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QA - Senior Validation Specialis...

Pharco Corporation
Ameria, Alexandria
Pharco Corporation logo

QA - Senior Validation Specialist

Ameria, Alexandriaposted 1 month ago

Job Details

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Job Description

  • Plan, review, and execute qualification and validation activities, including equipment, utilities, facilities, processes, cleaning, and computerized systems.

  • Prepare and review validation protocols, reports, risk assessments, and related documentation.

  • Ensure validation activities comply with cGMP, regulatory guidelines, and approved procedures.

  • Review validation deviations, investigations, and CAPAs and ensure timely closure.

  • Coordinate with Production, Engineering, QC, IT, and other functions to ensure effective execution of validation activities.

  • Support regulatory and internal audits related to validation and qualification.

  • Monitor validation status and ensure timely completion of the validation plan.

  • Provide technical guidance to junior team members and support continuous improvement initiatives.

Job Requirements

  • Bachelor's degree in Pharmacy, Science or a related field.

  • 4–7 years of relevant experience in QA Validation/Qualification within the pharmaceutical industry.

  • Strong knowledge of GMP and validation principles.

  • Hands-on experience in equipment, process, cleaning, utilities, and/or computerized system validation.

  • Good knowledge of risk assessment and validation documentation.

  • Strong analytical, problem-solving, communication, and organizational skills.

  • Good command of English.

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