Sr. Officer, Quality Compliance
Hikma Quality
Employer Active
Posted 22 hrs ago
Send me Jobs like this
Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
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
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Sr. Officer
- Quality Compliance
Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at abuse@naukrigulf.com
Hikma Quality
For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission. As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 9 R&D centers across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients.
https://talents.hikma.com/job/Sahab-Sr_-Officer%2C-Quality-Compliance/1392088433/