Sr. Officer, QA
Hikma Pharmaceuticals PLC · Al Salt, Balqa, Jordan
11-50 employees
22 h ago
Closes today
Mid (2-5 yrs)
Full-time
Jordan
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About the role
Oversee quality assurance by managing deviations, investigations, and change controls to ensure product compliance with cGMP requirements. Perform shop floor monitoring, line clearances, and review batch manufacturing records and validation protocols.
What they look for
Veeva
Analytical Testing
Data Analysis
Data Integrity
LIMS
Laboratory Instrumentation
GMP
SOPs
Deviations
Investigations
Quality Auditing
Quality Control
CAPA
Change Control
Technical Writing
Validation
Requirements
Requires a Bachelor's degree and a minimum of 4 years of relevant work experience. Strong expertise in handling deviations and investigations is essential.
Full description
Sr. Officer – QA position, Job Responsibilities:
- 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
Qualifications:
- 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
Behavioral Competencies:
- Collaboration & Teamwork, Initiative & Drive for Results, Resilience & Adaptability, Change & Innovation, Problem Solving & Decision Making
