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Manager Data

Location:
Woodstock, Western Cape, 7915, South Africa
Posted:
January 03, 2020

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Resume:

Current Address:

MSA House, *** Oak Avenue Ferndale Randburg, Johannesburg, Gauteng South Africa.

Permanent Address:

House No. 32 Gulshan Umar Colony New Green Town Lahore, Pakistan.

Contact No.

+277********

+923*********

Email: ada7av@r.postjobfree.com

MUHAMMAD ZIAQAT SHAHZAD

OBJECTIVE:

Seeking a challenging and responsible position in a well-known and reputable organization, where my expertise, professional skills, experience, abilities and energies in Liquid Chromatography, method development, validation and other analytical techniques will be utilized to their full potential.

To achieve success with honesty and intentional efforts towards my profession and to sharpen my skills, technically and professionally along with the growth of the organization.

To serve humanity by devotion, hardworking and sincerity to profession.

Professional Experience: 12 YEARS

QUALIFICATIONS SUMMARY:

Masters in Chemistry with 12 years of industrial experience covering Pharmaceutical and Bio-informatics. Hands on experience in Development and Validation of Analytical Methods for Drug Substances, Drug Products and Method Transfers.

Strong operational knowledge of analytical instrumentation like HPLC, UPLC, GC, FT-IR,

AAS, UV-VIS Spectrophotometer, Karl Fisher, Dissolution, TLC, Coulometric, AMT, OOS/OOT investigation and auto titrations and data stations required, USP and NF standards.

Expert in Method Development and Validation by using HPLC’S (UV/PDA Detector), UPLC’S (PDA/e£PDA Detector) and UV/Vis, Spectrophotometer.

Very good knowledge and technical skills in troubleshooting and calibration of commonly used analytical instruments.

Experience in writing SOP’s, Method Validation protocols and reports.

Familiar with compliance requirements within cGMP, safety and regularity environments.

Experience with training chemists on analytical test methods.

Experience in GMP and GLP environment following ICH guidelines.

Several years of experience performing method development, method validations and method transfers.

Employment History:

Assistant Manager Quality Control

Pharmaspec Consulting Laboratories Johannesburg (South Africa)

March 2014 to Present : Responsibilities and Duties:

Responsible for managing and setting the direction of the QC Laboratory operations in a cGMP environment. Main responsibility is to assure the reliability of all data generated by the Quality Control Laboratories and the safety of all personnel.

Responsible for the daily running of the Department, overseeing the day to day activities with specific responsibility for organising of work in the area & training.

Provide leadership for various operational tasks within laboratory including use & maintenance of modern analytical instrumentation such as UPLC, HPLC, GC/MS, LC/MS, UV, NMR, GC, FT-IR, and AA.

To Supervise, manage & monitor all lab department activities, plan & prepare lab services & procedures.

Establish, execute, review & evaluate lab procedure, policies, control documents records.

Troubleshooting and scheduling the utilization of the lab equipments.

Create & review Standard Operating Procedures & approval of lab documents & reports.

Independently develop & suitability validate analytical test methods & perform equipment calibrations and validations.

Leading investigations including deviations, out of specifications (OOS), out of trend (OOT), customer complaints, identifying the root cause.

Supporting the audit programm, analyze data, document results, write reports & maintain lab equipment qualification, calibration & validation status.

Oversee inspections and testing of products and materials, and produce reports on the results.

Train, supervise, and evaluate quality control team members.

Schedule and coordinate preparations for product inspections and testing.

Work to resolve noncompliance issues with materials or final products.

Support of timely analytical testing required for the Stability Program.

Leading investigations including deviations, out of specifications (OOS), out of trend (OOT) customer complaints, identifying root causes.

Responsible for Environmental, Health, and Safety compliance.

Communicate with Manufacturing, Facilities, Quality Assurance and other external departments on analytical operational issues.

Serve as analytical QC reviewer of test data packets for product release, stability, validation protocols, special test requests and special studies.

