JOB DESCRIPTION
Job Title: | Junior Stability Specialist | O*NET Code: | 19-4099.01 (Quality Control Analysts) |
Job Level: | L2 — Junior Specialist | Job Code: | WR-Quality-09 |
Sector: | Quality — QC | Company: | Wadi Al-Rafidain Company |
Division: | Stability | Department: | Quality Control |
Section: | Stability | Reports To: |
|
Subordinates: |
| Functional Manager |
|
Job Purpose |
Conduct stability testing of pharmaceutical products through their declared shelf life under various ICH conditions, supporting the company's stability programme and product registrations. The role applies specialist expertise within the Quality Control domain, ensuring that day-to-day work meets technical, regulatory, and quality requirements while contributing to the unit's continuous-improvement agenda. The job-holder is expected to operate with a high degree of autonomy on routine tasks while escalating complex matters appropriately. |
Key Duties & Responsibilities |
● Place stability samples in chambers (long-term, intermediate, accelerated) per protocol. ● Conduct scheduled stability pulls and analytical testing per stability matrix. ● Maintain chamber log books and chamber-condition monitoring. ● Document and trend stability results and support OOS/OOT investigations. ● Support stability-related regulatory submissions and product registrations. ● Apply specialist technical knowledge to ongoing operations and contribute to continuous improvement initiatives. ● Maintain accurate records and documentation in line with regulatory and quality-system requirements (ALCOA+, ISO 9001). ● Support audits, inspections, and certification programmes by providing technical evidence on request. ● Participate in cross-functional projects to address operational challenges and improvement opportunities. |
Qualifications & Requirements |
Bachelor's in Pharmacy or Chemistry.
● Languages: Working proficiency in Arabic (native or near-native) and English (intermediate or above for technical reading and reporting). ● Computer literacy: Proficiency in Microsoft Office (Word, Excel, PowerPoint) and the company's enterprise systems (ERP/LIMS/CMMS as applicable to the role). |
Experience |
0–2 years' experience in stability or QC.
● Track record of successful delivery in a comparable role within a regulated or quality-driven environment. ● Demonstrated ability to operate within an Iraqi-Group setting, working with internal stakeholders across functions and external regulators / partners. |
Skills & Competencies (Knowledge, Skills and Abilities) |
Knowledge ● ICH stability guidelines (Q1A-Q1F) ● Pharmacopoeial assay methods ● LIMS and stability tracking Skills ● Stability protocol execution ● Analytical testing ● Trend analysis basics Abilities ● Maintain attention across long studies ● Manage timelines for multiple studies ● Document carefully |
Key Performance Indicators (KPIs) |
● Stability pulls on time — Target: ≥ 98% | Frequency: Monthly | Source: Stability schedule ● Chamber excursions — Target: Reported within 1 hour | Frequency: Per event | Source: Chamber log ● OOS/OOT in stability — Target: Investigated within target | Frequency: Per event | Source: QA tracker |
Prepared by: (Direct Manager) | Reviewed by: (BUHR / HRBP) | Approved by: (Group OD Manager) | Approved by: (Group HR Director) |
Name: ____________ Position: _________ Signature: ________ Date: ____________ | Name: ____________ Position: _________ Signature: ________ Date: ____________ | Name: ____________ Position: _________ Signature: ________ Date: ____________ | Name: ____________ Position: _________ Signature: ________ Date: ____________ |
Acknowledgement This certifies that I have read the job description and I am able to perform all essential duties as outlined. Employee Name: ________________ Signature: ________________ Date: ________________ |