Areej Shafiq

Ensured strict adherence to GMP and GDP standards and product quality in manufacturing and packaging processes.

Key Responsibilities:

• Conducted line clearance before the start of manufacturing and packaging operations to ensure the area was free of materials from previous batches.

• Performed in-process checks at critical control points, including granulation, compression, coating, filling, sealing, and labeling stages.

• Verified usage of correct raw materials and packaging materials as per the batch manufacturing record (BMR) and batch packaging record (BPR).

• Collected and submitted in-process samples, finished product samples, and reference/retention samples to Quality Control and microbiology labs.

• Ensured real-time documentation of IPC activities and maintained compliance with SOPs and cGMP guidelines.

• Monitored environmental conditions and equipment cleanliness prior to and during manufacturing.

• Identified, reported, and assisted in investigating any deviations, non-conformances, or incidents.

• Coordinated with the Quality Control and Production teams to resolve quality issues and minimize batch rejection or rework.

• Participated in internal audits, inspections, and supported readiness for regulatory audits by maintaining thorough documentation.

• Issued manufacturing and packaging orders, maintained IPC logs, and supported QA leadership in special assignments and reporting.

As a Production Officer in the Sterile Manufacturing Unit, I was responsible for supervising the aseptic production of sterile injectable products, ensuring strict adherence to cGMP and aseptic techniques. My role focused on managing operations within classified cleanrooms, monitoring environmental conditions, and ensuring compliance with quality and regulatory standards. I worked closely with cross-functional teams including Quality Assurance, Engineering, and Validation to maintain the sterility assurance level and operational efficiency of sterile product lines.

Key Responsibilities:

• Supervised aseptic manufacturing of sterile injectable solutions such as KCl, Dextrose, NaCl, and Water for Injection (WFI).

• Ensured cleanroom operations complied with environmental controls, gowning procedures, and microbiological requirements.

• Conducted routine monitoring of differential pressure, temperature, humidity, and viable/non-viable particulate levels in clean areas.

• Oversaw sterilization processes including autoclaving, filtration, equipment cleaning, and depyrogenation cycles.

• Ensured proper documentation of batch manufacturing records, equipment logs, and controlled documents in real-time.

• Coordinated with the Quality Assurance department for in-process checks, batch release, and deviation handling.

• Monitored personnel behavior and aseptic techniques inside Grade A/B areas to ensure contamination control.

• Participated in media fill trials, process validations, and readiness for internal and external audits.

• Supported continuous improvement initiatives to enhance line efficiency and reduce production downtime.

• Trained and guided junior staff on sterile handling procedures and compliance practices.

As a Management Trainee Pharmacist in the Sterile Production area, I was assigned to the Quality Assurance department to support real-time quality monitoring of aseptic manufacturing activities. My role involved hands-on exposure to cleanroom practices, documentation review, and in-process control within the framework of cGMP and quality standards. I gained critical experience in sterile manufacturing protocols, contamination control, and the QA oversight functions required to ensure product sterility and regulatory compliance.

Key Responsibilities:

• Assisted in QA supervision of sterile production operations, including batch formulation, filtration, and aseptic filling.

• Monitored adherence to aseptic techniques and cleanroom protocols by production staff in Grade A/B areas.

• Performed in-process checks and line clearance activities in coordination with IPC team.

• Verified and maintained production documentation such as batch records, cleaning logs, and equipment usage logs.

• Participated in media fill validation activities and preparation of related QA documentation.

• Supported environmental monitoring activities (viable and non-viable particulate monitoring) within sterile zones.

• Reported any deviations, non-conformances, or incidents to senior QA personnel and assisted in CAPA implementation.

• Coordinated with Production and QC teams to ensure smooth workflow and timely batch release.

• Gained knowledge of regulatory guidelines (cGMP, WHO, PIC/S) applicable to sterile pharmaceutical manufacturing.

Performed in-process quality checks during manufacturing and packaging operations. • Ensured compliance with GMP and SOPs across all production activities.

• Inspected raw and packaging materials and verified batch documentation.

• Reported deviations and supported QA team in root cause analysis and documentation.

• Coordinated with QC for timely sampling, testing, and batch release.

• Provided knowledgeable clinical advice to relieve and improve patients' everyday conditions.
• Collaborated with hospital staff to maintain patient care continuity and minimise risks.
• Reviewed patient records to compare current and past medicine intake and history.
• Reviewed physician orders to assess prescription accuracy and safety.
• Provided instructions and requirements to patients regarding medications.
• Provided patient consultation to address queries and concerns.
• Evaluated condition and health problems to verify medications prescribed met patient needs.
• Educated patients to maintain exercise and diet to support health lifestyle.
• Educated patients about correct medication dosage and storage.
• Advised patients on drug incompatibility and contraindications, minimising likelihood of ill effects.
• Recorded medication plans and patient progress to maintain accurate information.
• Monitored patient status to assess risks and adverse side-effects.
• Informed patients regarding medicine ingredients and dosages to gauge allergic symptoms.
• Informed patients regarding preventative measures and procedures to maintain healthy habits.
• Provided information regarding contradicting medicines to avoid during current condition.
• Labelled medication with dose and administration guidance.
• Identified untreated health issues to determine appropriate medication therapy.
• Stored medication according to specific temperature instructions.
• Processed and dispensed prescriptions to doctors' instructions.
• Advised patients regarding required immunisations to boost health.

• Worked under supervision of licensed pharmacist by shadowing, asking questions and responding to feedback.
• Assisted pharmacy staff in preparing medications and filling orders.
• Followed instructions in methodical way to minimise risk of errors.
• Took initiative to support busy teams and complete tasks with minimal supervision.