Quality Assurance Manager - Orta Laboratories
(2026-01)
- Establishment and maintainance of robust QMS
- Oversee the Deviation, OOS/OOT, and Change Control systems
- Manage Product Recall and Product Complaint systems
- Data Integrity (ALCOA+) principles across all laboratory and manufacturing systems, auditing electronic records to ensure regulatory adherence
- Authorization of the release of finished products (Batch Release), assure compliance with approved specifications, marketing authorization, and cGMP.
- Implementation of Risk Management (QRM) strategies (ICH Q9) to identify potential hazards and mitigate risks early in the production cycle.
- To plan, execute and implement process validations of all dosage forms running in Zamko Pharma (Pvt.) Ltd
- Layout plans approval for new sections inZamko Pharma (Pvt.) Ltd
- Pharmacovigilance program implementation.
- Regulatory correspondence (audit and legal matters).
- Focal person for govt. tender business and prequalification of products.
- Cleaning validations, thermal mappings, Sterilizers validations.
- Internal auditing of Quality Control Laboratory.
- In Process Quality Control Incharge
- Utilities Validations.
- Stability studies of Dosage forms.
- Quality risk management.
- Team management for inspection.
- Team player for successful audit of cGMP inspections conducted by Drap.
- Team lead for grant of additional section inspection by Drap.
Proprietor at Retail Pharmacy - NEW Al-Hewaan Medicose
(2025-01 - 2025-12)
- Drug Utilization Review (DUR): Diligence in identifying contraindications, therapeutic duplications, and potential allergic reactions.
- MTM (Medication Therapy Management): Comprehensive medication reviews (CMRs) performing monthly.
- Counseling: ability to translate "medical-speak" into layperson terms to improve adherence.
- Inventory Management: Success in reducing "dead stock," managing out-of-dates, and maintaining a high inventory turnover rate.
- Regulatory Compliance: Strict adherence to DEA regulations, state laws, and HIPA. "perfect" internal or state board audits.
- Technician Training: Mentor staff to improve their accuracy or efficiency.
- Conflict Resolution: De-escalate "hangry" or frustrated patients with empathy and professionalism.
- Interprofessional Collaboration: Clarify prescriptions and resolve insurance hurdles (Prior Authorizations).
Quality Assurance Manager - 3S pharmaceuticals (pvt) ltd
(2020-07 - 2024-12)
- To implement, monitor and maintain pharmaceutical Quality system.
- To implement cGMP in pharmaceutical manufacturing.
- To monitor and control manufacturing environment.
- To monitor hygiene of personnel deployed at manufacturing facility.
- To enforce risk based thinking through Quality risk management principles.
- To handle, review and investigate market complaints and recalls and provision of effective Corrective and Preventive actions (CAPA).
- To conduct training on technical aspects for whole manufacturing facility.
- To plan, execute and implement process validations of all dosage forms running in 3S Pharma (Pvt.) Ltd
- Layout plans approval for new sections in 3S Pharmaceuticals (Pvt.) Ltd.
- Pharmacovigilance program implementation.
- Regulatory correspondence (audit and legal matters).
- Focal person for govt. tender business and prequalification of products.
- Cleaning validations, thermal mappings, Sterilizers validations.
- Internal auditing of Quality Control Laboratory.
- In Process Quality Control Incharge
- Utilities Validations.
- Stability studies of Dosage forms.
- Quality risk management.
Distribution Manager - A'raf Pharmaceuticals (Pvt) Ltd.
(2018-05 - 2020-06)
- Ensures GDP compliance: Guarantees all operations meet Good Distribution Practices.
- Manages licensing: Keeps company distribution licenses valid and up to date.
- Oversees controlled substances: Tracks narcotics and psychotropics per federal laws.
- Hosts audits: Acts as the primary point of contact for government health inspectors.
- Monitors climate: Validates temperature and humidity tracking in warehouses and trucks.
- Secures cold chain: Enforces strict protocols for life-saving biologicals and vaccines.
- Handles recalls: Executes rapid market withdrawal of defective or compromised batches.
- Manages damage: Evaluates returned or damaged goods to determine safe disposal.
- Implements FEFO/FIFO: Enforces First-Expired, First-Out rules to minimize waste.
