JOB DESCRIPTION
Job Title:
Quality Assurance Pharmacist
O*NET Code:
29-1051.00 (Pharmacists)
Job Level:
L3.5 — Senior Specialist
Job Code:
WR-Quality-33
Sector:
Quality - QA
Company:
Wadi Al-Rafidain Company
Division:
QA Pharmacy
Department:
Quality Assurance
Section:
QA Pharmacy / Batch Release
Reports To:
 
Subordinates:
 
Functional Manager
 
 
Job Purpose
Provide qualified-pharmacist oversight in the QA department — review and approve batch manufacturing records, in-process and finished-product results, and final batch-release decisions; lead internal audits, quality-risk assessments, and quality KPI reporting; and ensure every batch released is safe, effective, and fully compliant with cGMP, MOH, and pharmacopoeial requirements. The role applies specialist expertise within the Quality Assurance 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
●  Review batch manufacturing records (BMRs), in-process check sheets, and final analytical results before batch release.
●  Approve or reject batches based on full review of the manufacturing and QC documentation chain.
●  Lead pharmacy-led investigations of deviations, OOS / OOT, customer complaints, and adverse events.
●  Approve change-controls, process changes, and SOPs that affect product quality from a pharmacy perspective.
●  Verify pharmaceutical formulation adherence, packaging compliance, and labelling accuracy in line with the registered dossier.
●  Liaise with R&D, Regulatory Affairs, and Production on technical pharmacy matters.
●  Support MOH inspections, customer audits, and pharmacist-led regulatory reviews on site.
●  Train production and QC staff on pharmaceutical aspects of GMP, batch documentation, and data integrity (ALCOA+).
●  Plan and conduct internal QA audits across production, QC, warehouse, and engineering areas; track corrective actions to closure.
●  Lead quality-risk assessments (ICH Q9) for new products, processes, equipment, and significant changes.
●  Monitor and report quality KPIs (right-first-time, deviation rates, CAPA effectiveness, complaint trends) to QA leadership monthly.
●  Review and update SOPs, policies, and quality documentation to keep them aligned with current GMP and MOH expectations.
●  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 (B.Pharm); registered with the Iraqi Pharmacist Syndicate. M.Sc. in Pharmaceutical Sciences or Industrial Pharmacy 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
Minimum 4–6 years in pharmaceutical QA or QC, including direct experience with batch-record review and batch-release decisions.
 
● 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
●  Pharmaceutical cGMP and ICH Q7-Q10
●  Batch record review and release procedures
●  Pharmacopoeial standards (USP, BP, EP)
●  Pharmacovigilance and complaint handling
●  Internal audit methodology and quality KPIs
●  ICH Q9 Quality Risk Management
Skills
●  Documentation review and approval
●  Investigation and root-cause analysis
●  Technical writing for regulatory and QA records
●  Cross-functional coordination
●  Audit execution and reporting
●  Risk assessment facilitation
Abilities
●  Apply pharmaceutical judgement decisively on patient-safety matters
●  Resist commercial pressure on release decisions
●  Maintain meticulous accuracy in documentation review
Key Performance Indicators (KPIs)
●     Right-first-time batch release — Target: ≥ 99% | Frequency: Monthly | Source: Release register
●  Batch release within target time — Target: ≥ 95% | Frequency: Weekly | Source: Release tracker
●  Deviation investigations closed — Target: ≥ 90% on time | Frequency: Monthly | Source: QA tracker
●  MOH / customer audit findings — Target: Zero major | Frequency: Per audit | Source: Audit reports
●  Internal audits completed on plan — Target: ≥ 95% | Frequency: Quarterly | Source: Internal audit register
●  Quality risk assessments delivered — Target: Per project plan | Frequency: Per project | Source: Risk register
●  Quality KPI dashboard issued — Target: Monthly by day 5 | Frequency: Monthly | Source: QA reporting
 
Prepared by: (Direct Manager)
Reviewed by: (BUHR / HRBP)
Approved by: (Group OD Manager)
Approved by: (Group HR Director)
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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: ________________