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Senior Validation Specialist - Monufya

Atco Pharma For Pharmaceutical Industries
Quweisna, Monufya
Posted 6 years ago
25Applicants for1 open position
  • 22Viewed
  • 0In Consideration
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Job Details

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Job Description

JOB PURPOSE:

  • Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols.
  • Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by GMP as applicable in the pharmaceutical industry.
  • Coordinates validation related activities in regards to equipment and processes being deployed in GMP environments.

MAJOR RESPONSIBILITIES:

  • Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
  • Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products
  • Develop and execute cleaning validation/verification protocols for all commercial manufacturing, processing, and packaging equipment.
  • Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
  • Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
  • Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid.
  • Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
  • Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
  • Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.
  • Planning and execution of the calibration master plan and Validation Master Plan.
  • Responsible for compliance with quality integrated system for quality, environment, health and safety in relation with his job and duties.
  • Perform other related duties as assigned to meet departmental and Company objectives.

Job Requirements

  • Pharmacist or Chemist.
  • Languages: Good command of English.
  • Ideal experience: 4-8 years in a similar position.
  • Proven experience in pharmaceutical industry.

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JobsR&D/ScienceSenior Validation Specialist - Monufya