Sterile Operator

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Date Published : 02 Mar 2023 | Category: Factory | Expiry Date: 09 Mar 2023 | Location: OTC Clayville | Reporting to: Shift Leader

Required Learning:

  • Grade 12 - Must have Life Science as a Grade 12 subject
  • N4- N6 Engineering Qualification (Mechanical, Electrical, mechatronics etc.)
  • Life Science post matric qualification an advantage
  • At least 1 year’ experience in pharmaceutical/Steriles or similar production operations
  • Preference will be given to Coloured, Indian and white candidates
  • Previous sterile/pharmaceutical or microbiological background an advantage
  • Fully English literate
  • Must be able to achieve a pass rate of 80% with respect to in-house sterile training requirements
  • Self-Discipline, conscientious, perseverance,
  • Integrity, honesty and responsibility.
  • Ability to work in solitude
  • Cleanliness
  • No chronic skin, hair or respiratory conditions
  • Does not fidget
  • Good eye sight

Key Outputs :

  • Conduct operating activities in the sterile manufacturing plant.
  • Execute machine setup for the sterile eye drops machines as per SOP.
  • Ensure that In-Process and Final filled product sample are taken and sent for processing.
  • Execute operating procedures on PLC driven machines.
  • Monitor and respond to the manufacturing particle monitoring system.
  • Execute environmental monitoring operations in the sterile plant.
  • Execute sterile eye drop filling machine strip down.
  • Perform material cleaning and preparation for batches.
  • Monitor and respond to alarm signals from equipment.
  • Execute cleanroom cleaning, sanitization and fumigation procedures to ensure that facility hygiene is to the required standard.
  • Participate in aseptic process validations (media fills)
  • Complete production records (logbooks, MBR etc.)
  • Participate in various quality system elements, including systems such as complaint handling, recall handling, deviation management, root cause analysis, CAPA management, change control, and quality risk management.
  • Execute material handling activities.
  • Comply with GMP requirements in the sterile plant.

Core Competencies:

  • Deciding and Initiating Action
  • Delivering Results and Meeting Customer Expectations
  • Planning and Organising
  • Coping with Pressure and Setbacks
  • Adhering to Principles and Values
  • Working with People
  • Following Instructions and Procedures
  • Adapting and Responding to Change
  • Able to stand for long periods of time with minimal movements
  • Physical fit

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