Quality Assurance Officer at Gilead Pharmaceutical Limited

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
• 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
• 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.).

Qualifications

• BS degree in Technical or Scientific discipline preferably Microbiology
• 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
• 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