Troubleshooting and scheduling the utilization and perform calibration & validations of HPLC’s, UPLC’s, AAS, GC and other laboratory instruments as per SOP and interpreted data into the sheets and keeping records of calibrations.

Represent QC laboratory in a technical expert capacity on analytical methods when required. Understanding of ICH/FDA guidance for Impurities.

Independently develop, validate, and routinely execute test methods for Drug Substances and Drug Products as required.

Participating in self inspections and regulatory inspections.

Responsible for quality and regulatory review of technical and quality documents including: batch records, product specifications, repacking specifications, validation reports (IQ/OQ/PQ), deviations and investigations.

Developed and validated analytical test procedures and Performed test method transfers.

Create Laboratory Reports according to the SOP. Ensure that Analysts complete tasks allocated to them within a specified time frame. Coordinating the flow of work between the lab and the manager.

Conduct literature searches and stay up to date with new technologies/applications and focus on advancements to improve/benefit the department.

Co-ordinates, develops and manages Validation systems (i.e. Process Validation, Cleaning Validation, Packaging Validation, Equipment Qualification, Facility Qualification, Utilities Qualification, Computer Validation and Bulk Holding Studies) and procedures to ensure compliance with all regulatory and corporate requirements in manufacturing, packaging and testing of the Company products. Ensures the Validation Master Plan and all Standard Operating Procedures relating to Validation are reviewed and maintained to be current. Validation protocols are compiled and executed timeously.

Laboratory Supervisor

Pharmaspec Consulting Laboratories Johannesburg (South Africa)

March 2012 to February 2014:

To ensure and monitor all analysis are always performed in accordance with instructions and to the methods pertaining to the analysis. To supervise the duties of laboratory staff and to assist them where necessary and to train the analysts. Assist in checking analytical data and reports.

Supervision of Laboratory Analysts.

Assistance with the preparation and resolution of Quality Technical Agreements (QTAs)

Supporting the audit programme by participating in audits of GMP related systems, processes and facilities.

Tested physical and chemical characteristics of new active pharmaceutical ingredients and drug products.

Review of quality metrics and identification of quality issues, trends, encouraging improvement initiatives and presenting to senior management.

Experience in quality administered systems including Track-Wise QMS, SAP and LIMS.

Maintaining an effective quality system for the reception, quarantine, storage, release and distribution of products throughout the supply chain including the analysis of temperature logged data with regards to cool products.

Trained junior team members on analytical techniques and GMP/GLP procedures as per controlled SOPs.

Analyze data, document results, maintain laboratory notebook according to cGMP and internal guidelines. Preparing analytical methods of development and validation protocols and test reports.

Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.

Provides support for ordering and maintaining inventory of laboratory materials and equipment.

Holds advanced knowledge of liquid chromatography and Chemistry for the purpose of degradation, Decomposition and Related substances identification, Characterization and control analytical impurities and reference standards.

Confer directly with client for method review and updates, reporting data, and OOS and OOT alerts and investigations.

Performing analytical chemistry assays based on new and existing methodologies, operating analytical instrumentation such as HPLC, UPLC, GC, AAS, FTIR, UV-Visible Spectrophotometer, Titrator, Particle Size Analyzer, developing, establishing, and validating analytical testing methodology used to control raw materials, production intermediates, and final products, writing technical reports to document analytical methods and transferring documented analytical methods to the QC department.

Conducts and writes laboratory investigations using the appropriate Root Cause Analysis tools.

Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document.

Extensive knowledge of and experience in drug development and working in accordance with GLP and GMP requirements.

Disposal of hazardous waste according to environmental regulations and company/ departmental procedures.

Conducted calibration of laboratory instruments as per schedule and maintaining calibration sheets.

Experience in running Waters 2695, 2690 (Alliance) HPLC’s and UHPLC’s Acquity I-Class and H-Class with Empower 2 and 3 software’s and 2487 Dual λ absorbance, 996, 2996 PDA and RI 2414 Detectors.

