JOB DESCRIPTION
Job Title: | Finished Product Specialist | O*NET Code: | 19-4099.01 (Quality Control Analysts) |
Job Level: | L3 — Specialist | Job Code: | WR-Quality-28 |
Sector: | Quality - QC | Company: | Wadi Al-Rafidain Company |
Division: | Analytical Chemistry | Department: | Quality Control |
Section: | Finished Product | Reports To: |
|
Subordinates: |
| Functional Manager |
|
Job Purpose |
Perform analytical testing of finished pharmaceutical products to verify conformity with registered specifications, support timely batch release, and maintain the integrity and traceability of all laboratory data. 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 |
● Conduct assay, dissolution, content uniformity, and related analytical tests on finished products. ● Operate HPLC, UV, dissolution apparatus, and other analytical instrumentation per validated methods. ● Document all results in laboratory notebooks and LIMS in compliance with ALCOA+ principles. ● Identify and escalate OOS, OOT, and atypical results to the supervisor immediately. ● Calibrate and maintain instruments and reagents in accordance with the schedule. ● Support audits and inspections by retrieving raw data and providing technical evidence on request. ● 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 degree in Pharmacy, Chemistry, or Pharmaceutical Sciences.
● 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 |
Minimum 2–4 years in pharmaceutical QC finished-product testing.
● 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 ● Pharmacopoeial methods (USP/BP/EP) ● HPLC, dissolution, UV spectroscopy ● Data integrity & ALCOA+ Skills ● Analytical instrumentation operation ● Detail-oriented documentation ● Method execution and troubleshooting Abilities ● Sustain accuracy under repetitive testing ● Recognise out-of-trend results ● Resist commercial pressure on data |
Key Performance Indicators (KPIs) |
● Tests completed on schedule — Target: ≥ 95% | Frequency: Weekly | Source: LIMS ● Right-first-time results — Target: ≥ 95% | Frequency: Monthly | Source: LIMS ● Documentation errors — Target: ≤ 1% | Frequency: Monthly | Source: QA review |
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: ________________ |