Hameed Khan
Doctor Of Pharmacy (Pharm-D) + MBA
House No. 16/46 Landhi Dawood Chowrangi Karachi
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
15
15
years of professional experience
11
11
years of post-secondary education
1
1
Certificate
4
4
Languages
Work History
Sr. Manager QMS
Pharmatec Pakistan Limited
2023.05 - Current
- Developed and implemented new filing systems to improve organizational efficiency and productivity.
- Identified cost improvement changes and cost savings plans to increase company savings.
- Implemented and developed operational standards, policies and procedures.
- Consolidated vendors and renegotiated contracts to optimize costs.
- Leading overall QMS functions including Change control, Deviation, Investigation, CAPA, Quality Risk Management,Quality management Review, complaint handling and associated functions
- Manage Compliance & Enforcement activity including In-Process Control of Product Manufactured, Batch Release, Annual Product Quality Review, Internal Audits and Vendor Qualification
- Responsible to ensure that internal audit has been properly managed involving team of auditors from different departments
- Responsible for managing all vendor qualification program including any contracting / subcontracting manufacturing and testing program
- Ensure that all External Audits managed and all observations properly communicated in timely manner
- Responsible for approval for execution of Validation Master File and compliance of associated functions, including, Process validation, cleaning validation, Hold time Studies and Qualification activities along with calibration activities
- Responsible to monitor QA Retention sample room, their control and archiving process
- Maintain discipline and order in department and ensure all company rules, procedures and instruction of department head are being implemented and followed Ensure that market returned goods (expired / damaged) and industrial waste are being disposed of as per approved procedure
- Participate in Quality Meetings and provide review about quality issues, objectives and appropriate suggestion.
- Provided strong leadership to enhance team productivity and morale.
Manager QMS
Aspin Pharma (Pvt) LTD
2020.08 - 2023.05
- Leading the overall QMS functions including Change control, Deviation, Investigation, CAPA, Quality Risk Management,Quality management Review, complaint handling and associated functions
- Manage Compliance & Enforcement activity including In-Process Control of Product Manufactured, Batch Release, Annual Product Quality Review, Internal Audits and Vendor Qualification
- Responsible to ensure that internal audit has been properly managed involving a team of auditors from different departments
- Responsible for managing all vendor qualification program including any contracting / subcontracting manufacturing and testing program
- Ensure that all the External Audits managed and all the observations properly communicated in a timely manner
- Responsible for the approval for the execution of Validation Master File and compliance of associated functions, including, Process validation, cleaning validation, Hold time Studies and Qualification activities along with calibration activities
- Responsible to monitor QA Retention sample room, their control and archiving process.
Assistant Manager QA
Getz Pharma (Pvt) Limited
2018.01 - 2020.08
- Leading the Audit team with maintaining GMP standard through self-inspection, GMP inspection and Internal Audit
- Managing the CAPA & Deviation Management System and on time closing on SAP
- Leading the team of In Process Control for OSD area, liquid area, semi solid area and Sterile area
- Responsible to ensure compliance of GMP in overall OSD Manufacturing, Sterile areas,DPS, DPI and Packaging areas through line clearance and in process monitoring
- Participate in WHO Audits (2015, 2017 & 2020); PIC/S (2015 & 2018), ISO 9001:2015 & EMS 14001: 2015 transition Audit, and DRAP audit (2020)
- Involve in various QMS functions like Change control, investigation, Risk assessment, PQR, complaint handling with report preparation and closing responsible for batch record auditing activities.
Sr. Executive QA
Getz Pharma (Pvt) Limited
2015.01 - 2017.01
- Assured consistent quality of production by implementing and enforcing automated practice systems.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
Executive QA
Getz Pharma (Pvt) Limited
2014.09 - 2014.12
- Reported production malfunctions to managers and production supervisors.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
Sr. Officer QA
Getz Pharma (Pvt) Limited
- Monitoring quality, compliance and productivity.
- Held monthly meetings to create business plans and workshops to drive successful business.
- Implemented and developed operational standards, policies and procedures.
QA Inspector
Nexus Pharmaceuticals (Pvt) Limited
2012.03 - 2014.09
- Line clearance an in process checks in OSD Manufacturing areas, Semi Solid Areas, Sterile Area and Packaging areas, BMR and BPR auditing and SOP's review.
