QC Administrator at The Biovac Institute

Job Purpose

• Responsible for QC Senior Administrative activities to ensure product quality including but not limited to:
• Support to QC activities to ensure product quality.
• Maintaining laboratory operations at cGMP, GLP standards to ensure quality, safety and regulatory compliance.
• Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovativesolutions.
• Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.
• Responsible to ensure that the QC department and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
• Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Key Duties & Responsibilities

Administrative Activities:

• Assist with day-to-day laboratory operation requirements.
• Sample reception, test allocation and sample distribution to analysts.
• Preparing documents and preparation of work packages for analysts.
• Follow up on outstanding results to ensure that the laboratory meet turnaround times.
• Maintenance of sample reception logbooks.
• Stock control and processing of order requests received from QC staff members and ordering via SAP.
• Procurement of items as well as collection and receipt of stock.
• Following up of outstanding orders.
• General administration and duties which include compiling laboratory reports, sending out results, archiving of results, scanning, and filing of results and ordering of stationary.
• Ensure timely and effective communication.

Quality Management

• Building own cGMP knowledge and compliance
• Participate in achieving the company’s quality objectives.
• Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Ensuring audit readiness within own role through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs are handled effectively
• Advocate continuous improvement

Technical Competencies required to perform this aspect of the role:

• cGMP knowledge
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting
• Computer Literacy
• Standard Operating Procedures
• Quality management systems

Generic Competencies required to perform this aspect of the role:

• Planning, organising, execution, and monitoring
• Creative problem-solving skills
• Stakeholder management
• Action and results oriented
• Assertive and resilient
• Ability to multi-task
• Influencing skills
• Proactive
• Clear, timely and effective communication skills both verbally and in writing.

Experience & industry accreditation/ knowledge

Required:

• At least 1 years’ experience within the pharmaceutical/ vaccine manufacturing / quality control or similar position
• Experience in quality management systems within a cGMP facility

Preferred:

• Knowledge of Pharmaceutical related legislation
• Experience in managing databases
• Previous participation in quality audits
• Experience in aseptic (sterile) manufacturing

Qualifications

Required:

• Matric / Grade 12 or equivalent (recognition for prior learning and practical experience)

Recognition is given to Prior Learning and practical experience.

Other Requirements

• Own reliable transport