- Optimizes stock levels: Calculates safety stock to prevent both shortages and overstocking.
- Secures transit: Partners with verified logistics vendors to stop cargo theft and counterfeiting.
- Tracks shipments: Utilizes digital inventory systems for end-to-end product traceability.
- Writes SOPs: Develops Standard Operating Procedures for storage, packing, and dispatch.
- Trains staff: Educates warehouse handlers on safe chemical and medicine handling.
- Liaises internally: Collaborates with Manufacturing, Sales, and Quality Assurance teams.
Senior Quality Assurance Officer - 3's Pharmaceuticals (Pvt) Ltd.
(2015-05 - 2018-04)
- Grants line clearance: Inspects manufacturing and packaging areas before production begins to ensure no materials or labels from previous batches remain.
- Monitors in-process controls: Routinely checks critical parameters during production, such as tablet hardness, capsule weights, leak tests, and seal integrity.
- Enforces hygiene protocols: Supervises cleanroom behavior, gowning procedures, and sanitation standards for all personnel on the production floor.
- Reviews executed batch records: Audits Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time for completeness and accuracy.
- Upholds ALCOA+ standards: Verifies that all data entries are contemporaneous, legible, and traceable to prevent data manipulation.
- Issues logbooks and labels: Controls the issuance and reconciliation of high-security documents, product labels, and status tags (e.g., Approved, Quarantined, Rejected).
- Identifies anomalies: Logs immediate shop-floor deviations, equipment malfunctions, or environmental monitoring failures.
- Supports Root Cause Analysis: Gathers initial data, interviews operators, and helps the QA management team during Out-of-Specification (OOS) and deviation investigations.
- Tracks CAPA implementation: Verifies that approved Corrective and Preventive Actions are physically applied on the production lines.
- Performs material sampling: Draws representative samples of raw materials, in-process blends, and finished products for Quality Control (QC) laboratory testing. [1]
- Manages retention samples: Organizes and stores reference control samples under controlled environmental conditions for future shelf-life verification.
- Monitors facility utilities: Reviews daily temperature, differential pressure, and humidity logs for critical areas like HVAC systems and purified water plants.
- Initiates change controls: Routes operational change requests through the documentation system when modifications to processes or equipment are proposed.
- Assists in internal audits: Participates as a co-auditor during internal self-inspections to identify regulatory compliance gaps.
- Prepares audit rooms: Organizes requested batch files, validation protocols, and training records during external inspections by health authorities.
Quality Assurance Officer - Hansel Pharmaceuticals (Pvt) Ltd.
(2013-04 - 2015-04)
- Performs line clearance: Verifies that manufacturing and packaging lines are completely clean and free of leftover materials, labels, or documentation from previous batches before a new run starts.
- Checks in-process controls (IPC): Conducts routine physical testing during production, such as monitoring tablet thickness, friability, weight variations, and packaging leak.
- Monitors gowning compliance: Ensures all operators follow correct hygiene, sanitization, and cleanroom gowning procedures before entering production zones.
- Verifies real-time entries: Checks that operators fill out Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) contemporaneously to maintain data integrity (ALCOA+ principles).
- Issues operational logs: Distributes, collects, and archives equipment logbooks, room logs, and cleaning records.
- Manages status labeling: Places authorized labels (such as Quarantined, Under Test, Approved, or Rejected) on raw materials, intermediate blends, and finished product pallets.
- Collects routine samples: Draws representative composite samples of raw materials, in-process blends, and finished goods, transferring them safely to the Quality Control (QC) laboratory. [1]
- Maintains retention rooms: Organizes and tracks control retention samples, ensuring they are stored under specific temperature and humidity conditions for future reference.
- Assists utility monitoring: Records daily environmental parameters, including temperature, humidity, and pressure differentials in controlled manufacturing rooms.
- Flags production deviations: Immediately reports any processing anomalies, machine malfunctions, or environmental cross-contamination risks to the Senior QA Officer.
- Documents initial deviations: Drafts the preliminary paperwork and timeline logs for basic deviations or spills on the shop floor.
- Follows up on housekeeping: Monitors production areas to ensure corrective actions regarding cleanliness or organization are instantly resolved
