JOB DESCRIPTION
Job Title: | Stability Officer in QC | O*NET Code: | 51-1011.00 (First-Line Supervisors of Production and Operating Workers) |
Job Level: | L4 — Team Leader / Supervisor | Job Code: | WR-Quality-21 |
Sector: | Quality — QC | Company: | Wadi Al-Rafidain Company |
Division: | Stability | Department: | Quality Control |
Section: | Stability | Reports To: |
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Subordinates: |
| Functional Manager |
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Job Purpose |
Lead the stability programme — chamber operations, sample pulls, analytical testing, trending, and reporting — to ensure shelf-life data supports product registration and ongoing compliance. The role acts as the first line of leadership for the team — driving discipline, quality, and continuous improvement on a daily basis, escalating issues quickly, and developing the next generation of specialists. It is also responsible for ensuring that all documentation produced by the team meets data-integrity and audit-readiness standards. |
Key Duties & Responsibilities |
● Own the stability programme and matrix per ICH Q1 across products. ● Supervise stability sample placement, pulls, and analytical testing. ● Monitor stability chambers (temperature, humidity) and respond to excursions. ● Trend stability data and produce annual stability reports. ● Lead OOS / OOT investigations on stability data. ● Coach the stability team and develop their technical skills. ● Schedule shift coverage, assign daily tasks, and balance workload across team members. ● Conduct daily start-of-shift briefings and end-of-shift handovers to maintain operational continuity. ● Identify training needs of team members and deliver on-the-job coaching to close skill gaps. ● Investigate and document incidents, deviations, and near-misses; recommend corrective and preventive actions (CAPA). |
Qualifications & Requirements |
Bachelor's in Pharmacy or Chemistry; M.Sc. preferred.
● 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 |
5+ years in pharmaceutical stability with supervisory time.
● 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 Q1 stability guidelines ● Trend analysis and statistical methods ● Chamber qualification and monitoring Skills ● Programme management ● Investigation writing ● Coaching Abilities ● Sustain attention across long-term studies ● Maintain integrity in stability data ● Support regulatory submissions |
Key Performance Indicators (KPIs) |
● Pulls completed on time — Target: ≥ 98% | Frequency: Monthly | Source: Stability schedule ● Chamber excursions managed — Target: Reported within 1 hour | Frequency: Per event | Source: Chamber log ● Annual stability reports — Target: 100% on time | Frequency: Annual | Source: Stability program |
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: ________________ |