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Senior Officer, QA
Hikma PharmaceuticalsQuality Assurance Officer ensuring compliance with cGMP requirements and handling investigations. Responsible for validations, documentation reviews, and quality control processes in the laboratory setting.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance processes, ensuring compliance with cGMP requirements and effective management of deviations, investigations, and validations. Proficient in creating and reviewing SOPs, CAPA, and change controls while conducting thorough risk assessments and quality audits.
Highest-signal resume keywords
GMPDeviationsInvestigationsQuality AuditingValidation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Analytical TestingData AnalysisData IntegrityLaboratory InstrumentationTechnical WritingChange ControlQuality ControlSOPsCAPARisk Assessment
Soft Skills
Safety Awareness
Tools & Technologies
VeevaLIMS
Industry Keywords
CGMPQuality CirclesBatch Manufacturing RecordsDocumentation ReviewsIn-Process Checks
About the role
Key responsibilities & impact- Handle and approve deviations, investigations, and laboratory investigations
- Ensure product compliance with specifications and cGMP requirements
- Approve validation protocols/reports, process validation, stability protocols, APRs, and master batch records
- Review and approve change controls
- Perform risk assessments and review gap analysis reports
- Conduct QA rounds, and in-process checks, documentation reviews, ensuring completeness and compliance
- Create, update, and review SOPs, including periodic review cycles
- Prepare and review CAPA and quarterly reports, ensuring effectiveness tracking
- Issue and follow up on Quality Circles
- Performs line clearance and area verification
- Monitors GMP compliance on the shop floor
- Reviews and approves batch manufacturing records (BMRs)
- Reviews equipment logs, cleaning logs, yield calculations
- Verifies sampling, dispensing, packaging activities
- Issues and receives labels, controlled documents
Requirements
What you’ll need- Bachelor’s degree with minimum 4 years of relevant work experience
- Very good experience in deviations and investigations
- Specialized Skills: Veeva, Analytical Testing, Data Analysis, Data Integrity, LIMS, Laboratory Instrumentation, GMP, SOPs, Safety Awareness, Deviations, Investigations, Quality Auditing, Quality Control, CAPA, Change Control, Technical Writing, Validation
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off