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Senior Officer, Quality Compliance
Hikma PharmaceuticalsSr. Officer, Quality Compliance at Hikma Pharmaceuticals supporting compliance and quality in pharmaceutical production.
About the role
Key responsibilities & impact- Preparing and reviewing documents generated by Quality Compliance, as well as continuously following up on CAPAs and commitments made to regulatory authorities.
- Conducting & coordinate cGxP training.
- Assist in providing regulatory compliance guidance and policies for the company.
- Performing other job-related duties as assigned by the direct manager.
- Generating, reviewing, and approving Quality Agreements.
- Conducting all compliance tasks required for cleaning validation activities and the introduction of new molecules and new equipment.
- Handling and hosting external inspections.
- Prepare/review the documentation needed for inspections.
- Conducting internal (on-site) and external (local suppliers) audits.
- Handling internal and external customer complaints and inquiries professionally.
- Prepare/review Quality compliance annual product review reports.
- Conduct/coordinate internal customers’ annual feedback.
- Prepare/review quality risk management reports.
- Prepare/review change controls.
- Performs other related duties or assignments as directed
Requirements
What you’ll need- 2–5 years of relevant experience in the pharmaceutical industry in the QA / compliance field
- Bachelor's degree in Chemistry, Chemical Engineering, pharmaceutical Engineering, pharmacy, or related scientific field
- Very good English (written and spoken)
- Proficiency in MS Office (Word, Excel, PowerPoint)
- Familiarity with SAP (preferred)
- Knowledge of FDA Current Good Manufacturing Practices (cGMP)
- Cleaning Validation Experience is a plus
- Lead Auditor certification is a plus
- Excellent business communication skills
- Strong knowledge of international regulatory requirements (e.g., FDA, EU GMP, PIC/S, SFDA, JFDA)
- Computer literacy with demonstrated ability to work with electronic quality systems (QMS tools, Excel‑based trackers, dashboards, Minitab)
Benefits
Comp & perks- Wellbeing is prioritised
- Inclusive approach values contributions from all
ATS Keywords
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Hard Skills & Tools
Quality CompliancecGxP trainingregulatory compliancecleaning validationauditsquality risk managementchange controlsQMS toolsMinitabFDA Current Good Manufacturing Practices
Soft Skills
business communicationcustomer serviceinterpersonal skillsorganizational skillsprofessionalism
Certifications
Lead Auditor certification