Aqsa Zaman

Date of Birth: 04-04-1996|Nationality: Pakistani | Gender: Female

Email: aqsazaman0404@gmail.com | Phone number: +92 3134261781
Address: 46 Raza Block Allama Iqbal Town, Lahore, Pakistan.

• Professional Summary

Dynamic Pharm D graduate with a proven track record of achievements in the Contract Research Organization
(CRO) and Reading Centre. Over three years of comprehensive experience in the pharmaceutical industry,
with the last two years dedicated to excelling in management roles within a CRO. Acknowledged for a robust
blend of qualitative and quantitative skills as a Quality Assurance Manager, consistently lauded for tenacity,
passion, and adept problem-solving abilities. Starting as a QA officer in the Pharma industry, I progressed
seamlessly into roles within CRO and Reading Centre. Ambitious and goal-oriented, aspiring to further
advance as a Lead GCP and ISO auditor while leveraging a strong foundation in both pharmaceutical and CRO
environments.

• Working Experience
02/10/2023 – CURRENT Sunnyvale, United States
QUALITY ASSURANCE SERVICES MANAGER | OIRRC

CAPA Management (Corrective and Preventive Actions):

➢ Implemented corrective actions based on audit findings, contributing to continuous improvement.
➢ Improved the efficiency of the CAPA process, resulting in quicker resolutions and reduced
recurrence of issues.
➢ Successfully tracked and documented corrective actions to meet regulatory requirements.
SOP Writing (Standard Operating Procedures):
➢ Developed and updated comprehensive SOPs to ensure consistency and adherence to quality
standards. Streamlined SOP review processes, enhancing clarity and usability.
➢ Trained team members on SOPs, ensuring understanding and compliance.
Electronic Database Management:
➢ Implemented and managed electronic databases to streamline data storage and retrieval
processes.
➢ Ensured data integrity, security, and compliance with relevant data protection regulations.
➢ Improved accessibility and usability of electronic databases for the entire team.
Audit Hosting and Conduction:
➢ Successfully hosted and facilitated audits from external stakeholders.
➢ Prepared and organized documentation for audits, resulting in positive outcomes.
Compliance Management:
➢ Conducted regular compliance audits to identify and rectify non-compliance issues. Implemented
strategies to stay abreast of evolving regulatory changes impacting the industry.

06/01/202 – 01/10/2023 Lahore, Pakistan

QUALITY ASSURANCE SERVICES MANAGER | ORCITRIALS PVT LTD

Global Audits and Due Diligence:

➢ Led virtual audits and due diligence for multinational CROs and pharmaceuticals.

1
 Internal Audit Excellence:
➢ Conducted internal audits, pinpointing process weaknesses and implementing solutions for
improved outcomes.
Comprehensive Training Initiatives:
➢ Provided comprehensive training with accurate record-keeping to meet regulatory requirements
and best practices.
➢ Developed and delivered training sessions covering CAPA, 5 Whys Worksheet, QA SOPs, and GCP.
Quality Documentation Development:
➢ Developed SOPs, policies, and a Quality Manual, serving as essential guides for the organization to
maintain compliance.
➢ Experience in hosting, managing, and preparing for DRAP inspections & ISO 9001:2015 audits.
International Due Diligence Leadership:
➢ Successfully led approximately 15 due diligence processes for international clients from APAC,
Europe, and the US.
➢ Demonstrated expertise in ensuring thorough evaluations and risk assessments for diverse global
stakeholders.
Comprehensive Management Responsibilities:
➢ Held key responsibilities in Vendor Management, CAPA Management, and Risk Management.
➢ Successfully prepared and submitted 10 proposals and budgets, showcasing adept project
management skills.
Regulatory Inspection and Audit Preparedness:
➢ Successfully led the organization in hosting, managing, and preparing for DRAP inspections & ISO
9001:2015 audits.
➢ Ensured the team's readiness and responsiveness to regulatory scrutiny and audits.
Versatility in Professional Roles:
➢ Demonstrated versatility with expertise in business development and clinical operations.
➢ Successfully secured international projects through effective budgeting and proposal development.

22/02/2021 – 31/12/2021 Lahore, Pakistan

QUALITY ASSURANCE Officer | Pharmasol Pvt Ltd

➢ Comprehensive QA Plans Development and Implementation

➢ Risk Assessment and Mitigation
➢ Client Relationship Building
➢ Quality Metrics Monitoring
➢ Product Inspection and Progress Monitoring
➢ Compliance Monitoring and Enforcement
➢ Root Cause Analysis and Issue Resolution
➢ Process and System Audits
➢ Customer Complaint Investigation and Corrective Actions
➢ Quality Assurance Training Delivery

• Education and Professional Certifications

2
 BS. Pharmacy (2021)
University College of Pharmacy, University of The Punjab
GCP (2022)
NIDA
ISO 9001 Internal Audit Training (2023)
QMS 9000
Lean Six Sigma White Belt (2023)
Educate 360
HIPPA Compliance (2023)
OIRRC
GDPR Compliance (2023)
OIRRC

• Professional Skills

• Team Lead & Management • Research Writing

• Time Management • Proposal writing
• Exceptional communication skills • Training & Audits Skills
• GCP knowledge • Team Development Strategies
• Quality Manual Writing • Public Speaking
• Audit reports Writing • Standard Operating Procedures
• Clinical Research • Develop Training Programs

• Publications

• A Population based study on self medication practice (KCMJ · Jun 10, 2022)

• Awareness of covid 19 among pharmacy students of Pakistan

(Advances in Medical, dental and health Sciences · May 30, 2022)

• Clinical Trials

Therapeutic Area Phase Key Responsibilities

Ophthalmology 3 Facilitated the preparation and hosting of Study Close-Out Audits,
ensuring comprehensive examination and closure of clinical trial
activities.

Ophthalmology 2 Facilitated the preparation and hosting of Study Close-Out Audits.

Oncology 3 Spearheaded the thorough preparation, execution, and hosting of the

Study Start-Up Audit, demonstrating a commitment to regulatory
compliance and effective trial initiation.

Infectious Disease (Covid-19) 3 Preparation execution and hosting of Study Start-Up Audit.