9 Aug 2016
Quality Assurance Officer Job at Gilead Pharmaceutical Limited
Job Title: Quality Assurance Officer
- 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
- 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
- Cell phone reimbursement allowance
- Gym membership reimbursement allowance
- Full medical benefits
How to Apply
Applicants should forward their CVs/Applications to: firstname.lastname@example.org
Note: Only shortlisted applicants will be contacted
Application Deadline: October 10th, 2016
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