Quality Assurance Specialist / Pharma

MPIS - Dar Alsalam, Cairo

116
Applicants for
1 open position
22
Seen
Experience Needed:
More than 2 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Confidential
Languages:
Arabic, English
Vacancies:
1 open position
Travel Frequency:
Minimal travel
About the Job

Reporting to the Quality Assurance Mananer , Quality Assurance Specialist will be responsible for maintaining quality assurance systems including investigations, deviations, and corrective and preventative actions. This individual will also be responsible for batch record review and approval, disposition of drug product, facilitate vendor management processes, and review documents needed to maintain GMP compliance.Responsibilities:

  • Support and maintain the PMI Solutions Quality Management System (QMS)
  • Work with Analytical Development and other GMP functional areas to close out deviations, investigations, and CAPAs in a timely manner
  • Review executed documents including batch records, engineering reports, and validation reports for regulatory compliance and adherence to PMI’s procedures
  • Represent Quality Assurance during audits and perform internal and external auditing
  • Provide support to product development and analytical development to ensure compliance with cGMPs and applicable regulatory requirements
  • Facilitate vendor management processes
Job Requirements
  • Requires a Bachelor’s degree in a pharma.
  • Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience is desirable
  • Requires a minimum of 2+ years of experience in Quality Assurance or Regulatory Compliance Management
  • Experience in pharmaceutical environment; excellent knowledge of cGMP, ICH, USP, and global compendium regulations and guidance
  • Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOPs or technical reports
  • Auditing experience desirable
  • Travel may be required, up to 5%
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