Operations and Quality Assistant

Job Advert: Operations & Quality Assistant

Company: Novita Biotechnology (Pty) Ltd
Location: Constantia, Cape Town, South Africa (On site)
Department: Operations
Reports To: Operations / Quality Manager

Company Overview:

Novita Biotechnology is an innovative company within the biotechnology industry, specialising in the development and distribution of medical devices. Our mission is to improve patient outcomes through cutting-edge technology and exceptional product quality. We are committed to maintaining the highest standards of regulatory compliance, including SAHPRA registration and ISO 13485 accreditation.

Position Overview:

The Operations & Quality Assistant supports the daily operations of Novita Biotechnology by assisting with administrative tasks, maintaining documentation/records, warehousing, stock control, packaging/labelling, invoicing, handling customer enquiries, logistics, and ensuring quality with compliance with regulatory standards. This role is essential for maintaining smooth and efficient operational processes within the company. Training will be provided for a suitable candidate who has the right mindset and is open to learning.

Key Responsibilities:

1. Administrative Support:
- Assist with day-to-day administrative tasks such as scheduling, customer invoicing, customer
liaison, and correspondence.
- Maintain and organise operational records and documents.
- Prepare and distribute reports, meeting minutes, and other documents as required.

2. Inventory / Supply Chain Management / Warehousing / Manufacturing:
- Monitor inventory/stock levels and assist in the procurement of supplies and materials.
- Co-ordinate with suppliers and vendors to ensure timely delivery of goods.
- Track and report on inventory usage and stock levels.
- Packaging and assembly of products/medical devices ready for sale.

3. Operational Efficiency:
- Support the Operations Manager in identifying areas for process improvement.
- Assist in the implementation of improved/new processes.
- Monitor and report on key performance related to operational efficiency.

4. Logistics / Courier / Deliveries:
- Ensure timely delivery of products to customers, both locally and internationally, making use
of courier companies and hand deliveries.
- Track and follow-up on delivery statuses of parcels.

5. Quality Assurance / Regulatory Compliance Support:
- Assist in maintaining quality control processes and traceability of raw materials and batch
numbers.
- Help document and track quality issues and corrective actions.
- Support the implementation of continuous improvement initiatives to enhance product
quality.
- Ensure that all operations comply with SAHPRA regulations and ISO 13485 standards (training
will be provided).
- Assist in the preparation and organisation of documentation for audits and inspections.
- Maintain up-to-date knowledge of regulatory requirements and support implementation of
necessary changes (training will be provided).

Key Performance Indicators (KPIs):

1. Administrative Efficiency:
- Timeliness of Task Completion: Percentage of administrative tasks completed on time.
- Accuracy and timeliness of customer invoices, and dispatch of products.
- Accuracy of Documentation: Accuracy and completeness of maintained records.
- Report Preparation: Quality and timeliness of reports and documents prepared.

2. Inventory / Supply Chain Management / Warehousing / Manufacturing:
- Inventory Accuracy: Accuracy of inventory records and stock levels.
- Supply Chain Efficiency: Timeliness and reliability of supplier deliveries.
- Stockout Incidents: Number of stockout incidents (packaged for sale and ready for packaging)
and resolution time.
- Goods received, captured, and stored correctly.

3. Operational Efficiency:
- Process Improvement Participation: Involvement in process improvement initiatives.
- Efficiency Metrics: Tracking and reporting on operational efficiency metrics.
- Support to Operations Manager: Level of support provided in enhancing operational
processes.

4. Logistics / Courier / Deliveries:
- Number of deliveries on time versus late (related to customer complaints).
- Number of avoidable courier / delivery mix-ups.

5. Quality Assurance / Regulatory Compliance:
- Audit Preparedness: Readiness for internal and external audits with minimal findings.
- Training Completion: Percentage of required regulatory training completed on time.
- Documentation Accuracy: Accuracy and timeliness of regulatory documentation.
- Quality Issue Tracking: Timeliness and accuracy in documenting quality issues.
- Corrective Actions: Effectiveness and timeliness of corrective actions taken.
- Support in Quality Initiatives: Participation in and contribution to quality improvement
projects.

Qualifications & Attributes:

Required:
- Matric with at least full Mathematics.
- Live within 10km radius of Head Office in Constantia, Cape Town (no relocations).
- Valid driver’s license.
- Reliable transport.
- Meticulous attention to detail.
- Strong organisational and time-management skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced and dynamic start-up environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), with the adaptability to learn
new software applications.
- A commitment to co-creating a positive work culture.

Advantageous:
- Diploma or degree in Medical Sciences, Business Administration, Operations,
Supply Chain, and/or Quality Assurance, or a related field, and/or equivalent
experience.
- 1 years of experience in an administrative or operational support role, preferably
in the medical device or biotechnology industry, not essential.
- Knowledge of SAHPRA regulations and ISO 13485 standards would be advantageous, but not
essential as necessary training will be provided.

Application Process:

Interested candidates should submit their concise CV and a cover letter outlining their qualifications, experience, and suitability for the role by 28th October 2024 (or sooner if a suitable candidate is identified/numerous applications are received). Position available immediately.

Novita Biotechnology (Pty) Ltd is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.