Maliha Naaz
Cork,
Summary
Quality Assurance Specialist with over 5 years of experience in the pharmaceutical industry, ensuring compliance with GMP, FDA, and regulatory guidelines. Experienced in conducting audits, managing CAPAs, investigating deviations, and reviewing documentation to maintain product quality and safety. Proficient in process validation, risk assessment, and quality control procedures to support continuous improvement and regulatory compliance. Strong collaborator with cross-functional teams to enhance operational efficiency and uphold industry standards. Committed to maintaining product integrity and patient safety in fast-paced pharmaceutical environments.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Gilead Sciences
04.2023 - Current
- Ensure compliance with GMP, FDA, and other regulatory requirements in pharmaceutical operations
- Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with relevant departments.
- Review and approve batch records, SOPs, and other quality documentation to ensure accuracy and compliance
- Support process validation, risk assessments, and change control activities for continuous improvement
- Collaborate with cross-functional teams (manufacturing, regulatory, and R&D) to enhance quality processes
- Monitor non-conformance reports (NCRs) and implement corrective actions to minimize deviations
- Drive continuous improvement initiatives, identifying process gaps and implementing best practices
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Quality Assurance Specialist
Abellio Production Ltd
09.2021 - 03.2023
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies
- Monitored product standards and quality-control programs, and review PQRs
- Provided expert guidance on document formatting, artwork revisions and approval processes, utilizing comprehensive knowledge of regulatory guidelines to ensure overall compliance
- Investigate non-conformances and process issues as needed, keep track of any assigned inspections, and finish CAPA actions by the predetermined deadlines
- Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms
- Utilized root cause analysis techniques to identify underlying issues contributing to product defects or customer complaints.
- Streamlined the documentation process, ensuring adherence to industry standards and regulatory requirements.
- Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
Clinical Pharmacist
RVM Medical Institute
01.2019 - 07.2020
- Generated and updated policies and processes related to prescribing and prescription process
- Provided consultations and answered inquiries from patients, healthcare professionals and Physicians regarding drugs, potential side effects and specified use
- Advised patients on potential drug interactions and side effects, as well as how to maximize Efficacy with proper dose timing and medication storage
- Evaluated patient histories to assess medication compliance and spot issues such as doctor shopping or excessive usage
- Checked medications for content, accuracy and completeness of all drug packaging and labelling to provide final verification of prescription
- Educated patients on possible drug interactions, potential side effects and optimal methods of administration
- Trained pharmacy residents and interns on clinical care and medication dispensing
- Implemented information security protocols to protect financial and patient data and reduce potential for data breaches
- Compared prescription details against safety standards and insurance requirements to support patients
- Partnered with physicians and other members of healthcare team to optimize patient care through effective use of medications
Quality Assurance Associate
R&D Chem Pharma
06.2018 - 12.2018
- Supported audit preparation through research, analysis and presentation development
- Generated quality control reports for returned products to identify and communicate patterns
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions
- Assessed quality of finished products with careful inspections
Education
Master's degree - Pharmaceutical Regulatory Affairs
South East Technical University
Carlow, County Carlow08.2021
Doctoral degree - Pharmacy
JNTUH
India07.2020
Skills
- Quality management
- Quality systems
- Communication skills
- Corrective and preventive actions
- Quality management systems
- GxP knowledge
- Quality assurance
- Documentation review
- Document control
- Interpersonal skills
- Problem-solving skills
- Regulatory compliance
Certification
Six Sigma Yellow Belt
Timeline
Quality Assurance Specialist
Gilead Sciences
04.2023 - Current
Quality Assurance Specialist
Abellio Production Ltd
09.2021 - 03.2023
Clinical Pharmacist
RVM Medical Institute
01.2019 - 07.2020
Quality Assurance Associate
R&D Chem Pharma
06.2018 - 12.2018
Six Sigma Yellow Belt
Master's degree - Pharmaceutical Regulatory Affairs
South East Technical University
Doctoral degree - Pharmacy
JNTUH
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