Hi, I’m
Zeeshan Anwar
Senior Manager Quality Control
Malir, Sindh,SD
Summary
Master’s in science with specialized in chemistry with more 13years experience in Quality control/Quality Department of different organizations Preparation of quality control documents & different SOPs. Responsible for the ISO 17025 accreditation of Drug Quality Control laboratory as well as ISO 9001 the quality Management system. Responsible for reviewing the results of Quality control compliance or non-compliance and ensure the validity of results. Involved in Quality Control, Quality Assurance and method validation. I am confident in leadership qualities. Having strong aptitude towards Quality /QC, Inspection tools, Quality Management and having an excellent Practical knowledge of Quality management review. Having an exposure and experience on testing equipment supplies, documentations, Record keeping, as well as production. Having a thorough practical knowledge of cGMP, GLP and validation work extensively involved in Quality operation documentation and write up of SOP and involved in the packaging material approval and its specifications. I have confidence in preparing in SOP writing their audit. I am involved in certification I was awarded a certificate of ISO 9001:2015 Quality Management system. Pharmaceutical organizations. Involved in preparing for ISO accreditation through preparing ISO documentation and write up of SOP as per international standard and involve in certification. As a team member I am actively involved in method validation and documentation of Quality management system. Extensively involved in cGMP and GLP audit. I am responsible of handling all Quality Control operation in Responsible to handle the external audits for accreditation and other delegations on quality aspects. Responsible for Quality and GMP inspection & Audit in different pharmaceutical organizations. At present I am working in National Growing pharmaceutical organization as Manager Quality Control.
Overview
20
years of professional experience
2003
years of post-secondary education
1
Certification
2
Languages
Work History
Le Mendoza Pharmaceutical Organization
Manager Quality control
02.2019 - Current
Job overview
- Implement/ Coordinate the plans and orders of the Plant Manager.
- Responsible for performance of quality operation and look after the Quality control & matters.
- Developed and lead the overall Quality objectives.
- Responsible for the implementation of an effective Quality Management Systems to ensure the site operates in compliance with Quality Manual including -but not limited to -
- Responsible for checking Day to quality assurance activities including in process control.
- Responsible to check that the operation of every section is doing properly according to the cGMP and company procedures and policy.
- Develop the Master validation plan and ensure its implementation.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Responsible To develop and administer the quality management system, quality assurance plans, integrated technical program, and facilitating change, execute quality plans, policies and procedures at all levels in the department according to the cGMP requirement.
- Established the validation of the equipment as well as validation of the methods.
- Established a strong Quality Control system on every step to minimize the chance of mistakes and to achieve the quality product.
- Responsible to ensure that every raw material should be first released from quality at earliest for smooth production operation.
- Responsible for ensuring that the quality operation is running according to the written procedure and checked by the Manager.
- Responsible to ensure that the in process (IPC) is according to the SOP and on every step as IPC is back bone of quality operation to produce the quality product.
- Responsible to ensure that any deviation happen must be mentioned in IPC report and rectify the deviation.
- Responsible to Prepare & check the Dossier of the product submitted for registration and if any descripcies occur rectify it accordingly.
- Review the results for quality control compliance or non-compliance and ensure the validity of results.
- Responsible to check that the QC operation of every section is doing properly according to the cGMP and company procedures and policy.
- Responsible for Developed the method validation.
- Developed the stability studies of the products.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Responsible To develop and administer quality control plans, integrated technical program, and facilitating change, execute quality plans, policies and procedures at all levels in the department according to the cGMP requirement.
- Established a strong Quality Control system on every step to minimize the chance of mistakes and to achieve the quality product.
- Responsible to ensure that every raw material should be first released from quality at earliest for smooth production operation.
- Responsible for ensuring that the quality operation is running according to the written procedure and checked by the Assistant Manager.
- Ensure to conduct various training and awareness sessions for workers and staff.
- Responsible & developed all standard operating procedures for the quality control.
- Responsible for ensuring that every step procedure is documented in production activities as well as in the quality operation.
- Cleaning procedures, equipment qualification and Process Simulation.
- I established and had experience developing the Master validation Plan for the Equipment, Process and others.
- Responsible for generating and leading the execution team, preparing validation protocols, IQ, OQ and PQ and preparing reports and summary report.
- Responsible & developed the OSS investigation and CAPA.
- Developed the specifications of the packaging material and its approval accordingly.
