Quality Assurance Officer Job at Gilead Pharmaceutical Limited

Gilead Pharmaceutical Limited, is recruiting suitably qualified candidates to fill the position below:

Job Title:  Quality Assurance Officer

Job Description

  • Review/perform daily compliance verification, document results, and report to the MD.
  • Environmental monitoring and documentation e.g. personnel
    monitoring, air bioburden, surface bioburden, temperature, and particle
    counts
  • Collect Environmental Monitoring samples as necessary
  • New staff training
  • Sterility tests, aseptic technique qualifications, and media fill process validations.
  • Prepare/revise operating procedures and specifications
  • Review/approve routine change control requests as designated
  • Verify that raw materials meet specification limits
  • Verify that all documentation is complete
  • Document non-compliance and evaluate if further investigation is needed
  • Submit samples to the appropriate labs for chemical assay and microbial tests
  • Track vendor equipment calibration and maintenance records and assess for deviations
  • Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template
  • Document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions
  • Develop method validations and lead stability studies
  • Maintain quality records (equipment calibration and maintenance,
    training, deviation and complaint investigation, environmental
    monitoring, Certificate of Analysis, clean room certification etc.).
  • Control of product labeling/label accountability
  • Recommend and/or implement improvements in streamlining processes
    and procedures in the areas of compounding, validation, change control,
    laboratory, and risk assessments
  • Lead root cause analysis and corrective and preventive actions for
    audit observations, product complaints, product non-conformances,
    in-process deviations issues related to process controls
  • Direct the investigation of excursions in manufacturing or other
    related operations, resolve the nature of the cause, impact on product
    quality, disposition and corrective actions
  • Perform final review of test data/reports to ensure conformance to
    the established specifications and standard operating procedures,
    perform final disposition of batch.
  • Ensure products are released on time and within specification
  • Verify that product test results meet specification limits
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Qualifications

  • BS degree in Technical or Scientific discipline preferably Microbiology
  • Effective communication skills, both written and verbal
  • Leadership skills and the ability to facilitate the work activities of others
  • Good organizational and time management skills
  • Preferred minimum of 2 years of related experience preferably in the pharmaceutical industries
  • Ability to work autonomously within established procedures and practices
  • Working knowledge of Pharmaceutical Regulations

Additional Benefits:

  • Cell phone reimbursement allowance
  • Gym membership reimbursement allowance
  • Full medical benefits

How to Apply
Applicants should forward their CVs/Applications to: gileadpharm@gmail.com

Note: Only shortlisted applicants will be contacted

Application Deadline:  October 10th, 2016

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