Quality Control Associate Manager
Resume:
Phone
***********@*****.***
A-2/3, Rufi Rose Petals, Gulzar-e-Hijri, Scheme-33, Sector15-A, Karachi, Pakistan
Address
MUHAMMAD
ZEESHAN CHOUDHRY
Associate Manager Quality Control
Awareness of PNAC policies and
Assuring the Validity of Result
Lead Assessor ISO/IEC 17025:2017
Evaluation of Measurement Uncertainty
Development and Implementation of
ISO 17025
About Me
I have been working as an Associate Manager
Quality Control and understand the key
concepts and principles of this job.
After working in Quality Control for over 12
years, I have developed extension knowledge
and expertise in the field and gained valuable
experience in various aspects while working with
some of the well-known national pharmaceutical
companies in Pakistan.
To ensure higher quality final product, my day-
to-day responsibilities encompass supervise raw
material, finished product and stability section
and Method Validation Section and carrying out
associated instrument testing.
Awareness / Certification
Achievement
Documentation related to
ISO 17025:2017
i
Lead role in ISO 17025:2017 project
Education
Master of Science.
(Applied chemistry)
University of Karachi - Year 2010
Bachelor of Science Hons.
(Applied Chemistry)
University of Karachi – Year 2008
Intermediate in Science
(pre-Engineering)
Govt. Gulshan Degree College –
Year 2004
Matriculation in Science
Federal Sec.School – Year 2002
command on instruments
High Performance Liquid
Chromatography (HPLC),
Fourier Transform Infrared
Radiation (FTIR),
Total Organic Compound (TOC),
Dissolution,
Disintegration Tester,
Friability tester,
Spectrophotometer,
Polarimeter,
Karl Fischer,
Potentiometer,
Liquid particle counter.
· ASSOCIATE MANAGER QUALITY CONTROL maxitech pharma pvt. Ltd June 2022 – june 2023
1. Responsible for analytical data review and to approve or reject as deems fit, the starting materials, bulk/finished products, trial batches and communication with costumers/service providers regarding all laboratory activities.
2. Testing of raw material up to finished products, sampling though instruments, apply wet chemistry and explain in compendious in-house methods. 3. Responsible for initial/continuing training and competence evaluation of Quality Control personnel to conduct laboratory activities as per annual departmental training plan and analyst qualification /competence evaluation program. Responsible for developing, training and mentoring of direct reports and other QC staff.
4. Conduct self-inspection of raw material, stability, finished good section. leads to ensure accuracy and integrity.
5. Quality Control Risk Assessment.
6. to review QC lab incoming supplies and materials up to date and QC overall environment such as, cleaning, washing, disposal of wastage etc and do the needful action as per instructions. 7. To check execution of plan that’s include method development, method validation / verification, instrument calibration.
8. Daily check lab activities to meet regulatory standard. (Strictly and vigilance to apply SOP’S and GMP’S in a routine day with continuity.)
9. To carry out tasks according to assigned time frames if the event that required more time as needed in case of any due date or other recurring problem. 10. To help colleague if they were unable to finish tasks on priority basis on time or had a good reason why they couldn't.
11. To Perform Root Cause Analysis for Failures Investigation, 12. Internal Audit Lead role on NME Audit (Sofosbuvir, Velpatasvir, Tenegliptin, Dexlansoprazole etc)
· ASSOCIATE MANAGER COMPLIANCE Platinum Pharma Pvt. Ltd June 2023 – Present
To cross verify daily assign job of analyst (raw material, stability, finished good section.). Randomly review analyst log book for QC compliance (raw material, stability, finished good section.).
To check execution of plan that’s include method development, method validation / verification.
To handle non-conformance, corrective action, risk management, deviation, complain or any other investigation.
Counter check certificate of analysis (raw material, stability, finished good section). Conduct self-inspection of raw material, stability, finished good section. To review Common Technical Document of product.
Counter check lab activities to meet regulatory standard. To review Quality control documents that’s include (standard test method, standard operating method, protocol, report etc.)
To supervise ISO/IEC 17025:2017 project.
Experience
· ASSISTANT MANAGER QC Indus Pharmaceutical Pvt. Ltd July 2018 – May 2022
Testing of raw material up to finished products,sampling though instruments,apply wet chemistry and explain in compendious in house methods.
Provide training, advice when need it and complete assistance to the laboratory staff regarding, different methods,tests etc
Do audit for any analytical given data and from the work books for procedures, leads to ensure accuracy and integrity.
Quality Control Risk Assessment.
Department Training Coordinator.
to maintain standard levels of lab supplies and materials up to date . To ensure maintenance of the instruments of the lab according to the SOP’S. Strictly and vigilance to apply SOP’S and GMP’S in a routine day with continuity. to maintain laboratory and its overall environment such as, cleaning,supplies,washing, disposal of wastage etc and do the needful action as per instructions. To do work as per the given assignments if required more time, any deadline,emergency, or any issues arises time to time bases.
To do the pending tasks on priority bases if the staff didn’t manage to complete in time or having solid reason for not done so.
To Perform Root Cause Analysis for Failures Investigation, Internal Audit
Lead role on NME Audit (Sofosbuvir, Velpatasvir, Tenegliptin, Dexlansoprazole etc)
· Q.C EXECUTIVE Indus Pharmaceutical Pvt. Ltd
March 2017 – June 2018.
Method Validation/ Verification
Instrument Performance Qualification
Quality Control Risk Assessment.
SOP, Standard Testing Method, Protocol, Reports.
Comparative Dissolution Profile.
Department Training Coordinator.
· Q.C EXECUTIVE Macter International.
May 2016 – March 2017.
Analysis of Finished Products and Stability.
To perform physical and chemical analysis of Inhaler. Method validation.
To Check the Performance of new HPLC Columns.
To post all analytical results on SAP and to update the changes in specification on SAP.
Handling/Calibration of Instruments.
· CHEMIST BOSCH Pharmaceutical Pvt. Ltd
March 2014 – April 2016.
Analysis of Semi-Finished products & Finished Products. Analysis of water.
Maintain all Q.C Documentation Records.
Contact this candidate