Aseptic Technician - Pinetown, South Africa - NBISA Recruitment

NBISA Recruitment
NBISA Recruitment
Verified Company
Pinetown, South Africa

1 week ago

Thabo Mthembu

Posted by:

Thabo Mthembu

beBee Recruiter
Description

Job Advert Summary:


  • To assist with the production of sterilized products into bottles, vials, and ampoules according to specifications and GMP compliance.
  • To process final product till inspection as per Standard Operating Procedures and Good Manufacturing Practices.

Minimum Requirements:


  • Grade 12 with minimum D marks in English and minimum D marks in Maths, Science, Biology, or EMS.
  • 12 years experience in a pharmaceutical, chemical, biotechnology, food manufacturing, or laboratory environment.

Duties and Responsibilities:


Production of final filled products

  • Preparation of equipment, machines, and components by cleaning and sterilising as required.
  • Assembly and disassembly of machines, equipment, and product transfer set to ensure product integrity.
  • Operation and monitoring of all required machines and equipment0
  • Capping and coding of filled units
  • Loading and offloading of the dehydrogenation oven, autoclave, freeze dryer, and pasteuriser as per SOP.
  • Cleaning of work machinery and work areas as per SOP.
  • Work in the clean room and follows aseptic techniques.

Sampling and environmental monitoring

  • Take required samples for QC, QA, and microbiology testing as required.
  • Perform environmental and personnel monitoring as per SOPs.
  • Ensure correct labelling of samples and product samples and transfer to respective departments.

Completion of batch records and auxiliary documentation

  • Completes batch records timeously as required by protocols and SOPs.
  • Completes log books and registers for traceability and process status records.

Maintain Equipment

  • Monitor equipment performance
  • Works with team members to conduct firstline maintenance of equipment
  • Reports incidents and machine related problems to the section head
  • Assist with the calibration and validation of equipment and processes by preparing components and equipment as required

Comply with Good Manufacturing Procedures

  • Works with team members to execute SOPs and protocols to prepare, fill, freeze dry, cap, and code ampoules, vials and bottles.
  • Follow the gowning procedure as per SOPs and GMP requirements.
  • Use appropriate packaging and ensure required conditions for the appropriate storage of inprocess materials and products.
  • Dispose of waste products according to SOP's.
  • Follows the behavioural requirements for working in clean rooms.
  • Participates in audits of manufacturing areas.
  • Works with team members to assess processes and recommend methods for improving quality and efficiency.
  • Ensure the manufacturing area is clean and tidy.
  • Attend training courses as required.

Comply with the OHS act

  • Work in a safe manner under the indirect supervision of team members.
  • Wear appropriate PPE.
  • Act as Safety Rep, Evacuation Team Leader, or First-Aider as required.
  • Reports any identified risks, hazards, and incidents.

Core Competencies

  • Managing Relationships
  • Personal Leadership
  • Business Impact
  • Leading and Influencing Others
  • Attention to detail
  • Ability to work individually and in a team
  • Understanding of sterile manufacturing
More jobs from NBISA Recruitment
See all jobs of NBISA Recruitment