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MCC USP Specialist

Job Code:

About The Job

Perform fermentation processes in mammalian cell culture area of RM-BG and XPand C, and all related tasks ensuring successful fermentation runs to achieve the company’s goals.

Reporting To

MCC USP Section head

Department

Biotechnology Production

Benefits

Medical Insurance - Social Insurance - Life Insurance - Profit Share - Meal - Transportation

Responsibilities

  • Strongly obey all GMP rules related to the field of employment.
  • Operate production equipment necessary for production process in MCC fermentation areas
  • perform mammalian fermentation processes according to production plan
  • supervise the technicians during the production process
  • and support continuously analyzing the production process aiming at process understanding and improvement
  • acquire basic knowledge in mammalian downstream process to support DSP when needed.
  • Follow up maintenance of production equipment as per defined plan.
  • Receive and keep documents (SOPs
  • validation protocol
  • change control
  • etc.)
  • issue new SOPs and revise approved SOPs according to revision plan according to instructions.
  • Notify timely supervisor and QA about all incidents
  • participate in investigation and assessment of incidents
  • deviations and changes
  • perform root cause analysis and contribute to SMART corrective and preventive actions for audit findings
  • implement CAPA
  • additional controls
  • change control actions
  • annual report actions and management review actions according to instructions.
  • Participate in process and cleaning validation as defined in relevant protocol
  • participate in equipment internal calibration according to instructions.
  • Issue materials and tools dispensing order needed for the production process and follow up relevant stocks
  • Support supplier qualification for raw materials and consumables used in production process.
  • Contribute to quality risk management projects
  • support continuous process improvements
  • report and support assessing environmental hazard aspects and impacts
  • report and support assessing health and safety risk assessment.
  • Contribute to ramping up and establishing production in XPand C.
  • Strongly cooperate with other departments (for instance DSP
  • QA
  • QC
  • warehouse) aiming at smooth and efficient production and process flow.
  • Perform any additional tasks as requested related to the field of employment.

Requirements

  • Experience: 0-3
  • Education: Bachelor’s degree in sciences or Pharmaceutical Science.
  • Fluent in English Language.
  • Computer literate
  • Self-organizing skills.
  • Communication skills to all levels of staff.
  • Scientific searching skills.
  • Analytical skills with attention to details.
  • Flexibility according to the needs of the processes.

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Office Address

El-Bardissi St., 2T Takseem Asmaa Fahmy St., Heliopolis,
Cairo - Egypt.
Phone:(+202) 2414-3170/1/2/3/4/5
Fax:(+202) 2414-3179