Pharmaspec Consulting Laboratory involved in testing of pharmaceutical products come from different renowned and largest companies like Aspen Pharmacare, Adcock Ingram Pharma, Austell Laboratories, Be-tabs Pharmaceuticals, Sun Pharma, Ranbaxy, Pharmachem Pharmaceutical (Dezzo), Arrow, Watson, Hersol Pharmaceutical, Bayer, Mylan, Akacia Healthcare, Accord Healthcare & Johnson & Johnson etc.,

Senior QA/QC Chemist (Siza International Lahore Pakistan)

July 2010 to Feb. 2012:

Setting up and conducting chemical experiments, tests, and analyses using techniques such as chromatography, spectroscopy, physical and chemical separation techniques, and microscopy using all major analytical instruments for completion of preliminary analyses and interpretation of test results., like, HPLC, GC, FTIR, TLC, UV Vis, MS, pH testing, instrument calibration, centrifugation and volumetric/colometric titrations.

Analysis of pharmaceutical finished, in-process products, like injections, infusion, syrups, tablets, capsules, suspensions samples. Re-analysis of failing products by other analysts and producing final analytical repots of failing product. Review of analysis methods. Preparation of lab for audits and implementation of GLP.

Calibration of instruments like pH meter, Balances, Conductivity meter, Polarimeter, FTIR, UV Spectrophotometer, viscometer. Development and implementation of standard operating procedures in the form of official documents and training.

Handling and preparation of primary & secondary standards Analysis of customer complaint samples. Analysis of Stability samples according to applicant requirements and tabulating the stability data.

Writing test protocols, performing technical evaluations and submitting test results to support technical assessment reports used to justify the use of selected materials Providing technical support and assistance to chemists and engineers for the assessment, development, and implementation of solutions for complex problems arising during quality assessment Working side by side with the Research and Development team to develop and adapt laboratory procedures to achieve the best results, interpret data, and devise solutions to complex problems.

To test different samples of Raw materials.

Complete testing of distilled water and analysis of sample during treatment of water plant.

To monitor in process activities of production department and inspection of production areas to make sure working conditions complies with cGMP and GMP.

To make arrangement of internal calibration and maintain its record.

To write operating procedures of different instruments & testing methods (SOP’s & SOI’s) for Raw materials and for different Products.

Stability Studies.

Experienced with HPLC, UV-VIS Spectrophotometer, Dissolution, Karl Fisher, Coulometric and volumetric titrations etc.

To perform duties in another section of QC as assigned by QC Manager.

QA/QC Analytical Chemist

Medipak Pharma Limited Lahore Pakistan

July 2007 to July 2010:

Performed testing of raw materials using the following techniques: Titration by Karl Fischer, Assay by Titration, ID by FT-IR, TLC, UV/Vis, Determination of Water Conductivity, Wet Chemistry: Heavy Metals, Residue on Ignition, Loss on Drying, pH, Melting Point, Arsenic, Specific Gravity, Specific Rotation, etc., Process Validation- Bulk and Tap Density, Particle Size, Finished Product- Hardness, Disintegration time, Dissolution, Thickness, Diameter, Friability, Refractive Index and all types of titrations including complexmetric, agentometric, volumetric and colometric titrations for determination of active compounds in pharmaceutical products.

Other Duties: Lab Safety Officer; responsible for tracking of samples released and pending; responsible for maintaining raw material data for protocols.

Adept in the use of various instruments and analytical techniques such as Identification, Physical and Chemical Testing of Raw Materials and Active Compounds used for the Preparation of Drugs.

Determination of %age composition of active components in the Drugs (SDF, Eye Drops IV & Syrups).

Review work generated by analytical and QC when required ensuring all procedures are followed.

To test different samples and then keeping records and making certificate of analysis according to FDA rules and regulations.

Tested physical and chemical characteristics of new active pharmaceutical ingredients and drug products.

Worked in a cGMP laboratory with strong emphasis on microscopy, spectroscopy and data handling.

Other responsibilities included: Analyzing samples from various sources to provide information on compounds or quantities of compounds present; using analytical techniques and instrumentation, such as gas and high performance liquid chromatography (HPLC), spectroscopy (infrared and ultraviolet, amongst others); interpreting data and adhering to strict guidelines on documentation when recording data; reporting scientific results.