- Performed visual inspections and non-destructive tests where appropriate.
- Evaluated components and final products against quality standards and manufacturing specifications.
- Communicated with production team members about quality issues.
- Trained and mentored junior inspection staff and interns to apply best practices and comply with quality control guidelines and regulations.
QA/QC Officer
C.K.D Pharmaceuticals (Pvt) Limited
2012.05 - 2014.03
- Line clearance an in process checks in Manufacturing and Packaging department, sampling of raw and packaging materials, BMR and BPR auditing and SOP's review
- Sampling and testing of raw materials
- Preparation of analytical method validation protocols and reports
Production Control Inspector
Abbott Laboratories
2009.01 - 2012.01
- Prepared reports detailing findings of inspections, investigations, and tests.
- Investigated complaints to remedy buildings, equipment and safety issues.
- Maintained up-to-date inspection and audit records for improved reporting and analysis.
- Educated staff on safety and quality improvement strategies to uplift standards.
Education
MBA - Pharmaceutical Management
Salim Habib University
Karachi, SD 2020.01 - 2022.01
Doctor of Pharmacy (Pharm-D) - Pharmaceutics
University of Sindh Jamshoro
Jamshoro, SD 2005.01 - 2010.01
Intermediate - Science
Model College
Hyderabad, SD 2002.01 - 2004.01
Metric - Science group
Jamia Islamia High School
Hyderabad, SD 2000.01 - 2002.01
Skills
Team Player
undefinedTimeline
Sr. Manager QMS
Pharmatec Pakistan Limited
2023.05 - Current
Manager QMS
Aspin Pharma (Pvt) LTD
2020.08 - 2023.05
MBA - Pharmaceutical Management
Salim Habib University
2020.01 - 2022.01
Assistant Manager QA
Getz Pharma (Pvt) Limited
2018.01 - 2020.08
ISO 9001:2015 QMS Lead Auditor
2017-09
Sr. Executive QA
Getz Pharma (Pvt) Limited
2015.01 - 2017.01
Executive QA
Getz Pharma (Pvt) Limited
2014.09 - 2014.12
QA/QC Officer
C.K.D Pharmaceuticals (Pvt) Limited
2012.05 - 2014.03
QA Inspector
Nexus Pharmaceuticals (Pvt) Limited
2012.03 - 2014.09
Production Control Inspector
Abbott Laboratories
2009.01 - 2012.01
Doctor of Pharmacy (Pharm-D) - Pharmaceutics
University of Sindh Jamshoro
2005.01 - 2010.01
Intermediate - Science
Model College
2002.01 - 2004.01
Metric - Science group
Jamia Islamia High School
2000.01 - 2002.01
Sr. Officer QA
Getz Pharma (Pvt) Limited
Certification
ISO 9001:2015 QMS Lead Auditor
Accomplishments
WHO Pre-Qualification Certificate: Successfully obtained the WHO Pre-Qualification Certificate, demonstrating compliance with global pharmaceutical quality standards and recognition for producing high-quality pharmaceutical products.
PIC/s Certification: Attained PIC/s (Pharmaceutical Inspection Co-operation Scheme) Certification, underscoring adherence to internationally recognized standards for pharmaceutical manufacturing and regulatory compliance.
Medical Devices License from DRAP: Secured the Medical Devices License from the Drug Regulatory Authority of Pakistan (DRAP), ensuring the legal authorization to manufacture and market medical devices in Pakistan.
Manufacturing Drug License Renewal from DRAP: Accomplished the renewal of the Manufacturing Drug License from DRAP, demonstrating consistent compliance with pharmaceutical manufacturing regulations and quality standards.
GMP Inspection from DRAP: Successfully passed a Good Manufacturing Practices (GMP) inspection conducted by DRAP, affirming adherence to high-quality standards in pharmaceutical manufacturing.
Successful accomplishment CMO Project by Audit of Various Pharmaceutical Firms: Efficiently executed Contract Manufacturing Organization (CMO) projects by conducting comprehensive audits of various pharmaceutical firms, ensuring the successful outsourcing of pharmaceutical production while maintaining quality and compliance.
Vendor Qualification of Various Raw Material and Packaging Suppliers: Proficiently qualified and established relationships with diverse raw material and packaging suppliers, ensuring a reliable and compliant supply chain for pharmaceutical manufacturing operations.
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