Aisha Amjad
Ardsley,NY
Summary
Results-oriented Pharmacist committed to maintaining the highest standards of quality and
regulatory compliance. Proven expertise in spearheading critical initiatives, including In-Process Control (IPC) protocols, deviation management, OSS investigations, and CAPA development.
Adept at developing and implementing calibration programs, conducting audits, and overseeing
quality assurance operations for sterile and non-sterile products. Ready to contribute to the
implementation and maintenance of an efficient and effective quality system, aiming to drive
organizational success and grow.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Quality Assurance Analyst
Amson Vaccine And Pharma (private) Limited.
07.2021 - 01.2024
- Demonstrated expertise in implementing IPC protocols to guarantee compliance with SOPs at every stage of the manufacturing process.
- Showcased proficiency in identifying and rectifying deviations in the IPC process, ensuring meticulous documentation and effective corrective actions.
- Utilized skills to lead OSS investigations and develop comprehensive Corrective and Preventive Action (CAPA) plans to enhance overall quality.
- Developed and implemented calibration programs for instruments, both internal and external,ensuring accuracy and reliability.
- Conducted thorough audits of Batch Manufacturing Records (BMR) and actively contributed to maintaining stringent quality standards.
- Demonstrated expertise in creating, revising, and maintaining company Standard Operating Procedures (SOPs) to provide clear guidelines for all operational processes.
- Organized inspections and sampling of Raw Materials, in-process products, and finished products through the QA Inspector, ensuring adherence to quality standards.
- Exhibited proficiency in investigating and handling customer complaints, emphasizing a customer-centric approach to maintaining goodwill.
- Managed internal, external, and certification audits, ensuring strict adherence to applicable FDA,GMPs, ISO, WHO, and Drug Act 1976 standards.
- Applied skill in assessing compliance, validation, and qualification with relevant regulatory standards,contributing to a culture of continuous improvement.
Quality Assurance Analyst
Atco Laboratories
01.2020 - 06.2021
- Ensured the implementation and adherence to quality standards throughout the manufacturing process.
- Verified and approved incoming materials by confirming specifications through visual and measurement tests.
- Approved in-process production by confirming specifications and conducting visual and measurement tests.
- Maintained a safe and compliant work environment by following established standards, procedures,and regulations.
- Conducted thorough inspections of various facilities, including productions, quality control laboratory, warehouse, receiving, equipment, qualification, calibration, and maintenance.
- Ensured the accurate weighing of raw material dispensing.
- Collected and manage retention samples in accordance with quality control requirements.
- To ensure that cGMP and SOPs are followed.
Education
Doctor Of Pharmacy - Pharmacy
Jinnah University For Women
Karachi Pakistan 12.2019
Skills
- Excellent technical, supervisory, communication and decision-making skills
- In-depth knowledge of WHO, FDA, ICH, and GMP's Guideline
- Ability to be adaptable, flexible, and capable of working both independently and in teams
- Excellent attention to detail and commitment to quality
- Problem solver and team player with proven leadership qualities
- Strong interpersonal skills to coordinate between various departments
- Strong proficiency in basic PC applications (Excel, Word, PowerPoint, Outlook)
- Proven leadership qualities, serving as a problem solver and team player
Certification
Pakistan Registered pharmacist/RPH
Sindh pharmacy council Karachi, Pakistan, Registartion# 15018
Workshop and Research
Participated in training session on “Good Manufacturing Practice (GMP) ”,organized by Amson
Vaccine & Pharma on March 2023
Timeline
Quality Assurance Analyst
Amson Vaccine And Pharma (private) Limited.
07.2021 - 01.2024
Quality Assurance Analyst
Atco Laboratories
01.2020 - 06.2021
Doctor Of Pharmacy - Pharmacy
Jinnah University For Women