Waqas Ishaq Muhammad Ishaq
Profile URL Available.
Assistant Manager Quality Control
Don Valley pharmaceuticals Pvt.Ltd
MSc Chemistry
University of Engineering and Technology (UET) Lahore
Summary
SUMMARY:
Analytical Chemist Professional with a Master Degree in Applied Chemistry having 6 years of diverse experience in Laboratory, Production, Quality control & Quality Assurance, Regulatory affairs and manufacturing facilities of Don Valley Pharmaceutical, Cunningham Pharmaceutical & CSH Pharmaceutical; with a proven track record of sustained performance, delivering challenging & complex projects as well as managing & leading large teams
Experience
Assistant Manager Quality Control - Don Valley pharmaceuticals Pvt.Ltd
2018 - Present
Don Valley Pharmaceuticals (April 2018 Till date)
Assistant Manager QC/QA
Perform and record the Analytical Test Method validation of APIs (Active pharmaceutical Ingredients) Raw materials and different products on Consecutive three batches.
Preparation of User Requirement Specifications, Analytical Equipments Validation including preparation of Design, Installation & Operational Qualification Protocols, Performance Qualification Protocols and their final reports.
Preparation and coordination in Process Validation Protocol and final reports of different pharmaceutical products.
Preparation and coordination in Utilities Validation including HVAC system, RO water Plant and Air Compressor.
Preparation of Validation Report and validation summary Report, validation Master plan. (VMP) and Site validation Master plan (SVMP).
Ensure the stability studies are carrying on according to planned schedule.
Maintain the record of all reference standards, working standards, chemicals and reagents used in chemical testing of products.
Preparation of all documents including general Sops, product specifications, raw and packaging material Specifications.
Educate, Encourage, and Motivate the Subordinates; Ensure Compliance by giving Training on GMP guidelines, ICH Guidelines and WHO Guidelines.
Taking active part in Method Validation, Process Validation and equipment Validation.
Perform Chemical and Physical Tests as Per Lab Authorization, SOPs and Work Instructions.
Monitor and Implement The Quality Management Systems Such As ISO 9001, ISO/IEC 17025 and ISO 13485.Having experience in cGMPs and FDA regulations.
Yield Reconciliation of finished products, raw and packaging material from batch start to finished.
Development & evaluation of packaging components specification.
Assay & checking of all Raw Materials and all Products according to standard specifications.
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Assistant Manager Quality Control - Cunningham Pharmaceutical Pvt.Ltd
2017 - 2018
Cunningham Pharmaceutical (April 2017 April 2018)
Assistant Quality control Manager
Validation of Analytical Test methods.
Process monitoring in Dry Syrup, Tablet and Capsule vial ampoule & infusion manufacturing area.
Yield Reconciliation.
Development & evaluation of packaging components specification.
Assay & checking of all Raw Materials according to specification.
Assay & checking of all Products as per specification.
Compilation of Batch history records.
To assure all GMP & GLP standards.
To handle claims from market.
Create, Revise and Implementation sops to ensure GMP & GLP.
To ensure equipments and facilities are maintained in high state of repair and cleanliness.
To ensure that authorized producer for the operation and calibration of all the equipments are in place of the calibration record is being properly maintain.
To coordinate and communicate with other departments.
To monitor microbiology section.
Main Instruments: Assay Testing of APIs, Raw Material general, Finished Products, Stability samples by Utilizing Laboratory Equipment Including High Performance Liquid Chromatography Agilent 1100 series with Chemstation software HPLC Agilent 1260 infinity VWR detector, AA-6200 Atomic Absorption Spectrophotometer, Karl Fischer instruments, FTIR Bruker, UV-Spectrophotometer and Dissolution Apparatus etc.
Quality control officer - CSH Pharmaceuticals Pvt.Ltd
2014 - 2017
CSH Pharmaceuticals (Pvt.) Ltd (June 2014 April 2017)
QUALITY OFFICER
Conduction of Self Inspection and preparation of finding report and CAPA.
Conduction of Audit and its CAPA.
Effectively deliver coaching and feedback to team members to support compliance and efficiency.
Identify training gaps in team, and ensuring adherence to all Training programs.
Ensure all tasks are completed as per the relevant SOPs, identifying and addressing any non-compliant operation.
Implementation of Good Lab Practices (GLPs).
Handling of Out of Specification/Atypical Results, deviation, changes control and customer complaint.
Coordination in preparation of User Requirement Specification.
Coordination in Validation of Analytical Test methods.
Coordination in Analytical Equipments Validation.
Coordination in preparation of Design, Installation & Operational Qualification Protocols, Performance Qualification Protocols, Process Validation Protocol.
Coordination in Preparation of Validation Report and validation summary Report.
Coordination in Preparation of validation Master plan. (VMP).
Coordination in Preparation of Site validation Master plan (SVMP).
Preparation of Stability Protocols, stability schedule, Stability Reports and Stability Record.
Maintenance of stability sample reconciliation and stability chambers.
To ensure both in house and external calibrations are being carried out according to defined calibration schedules.
Checking calibration status of equipments, Lab instruments, Measuring devices and utilities. Also managing records and vender activities.
Preparation of Annual product review.
Preparation and reviewing of SOPs.
Complier and Reviewer of batch documents for Finished Product Release.
Monitoring through Trend Charting.
Checking and ensure the Bill of material of Different newly Developed Products.
Involve in the method development and process development.
Perform trail to set the required product specification.
Analytical Test methods development and verification from international standards.
Qualification of Equipments involved in process, in testing.
Preparation of general laboratory solution and standardization.
Operation of Agilent HPLC 1100 series with ChemStation software, UV-Visible spectrophotometer. , Shimadzu Karl Fischer, Polarimeter Polax 2L, Disintegration apparatus, Dissolution apparatus, pH meter, Conductivity meter, Karl Fischer Mettler Toledo.
Operation of melting point apparatus. FTIR IR-Affinity-1, Ultrasonic batch Elmasonic E60H, Hot Plate (Magnetic Stirrer), Particle size analyzer, Auto-friability Tester, Automated tablet testing instrument.
Release and Preparation of Packaging Material Report.
Handling of Art Work.
Honours And Awards
No Timeline To Show.