Dr. Atiya Siddiqui
Leesburg
Summary
Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Quality Assurance Documentation Associate
Ambiopharm inc.-Georgia
06.2021 - 06.2024
- Assist in the development and maintenance of document filing systems for storage of controlled documents, including but not limited to change controls, deviations, CAPAs, BPRs, analytical data, validations, laboratory notebooks, and logbooks
- Maintain history and current files for SOPs, Certificate of Analysis, Specifications, test method, data sheet, master BPRs and other documentation as necessary
- Fulfill internal and external (FDA inspections and customer audits) requests for controlled documents
- Maintain the logbook for document check-in/outs
- Issuance, scanning and filing of data record sheets
- Generate Daily matrix report
- Info cards issuance in master control
Quality Assurance Associate
Ambiopharm inc.-Georgia
06.2021 - 06.2023
- Review and release of raw materials, Ensure that all materials are reviewed and released within the required timeframe
- Work cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required
- Collaboration with the QA Manager and Responsible Person to ensure the implementation of effective corrective and preventive actions arising from QA monitoring/inspection activities
- Conducted root cause analysis of recurring issues, leading to long-term solutions and preventing future occurrences.
- Maintained compliance with industry standards and regulatory compliance during managed projects.
- To assist with the investigation of result and complaints and ensure that effective immediate follow up actions are taken
- To perform internal audits against defined quality performance measures and ensure that effective immediate follow up actions are taken
- To assist with the management of quality documentation and the review and approval of all quality documents, e.g
- Achieved customer satisfaction with thorough audits of products, ensuring adherence to standards.
- Improved manufacturing processes by identifying areas of inefficiency and recommending corrective actions.
- Collaborated with cross-functional teams for timely resolution of quality issues and concerns.
- Created and maintained quality management systems to align with industry standards.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Conducted data review and followed standard practices to find solutions.
Senior Manager Operations (Quality control, Quality assurance)
TG Parma, Karachi
01.2015 - 01.2019
- Achieved operational excellence by streamlining processes and implementing best practices.
- Implemented and developed operational standards, policies and procedures.
- Implementation of QA/QC Program and assist with the overall QA /QC process improvement
- Contribute to development and implementation of common continuous improvement criteria and measurements
- Develop and implement QA/QC SOP.
Manager (QC/QA)
TG Parma, Karachi
01.2008 - 01.2014
- Successfully manage teams to ensure that goals are understood, provide guidance, mentoring and feedback against performance and development objectives
- Work with all of Development to improve initial release quality, quality of production releases and agile development practices
- Work with multiple development teams to help establish, improve, and implement standards, processes, and procedures
- Develop a high performing team by embedding formal performance development and informal coaching
- Encourage frequent knowledge sharing between team members
- Support the line manager for the area to develop a high performing team by conducting daily and weekly operational performance discussions.
QC Analyst
Wyeth Pharmaceutical, Karachi
01.2004 - 01.2007
- Performed routine testing of pharmaceutical products in a drug manufacturing
- Stability testing, instrumentation lab work on, FTIR, HPLC, GC, TLC
- UV spectrophotometer Raw material testing, finished good testing, microbial assay
- Calibrations of instruments
- Deal with the Raw material and semi-finished product testing
- Performed bio burden, endotoxin, and total organic compound testing
- Performed environmental monitoring
- Maintained instrumentation
- Wrote and revised standard operating procedures following Current Good Manufacturing Practices
- Provided training for newly hired analysts according to current standard operating procedures
- Deal with the Raw material and semi-finished product testing.
Quality Assurance officer
Wyeth Pharmaceutical, Karachi
01.2002 - 01.2003
- Preparation and managing all SOP's of Manufacturing Department
- QC department monitoring and Internal audits
- Production log sheet management and all MO's and maintaining BMRs.
Education
University of Karachi
Skills
- Quality Management Systems
- Corrective Actions
- Risk assessment
- Quality Systems
- Document Control
- Internal Audits
- Quality Control Tests
Affiliations
Member of Pharmacy Council of Pakistan
Seminars Training
- Total Quality Management
- Audit, Compliance and Regulatory validation Documentation & Managements
- Pakistan Japan Business Management
- Total Productive Management Training
Personal Information
Work Permit: Authorized to work in USA for any employer
Certification
- QA102 Current Good Manufacturing Practices (cGMP) – Quality Systems Part 1QA101
- Introduction to the Pharmaceutical Industry
- Introduction to Pharmaceutical Manufacturing Methods
- QA104 FDA, Health Canada, European and International regulatory agencies and structures
- Project One - Comparison Between US and International GMP GuidanceQA202 Current Good Manufacturing Practices (CGMP) - Quality Systems Part 2
NeuAge Institute
Timeline
Quality Assurance Associate
Ambiopharm inc.-Georgia
06.2021 - 06.2023
Quality Assurance Documentation Associate
Ambiopharm inc.-Georgia
06.2021 - 06.2024
Senior Manager Operations (Quality control, Quality assurance)
TG Parma, Karachi
01.2015 - 01.2019
Manager (QC/QA)
TG Parma, Karachi
01.2008 - 01.2014
QC Analyst
Wyeth Pharmaceutical, Karachi
01.2004 - 01.2007
Quality Assurance officer
Wyeth Pharmaceutical, Karachi
01.2002 - 01.2003
University of Karachi
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