- Monitor the quality control operations of plants including sterile and non-sterile products to maintain the product quality.
- Developed the calibration programmed of every instrument and implement their calibration according to SOPs by external and Internal as well.
- Developed the validation program as well to the quality product and implement accordingly specially the sterile product.
- Developed and ensured the validation of instruments such as Autoclave and hot air sterilizers.
- Developed and implemented that sterile area should be monitor regularly according to written SOPs.
- Developed and implemented particle counts that should be monitored at each sterile manufacturing.
- Developed record keeping, log sheets and other documentation in quality control as well as in the production area.
- To be responsible and assure implementation of GMP related areas/functions in production, warehouse, Maintenance, Quality Control.
- Developed and implemented the SOP for self-inspection. Involved in self-inspection.
- Developed and implemented the Training SOP and conducted training sessions.
- Developed and implemented method validation as well as process validation.
- Developed the stability plan and conducted the stability studies as per plan or schedule.
- Developed the SOPs for QC and ensured its implementation.
- Responsible to ensure that every instrument is validated and calibrated accordingly to minimize the risk factor and accurate results as part of continuous improvement to maintain the quality of product.
- Conduct training on GMP, GSP, GDP.
National Pharmaceutical (Apex Pharmaceutical)
Manager Quality Control
07.2012 - 02.2019
Job overview
- Implement/ Coordinate the plans and orders of the Plant Manager.
- Responsible for performance of quality operation and look after, Quality control & Regulatory matters.
- Developed and lead the overall Quality objectives.
- Responsible for checking Day to quality assurance activities including in process control.
- Responsible to check that the operation of every section is doing properly according to the cGMP and company procedures and policy.
- Develop and execute operating plans that lead to the achievement of the site and product goals.
- Develop and maintain effective relationships with internal and external customers, regulators and other stakeholders.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Responsible To develop and administer the quality management system, quality assurance plans, integrated technical program, and facilitating change, execute quality plans, policies and procedures at all levels in the department according to the cGMP requirement.
- Responsible for overseeing the operation activities of production, quality as well as the warehouse according to the written procedures and cGMP.
- Responsible to execute the quality plan including quality control and assurance, Hence the product quality can be achieved.
- Established a strong Quality Assurance system on every step to minimize the chance of mistakes and to achieve the quality product.
- Responsible to ensure that every raw material should be first released from quality at earliest for smooth production operation.
- Responsible for ensuring that the quality operation is running according to the written procedure and checked by the Manager.
- Responsible to ensure that the in process (IPC) is according to the SOP and on every step as IPC is back bone of quality operation to produce the quality product.
- Responsible to ensure that any deviation happen must be mentioned in IPC report and rectify the deviation.
- To be responsible and assure implementation of GMP related areas/functions in production, warehouse, Responsible to process certifications from ISO and others.
- Perform Annual Product Review as per plan and SOP.
- To receive communicate and investigate the complaint as per SOP.
- To develop and implement the self-inspection and perform as per SOP.
- Responsible for looking after the registration & and renewal of the registration of the product with regulatory department.
- Responsible to check the Dossier of the product submitted for domestic and if any descripcies occurs rectify it accordingly.
- Responsible to ensure that the quality control analysis is done according to the recognized method as per USP/BP.
- Developed and reviewed the product specification according to USP/BP/Innovators required by DRAP to avoid misbranding.
- Developed the BMR and reviewed and revised the SOPs accordingly.
- Review the results for quality control compliance or non-compliance and ensure the validity of results.
- Developed and established the inventory system in the warehouse according to policies & procedures.
- Responsible & Developed the Quality Manual and all standard operating procedures for the production as well as quality operation.
- Developed the following documents
- 1. OOS
- 2. Quality Risk management
- 3. Self-Inspection
- 4. Stability plan
- 5. Temperature & Humidity Sops & records
- 6. Training SOP
- 7. Trend analysis SOP
- 8. Test method SOP
- 9. Validation SOP
- 10. Vendor’s Audit
- 11. Microbiological SOPs
- 12. Receiving & handling of raw material
- 13. Retest of raw material
- 14. Equipment qualification protocol
- 15. Master validation SOPs
- 16. Internal Audit check list
- 17. Calibration SOP
- Responsible for generating and leading the execution team, preparing validation protocols, IQ, OQ and PQ and preparing reports and summary reports.
- Responsible & developed the OSS investigation.
