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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
Location:
As-Salt, JO
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