance or laboratory
quality management environment
Operational Level
Experience in pharmaceutical laboratory
operations, testing processes and quality
assurance systems
Operational Level
Specialist experience in , GMP, SAHPRA
regulations, ISO/IEC 17025 Quality Management Systems and SANAS
accreditation requirements

Operational Level
Exposure to laboratory equipment
calibration, verification and maintenance processes, management of out of
specification and out of trends and corrective actions.

REQUIRED
LEVEL: Entry Level, Intermediate Level, Advanced
Level, Expert Level
Relevant Legislation and regulatory frameworks (SAHPRA and SANAS)
Advanced
Risk Management Practices and Principles
Advanced
Quality Management Systems and principles
Advanced
Computer Literacy
Intermediate
Laboratory operations and testing processes
Advanced
Project management
Advanced


REQUIRED
DESCRIPTION


Communication
Expresses and articulates key elements of ideas or concepts (both written and verbal) in a logical, descriptive, and comprehensible manner.
Anticipates reactions and responds appropriately. Probes and listens for information from others,
without interrupting or judging, to understand underlying
issues.

Planning and Organising
Frequently initiates and pursues professional relationships. Works well with others in achieving goals and building productive relationships

Results Orientation
Personally, does what is required to complete the work. Demonstrates persistence in the face of setbacks. Consistently delivers high quality results on time.

Building Relationships
Initiates professional contact outside of work team, when required by job role. Maintains relationship with internal and external contacts


Customer Focus
Thoroughly understands the customer's business environment, practices, and core processes.
Networks with relevant decision makers at appropriate intervals.


Professional and Technical Depth and Credibility
Demonstrates a working, conceptual knowledge of a narrow professional, technical/specialist, or product area. Applies knowledge for basic problem solving in typical or standard situations. Makes effort to acquire further relevant knowledge. Ability
to read schematic drawings.

Quality Focused
Follows established procedures reliably, and delivers work to defined standards of quality. Insists on thoroughness, timeliness, and accuracy of
output.
Teamwork
Demonstrates a willingness to put team needs
before those of self, and contributes to team decision making.

Personal Drive
Accepts responsibility for identifying new and
challenging personal development needs. Constantly makes self-assessments for personal development. Is self-motivated and a self-starter.

Business and Technical Mastery
Demonstrates, uses, and shares a basic
understanding of industry core processes and practices for developing industry-specific products/solutions / standards. Strives to acquire additional relevant industry knowledge.
Problem Solving
Identifies the critical elements of a problem and alternative ways of resolving it. Seeks help when
necessary.