Omar Qadeer
Karachi,Pakistan
Summary
Quality assurance professional with extensive experience in regulatory compliance and audit management at Alpha Labs. Achieved ISO certification and optimized processes, enhancing data integrity and team collaboration. Skilled in developing training programs and driving continuous improvement initiatives to elevate product quality and operational efficiency.
Overview
10
10
years of professional experience
Work History
Deputy Manager Quality (QA/QC)
Alpha Labs (Pvt) Ltd
11.2024 - Current
- Managed a team of 10 QA IPC and QC analysts to ensure seamless daily operations according to the production plan.
- Assigned daily plan for QC staff to sample, test, and release incoming materials, ensuring compliance with quality standards.
- Approved artwork and finished goods samples from clients while maintaining a reference sample library.
- Developed training programs to onboard new employees on company protocols and safety standards.
- Supported senior management in strategic planning initiatives, resulting in acquisition of ISO IMS certification from UK awarding body.
- Prepared monthly progress reports highlighting achievements against established targets to inform management decisions.
- Collaborated with employees, vendors, and stakeholders to coordinate activities and manage risks.
Technical Documentation Consultant
PharmArt Laboratory
07.2023 - 11.2024
- Ensured compliance of all pharmaceutical products and manufacturing processes with local and international regulations, including GMP and GLP.
- Conducted audits and inspections of production facilities to uphold quality standards, implementing corrective actions as needed.
- Developed and monitored quality assurance policies in collaboration with the QC team to uphold product safety.
- Prepared and reviewed regulatory documentation, including validation protocols and batch records, ensuring accuracy and compliance of quality assurance activities.
- Facilitated training sessions on quality assurance principles, GMP, GLP, and regulatory requirements, improving staff understanding and adherence.
Assistant Manager Quality Assurance
S.J. & G. Fazul Ellahie (Pvt) Ltd.
09.2020 - 06.2023
- Ensure that all pharmaceutical products and manufacturing processes comply with local and international regulatory requirements, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Develop, implement, and monitor compliance policies and procedures to maintain adherence to relevant pharmacopeial guidelines and industry standards.
- Conduct regular audits and inspections of production facilities and processes to ensure compliance with established quality standards.
- Investigate and resolve quality-related issues, including deviations, non-conformities, and customer complaints, by implementing corrective and preventive actions (CAPA).
- Identified process optimization opportunities and implemented efficiency improvements in manufacturing and quality assurance operations.
- Coordinate with cross-functional teams, including Production, Research & Development (R&D), and Regulatory Affairs, to develop and implement process improvement plans.
- Maintain accurate and detailed records of all quality assurance activities, including audit findings, CAPA reports, and regulatory submissions.
- Prepared quality reports for management review, highlighting compliance insights and actionable recommendations for quality standard enhancement.
- Conducted training sessions for staff on quality assurance principles, GMP, GLP, and regulatory requirements to promote understanding and adherence.
Senior Executive Warehouse
Maxitech Pharma Pvt Ltd.
05.2019 - 09.2020
- Ensure that all warehouse operations comply with local and international regulatory standards, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Develop and implement warehouse procedures to maintain adherence to pharmacopeial guidelines and industry standards.
- Conduct regular inspections of warehouse facilities and processes to ensure compliance with established quality standards.
- Oversee the storage conditions of pharmaceutical products to maintain product quality and safety, including temperature control and inventory management.
- Manage the receipt, storage, and distribution of pharmaceutical products, ensuring accurate inventory records and stock levels.
- Implemented and monitored inventory control systems, minimizing discrepancies and ensuring effective stock rotation.
- Identified opportunities to optimize warehouse processes, enhancing operational efficiency.
- Lead continuous improvement initiatives aimed at enhancing the quality and accuracy of warehouse operations.
- Prepared comprehensive reports for management review, offering insights and recommendations that enhanced warehouse operations and compliance.
Senior Officer Quality Compliance & Data Integrity
OBS Pakistan (Pvt.) Ltd
10.2017 - 04.2019
- Ensure adherence to local and international regulatory standards and guidelines, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Conduct regular audits and inspections of manufacturing processes and facilities to ensure compliance with quality standards and regulatory requirements.
- Developed and oversaw data management processes, ensuring documentation, storage, and retrieval complied with industry standards and regulations.
- Collaborated with cross-functional teams, including production, research & development (R&D), and regulatory affairs, to implement targeted process improvements.
- Reviewed, approved, and archived compliance documentation according to company policies and regulatory requirements.
Senior Compliance Officer
Macter International Limited
01.2017 - 10.2017
- Monitored and ensured adherence to local and international pharmaceutical regulations, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP).
- Contributed to development and implementation of compliance policies and procedures, aligning practices with industry standards and regulatory requirements.
- Conducted internal audits and compliance checks across all stages of the pharmaceutical manufacturing process to identify and mitigate potential risks.
- Reviewed and approved Standard Operating Procedures (SOPs), batch records, and quality control documentation to ensure compliance with regulatory standards.
- Participated in risk assessments related to the formulation, production, and distribution of pharmaceutical products, ensuring that all potential risks were documented and managed effectively.
- Compiled detailed reports on compliance activities, including audit findings, risk assessments, and CAPA outcomes, and presented insights to senior management.
- Acted as the primary point of contact for external audits and inspections, coordinating with auditors and regulatory agencies to facilitate smooth audit processes.
Officer Quality Assurance
NabiQasim Industries (Pvt.) Ltd.
07.2016 - 12.2016
- Ensured that all production and quality assurance activities complied with local and international regulatory requirements, including those set by the Therapeutic Goods Administration (TGA), FDA, and EMA.
- Led continuous improvement initiatives to enhance product quality, reduce defects, and improve operational efficiency.
- Collaborated with internal audit and inspection teams for manufacturing processes, ensuring adherence to quality standards and facilitating continuous compliance.
- Analyzed test results during the routine production floor operations to identify deviations from established standards and initiated corrective actions to address any non-conformances.
- Identified potential risks in the manufacturing process and reviewed preventive measures to mitigate those risks after implementation.
- Communicated with external auditors for compliance audits and facilitated the timely implementation of corrective actions.
- Prepared and presented quality assurance reports to senior management, emphasizing key performance indicators and actionable areas for improvement.
Education
Bachelor in Doctor of Pharmacy -
Zia Uddin University
Karachi07-2015
Skills
- Quality assurance
- Quality control
- ISO certification
- Regulatory compliance
- Audit management
- Risk management
- Process optimization
- Data integrity
Personal Information
- Father's Name: Asif Qadeer
- Date of Birth: 10/17/86
- Marital Status: Married
Timeline
Deputy Manager Quality (QA/QC)
Alpha Labs (Pvt) Ltd
11.2024 - Current
Technical Documentation Consultant
PharmArt Laboratory
07.2023 - 11.2024
Assistant Manager Quality Assurance
S.J. & G. Fazul Ellahie (Pvt) Ltd.
09.2020 - 06.2023
Senior Executive Warehouse
Maxitech Pharma Pvt Ltd.
05.2019 - 09.2020
Senior Officer Quality Compliance & Data Integrity
OBS Pakistan (Pvt.) Ltd
10.2017 - 04.2019
Senior Compliance Officer
Macter International Limited
01.2017 - 10.2017
Officer Quality Assurance
NabiQasim Industries (Pvt.) Ltd.
07.2016 - 12.2016
Bachelor in Doctor of Pharmacy -
Zia Uddin University