- Developed the specifications of the packaging material and its approval accordingly.
- Monitor the quality control/assurance and operations of plants including Cephalosporin and non-sterile products to maintain the product quality.
- Directed activities of quality control, registration and formulation development departments.
- Developed and ensured the validation of instruments.
- Developed and implemented the particle count should be monitor at Cephalosporin manufacturing.
- Developed the record keeping, log sheets and other documentation in quality control manufacturing.
- Developed and implemented the SOP for self-inspection. Involved in self-inspection.
Helix Pharmaceutical
Sr.Quality control Analyst
12.2005 - 03.2011
Job overview
- Developed and lead the overall Quality strategy and Quality objectives. Maintain the responsibilities for the planning, implementation and control of quality to ensure compliance with Quality Manual requirements.
- Review the results for quality control compliance or non-compliance and ensure the validity of results.
- Establish and actively maintain internal/external customer service relations in accordance with corporate shared values. Work with corporate and/or industry groups to share and implement best practices.
- Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and MOH Corporate Guidelines when auditing industries.
- Document statement of quality policy and quality objectives.
- Establishing the quality manual.
- Control the documents and records required by the quality management system by defining the ways of identification, storage, protection, retrieval, retention time and disposition.
- Ensure to control the internal and external communications.
- Ensure to control the purchasing of materials and products related to project.
- Ensure control of monitoring and measuring devices needed to provide evidence of product conformity.
- Ensure to identify and control nonconforming products and prevent its unintended use or delivery.
- Having laboratory analytical experience as well.
- Ensure corrective actions to eliminate the cause of nonconformities in order to prevent recurrence.
- Ensure to determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.
- Member of Management review committee.
- Responsible for the revision of SOPs and updates.
- Responsible for establishing the calibration of instruments to get the proper results.
- Quality Assurance (Methods)
- Method validations for Accreditation
- Participating in the External Proficiency scheme for pharmaceutical products & water
- Responsible for writing of Standard Operating Procedures (SOPs)
- Ability to work on Quality Management System the requirement of ISO 17025.
- Having an ability to motivate and energize the team for quality improvement through good interpersonal and leadership skills.
- Knowledge of Quality management System and able to handle the External auditors.
- Updating the standard according to the international methods or recognized methods
- Housekeeping and quality standard.
- Established and having experience to develop the Master validation Plan for the Equipment, Process and others.
- Worked with regulatory affairs in MOH of United Arab Emirates, hence having an experience in regulatory affairs and preparing the dossiers of products for export as well as local.
- Working in Drug Quality Control so having an exposure in Quality Control As well.
- Having in-depth knowledge of cGMP and GLP as well.
- Established the Method validation SOP.
- Established the SOP for Operation, maintenance and calibration of equipment’s.
- Excellent ability to give presentations on any topic.
- Excellent computer literate (Microsoft Office) with demonstrated skills in the use of word processing, spreadsheets & others.
Education
University of Karachi
M.Sc. from Chemistry
Skills
Ability to work on Quality Management System the requirement of ISO 17025
Having an ability to motivate and energize the team for quality improvement through good interpersonal and leadership skills
Knowledge of Quality management System and able to handle the External auditors
Updating the standard according to the international methods or recognized methods
Housekeeping and quality standard
Established and having experience to develop the Master validation Plan for the Equipment, Process and others
Worked with regulatory affairs in MOH of United Arab Emirates, hence having an experience in regulatory affairs and preparing the dossiers of products for export as well as local
Certification
ISO 9001:2015 Quality management system
Training
- Completed a training of CTD Dossier preparation
- ISO 9001:2015 Quality management system
- Course of Microsoft Excel XP, Word XP and Power Point XP. (MOUS)
PRESENTATIONS/TRAINING
- Presentation was given on “validation”
- Presentation was given on “cGMP.”
- Presentation was given on “GSP.”
- Presentation was given on “GLP”
- Presentation was given on “GDP.”
Affiliations
HEJ RESEARCH INSTITUTE OF CHEMISTRY
Timeline
Manager Quality control
Le Mendoza Pharmaceutical Organization
02.2019 - Current
Manager Quality Control
National Pharmaceutical (Apex Pharmaceutical)
07.2012 - 02.2019
Sr.Quality control Analyst
Helix Pharmaceutical
12.2005 - 03.2011
University of Karachi
M.Sc. from Chemistry
01.2003