Complete testing of different Raw materials.

To test completely in-process (Bulk) samples of IV solutions, uncoated & coated tablets, capsules, & Eye Drops, etc.

Determination of %age composition of active components in the Drugs (SDF, Eye Drops IV & Syrups):

Volumetrically (Aqueous and Non-Aqueous Titrations)

Spectrophotometrically (UV/Visible)

Instruments calibration and maintain records.

Dispensing of raw Materials.

Experienced in preparation and standardization all the laboratory reagents for analytical work and keep records.

Assisted with Calibration of the laboratory equipment.

Involved to file the analytical records properly.

To inform the Quality Control Manager about the non-conforming results of analysis.

Education

Education

Subject

Division

Institutions

MSc.

(2005-2007)

Pharmaceutical Chemistry

Analytical Chemistry

Organic Chemistry

Physical Chemistry

Inorganic Chemistry

Industrial Chemistry

Mathematics

Advance Inorganic Chemistry

Advance Analytical Chemistry

Industrial processes and Quality Control

Biotechnology in Chemical and Food Industries

1st

GC University Lahore

BSc.

(2003-2005)

Chemistry (Organic, Inorganic and Physical), Botany, Zoology, English

1st

FC College Lahore

FSc.

Pre-Medical (Chemistry, Physics, Biology and English)

1st

BISE Lahore

Matric

Science (English, Chemistry, Mathematics, Physics, Biology, Geography)

1st

BISE Lahore

DCS

Computer

1st

Minhaj University

RESEARCH WORK

Development of Analytical Methods for Vitamins A & D and B1, B2, B3 and B6 in multivitamin tablets and syrups by using HPLC.

Development of Analytical Methods for Inositol, L-Carnitine, Mybulen Tab/Caps/Susp.

Validation of Methods (Loperamide HCl, Nitrazepam, Allopurinol, Hydralazine HCl, Meprobamate, Loprazolam etc.)

Physicochemical Analysis of Essential Oils of Nigella sativa by GC/MS Spectrometry.

Determine Minimum Inhibitory Concentrations (MIC) of Essential & Fixed Oils of Nigella sativa.,

Antimicrobial Activities of Essential Oils of Nigella sativa.

SPECIAL TRAINING

Received training form Microsep for operating of Water HPLC’s and UPLC’s and Empower 2 and 3 software’s at Pharmaspec.

Received Training on ISO 9001 (QMS), 14001 (EMS) & 17025 (LMS).

Special Trainings on GMP, cGMP, GLP, (Medipak Pharmaceuticals).

Comprehensive understanding of chromatograms and data management systems.

Document management and archival system and Track wise (document tracking system).

Working experience in research and development projects related to improve the

water quality of Pharmaceuticals etc.

COMPUTER LITRACY

High proficiency in Microsoft Excel, Access, Word and PowerPoint.

Operating systems used are Windows 7, 8, Vista, 98/2000/2003 server, professional, XP, NT, & ME.

Installation of Hardware & Software & Troubleshooting.

Networking, Internet & Email.

Scanning, Urdu/English Typing and In-page.

Data management.

Configuring TCP/IP

Establishment of Windows 2000/2003, XP (Home/Professional) Domain/LAN.

Strong knowledge of M.S. Office (Word, Excel, Power Point). Microsoft Visio (Maps, Sketches and Drawings etc.)

Networking

Hardware and Software installation and Trouble Shootings.

Internet.

INSTRUMENTAL EXPERIENCE

HPLC’S system (Waters), (Shimadzu) (Agilent), UHPLC’s Aquity (I-class & H-class) Waters, FT-IR spectrophotometer, AA, VU/Visible Spectrophotometer, Gas Chromatograph, Polarimeter, Karl Fisher Titrator, Flamephotometer, Coulter counter, D.T Instrument, Refractrometer/Brix Refractometer, Dissolution apparatus, pH meter, Conductivity meter, Friability tester etc.

REFERENCES

Provided on Demand.



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