SAP QM Module
Syed Muhammad Danish
Quality Management And GMP Professional
Jeddah,Makkah
Summary
Pharmaceutical Quality Management Professional with 20 years experience and proficient in all QA and QC operations, cGMP and international regulations. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Expertise in business process mapping, QM Module & its integration with other business modules in ERP SAP.
Overview
21
21
years of professional experience
4
4
years of post-secondary education
4
4
Certifications
Work History
ASSOCIATE MANAGER QA
Jamjoom Pharma
Jeddah
2020.01 - Current
- Lead International Projects (CMO, New Sites)
- Established Quality Agreements
- Lead RSO Projects
- Technical Review and approval of documents for regulatory agencies
- Alternate source development for starting materials
- Manage Site Change Control
- Product Failures and Complaints Investigation
- Variation approvals from SFDA and other regulatory agencies
- Gap Assessments against regulatory requirements
- Product Recalls Handling
- Manage Artwork Control
ASSISTANT MANAGER QUALITY ASSURANCE
Jamjoom Pharma
Jeddah
2016.01 - 2019.12
- Compliance fulfillment in factory premises
- Site deviation handling and CAPA Management
JUNIOR MANAGER QUALITY ASSURANCE
Jamjoom Pharma
Jeddah
2013.02 - 2015.12
- Product Quality review
- Out of Specification Handling
ASSISTANT MANAGER QUALITY ASSURANCE
Hilton Pharma
Karachi
2008.10 - 2013.01
- Responsible for Batch Release
- Compliance fulfillment of manufacturing Plant
- Handling of Deviations and CAPA Management
- Change Control Management,
SENIOR OFFICER QUALITY CONTROL
Barrett Hodgson Pvt Ltd
Karachi
2004.05 - 2009.09
- Raw material, finished product & stability testing
- Analytical Method Validation
- Specification and Test Method writing
- Equipment Calibration
QUALITY CONTROL INSPECTOR
Macter International
Karachi
2003.04 - 2004.05
- In process of Sterile and non-sterile areas
- Sampling of Raw Materials, Packaging Materials and FG
- Area Monitoring of Sterile area
QUALITY CONTROL ANALYST
Parke-Davis
Karachi
2002.10 - 2003.04
- Raw material testing
Education
Master of Science - Applied Chemistry
UNIVERSITY oF KARACHI
Karachi, Pakistan 2002.01 - 2002.12
Bachelor of Science - Applied Chemistry
University of Karachi
Karachi, Pakistan 1999.01 - 2001.12
Skills
Pharmaceutical Quality System
Compliance & Regulatory Requirements
[SAP] QM Module
Project Management
Quality Agreement/ CMA
KPI Development
Quality Control
Accomplishments
- SAP QM Module (Mapping, UAT & Implementation)
- Bench marking with McKinsey
- Cost saving and RSO projects
- Business continuity plan after outbreak of COVID 19
- Project with CMO
Software
MS Project
Certification
Foundations of GMP (10 Modules)
Timeline
Foundations of GMP (10 Modules)
2022-10
Decision Making Strategies
2021-10
Statistic foundation
2021-10
Management Foundation
2021-10
ASSOCIATE MANAGER QA
Jamjoom Pharma
2020.01 - Current
ASSISTANT MANAGER QUALITY ASSURANCE
Jamjoom Pharma
2016.01 - 2019.12
JUNIOR MANAGER QUALITY ASSURANCE
Jamjoom Pharma
2013.02 - 2015.12
ASSISTANT MANAGER QUALITY ASSURANCE
Hilton Pharma
2008.10 - 2013.01
SENIOR OFFICER QUALITY CONTROL
Barrett Hodgson Pvt Ltd
2004.05 - 2009.09
QUALITY CONTROL INSPECTOR
Macter International
2003.04 - 2004.05
QUALITY CONTROL ANALYST
Parke-Davis
2002.10 - 2003.04
Master of Science - Applied Chemistry
UNIVERSITY oF KARACHI
2002.01 - 2002.12
Bachelor of Science - Applied Chemistry
University of Karachi
1999.01 - 2001.12