Job Description

Roles & Responsibilities

We are looking for a talented Sr. Officer, Quality Compliance to join us. At Hikma you ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.

If you want to be part of a team that cares about impact, this is the place for you.

Key Responsibilities:

• 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

Desired Candidate Profile

Experience:

• 2 5 years of relevant experience in the pharmaceutical industry in the QA / compliance field.

Education:

• Bachelor s degree in Chemistry, Chemical Engineering, pharmaceutical Engineering, pharmacy, or related scientific field.

Language:

• Very good English (written and spoken).

Required Skills:

• Proficiency in MS Office (Word, Excel, PowerPoint).
• Familiarity with SAP (preferred).
• Ability to work independently and manage multiple tasks.
• Strong teamwork and collaboration skills.
• Knowledge of FDA Current Good Manufacturing Practices (cGMP).
• Quick learner with flexibility and adaptability.
• Active listening and strong motivation.
• Cleaning Validation Experience is a plus
• Lead Auditor certification is a plus.
• Excellent business communication skills
• Formal training or certification in GMP, Data Integrity, Quality Systems, or Risk Management (ICH Q9) is plus.
• 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)
• Proven experience working within a GMP regulated manufacturing site, preferably solid dosage forms
• Demonstrated participation in inspection responses, risk assessments, and quality improvements initiatives.
• Experience supporting or maintaining Quality Systems and SOPs in alignment with site and corporate procedures
• Strong attention to detail and compliance mindset
• Sound analytical and critical thinking skills
• Ability to prioritize, manage deadlines, and handle multiple quality activities
• Effective written and verbal communication skills (both: English & Arabic)
• High level of integrity, accountability, and professional judgment
• Ability to work independently while escalating quality risks appropriately
• Ability to work cross functionally with different departments internally and externally.
• Ability to work under pressure with a high level of flexibility