Experience

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  SAMI Pharmaceuticals (Pvt.) Ltd.

  • Karāchi, Sindh, Pakistan

  • Deputy Manager QC-R&D & QC Compliance

    • Oct 2022 - Present
    • Karāchi, Sindh, Pakistan

    Major Activities Performed as Team LeaderProduct Development, Stability Activities and Method Development, Validation and Verification • Managing all kind of product development activities related to new products launch and other formulation changes time to time from PDU. • Method developed and validation performed in house for new products if they are not present in any pharmacopeia. • Time to time review of pharmacopeias if any new update available in pharmacopeia.Major Activities Performed as Team LeaderProduct Development, Stability Activities and Method Development, Validation and Verification • Managing all kind of product development activities related to new products launch and other formulation changes time to time from PDU. • Method developed and validation performed in house for new products if they are not present in any pharmacopeia. • Time to time review of pharmacopeias if any new update available in pharmacopeia. Major Activities Performed as Team LeaderProduct Development, Stability Activities and Method Development, Validation and Verification • Managing all kind of product development activities related to new products launch and other formulation changes time to time from PDU. • Method developed and validation performed in house for new products if they are not present in any pharmacopeia. • Time to time review of pharmacopeias if any new update available in pharmacopeia. QC Compliance/QMS• Perform internal External audits • Reviewing of SOPs• Review of Specifications and Methods.• Reviewing of CAPAs• Reviewing of IQ/OQ and PQ documentation.• HSE related ActivitiesCertifications • ISO/IEC 17025 assessor certified trainer • L1 and L2 Auditor (core 100) • Communication skills• Crisis management- Qualified Trainer- Technical Risk Assessment- Management of Deviations and OOS- Data Integrity- Management of CAPA- Validations- Train the Trainer - OJT trainer

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  Haleon

  • Jamshoro District, Pakistan

  • Assistant Manager OQ/IPC Specialist |xAM Stability Lab

    • Jul 2022 - Oct 2022
    • Jamshoro District, Pakistan

    Major Activities Performed• Release of products in SAP.• Change Control management• Deviation and Event Management• CAPA and RCA Management• SOPs Preparation, Gap assessment against (GQP and GQMPs) their review and implementation across the site as per their options 1 and 2.• File Auditing • (local ministry and regional GEMBAs)• Daily, weekly & Monthly KPIs updating to Site Quality• Veeva and QMS related activities• Work as per local and global regulatory requirements and assure all the production processes, equipment's and Procedures are being followed as per cGMP guideline / Local cGMP regulation.• Providing data for PPR/APQR to track the trends of CPP and CQA.• Support in CTD- (Common Technical Documents) i.e., Panadol Extend and Panadol Syrups Launch and some products are in pipeline.• Apply GPS tools in problem solving.• Part of IRT team (inspection readiness team).• L1(self-inspection) and L2 Audits

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  GSK Consumer Health

  • Jamshoro, Pakistan

  • Assistant Manager OQ/IPC Specialist

    • May 2022 - Jul 2022
    • Jamshoro, Pakistan

    Major Activities Performed• Release of products in SAP.• Change Control management• Deviation and Event Management• CAPA and RCA Management• SOPs Preparation, Gap assessment against (GQP and GQMPs) their review and implementation across the site as per their options 1 and 2.• File Auditing • (local ministry and regional GEMBAs)• Daily, weekly & Monthly KPIs updating to Site Quality• Veeva and QMS related activities• Work as per local and global regulatory requirements and assure all the production processes, equipment's and Procedures are being followed as per cGMP guideline / Local cGMP regulation.• Providing data for PPR/APQR to track the trends of CPP and CQA.• Support in CTD- (Common Technical Documents) i.e., Panadol Extend and Panadol Syrups Launch and some products are in pipeline.• Apply GPS tools in problem solving.• Part of IRT team (inspection readiness team).• L1(self-inspection) and L2 Audits

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  GSK Consumer Healthcare Pakistan

  • Jamshoro

  • Assistant Manager Stability

    • Jan 2020 - May 2022
    • Jamshoro

    Assistant Manager QC, proficient in all phases of the Quality Assurancei.e. QC, QA, QS and Compliance Department. Adept at working withGSK methodologies to accomplish project milestones according tospecific time frames and requirements.Skills & Responsibilities▪ Managing all kind of stability Lab related tasks with timely such as i.e.Stability Protocol preparation for Post Approval variation stability study, New ProductIntroduction (NPI), Process Deviation stability protocols, ongoing protocols for annualmonitoring of stability study. Types of Protocols i.e. Accelerated, Long Term,Collective Stability Study and Ongoing.▪ Stability Report preparation for submission of Tenders, Regulatory requirements andto fulfill requirements of third-party contractors.▪ Analytical Method Validation/Verification from starting of making AMV protocols thantesting of required parameters to complete with AMV report writing completion.Annual review of analytical methods than scheduling them and revising after threeyears.▪ Thermostability Study (TST)- Protocol, execution of testing plan and reportpreparation.▪ Project management- New Product Introduction (NPI) responsible of all new productswhich are in innovation pipeline and have been completed at site i.e. Stability profilegeneration by establishing their shelf life. Tech-Transfer- part of tech transfer team as SME from Quality Control to prepareProtocol of Method transfer, Knowledge transfer and complete all other activities.▪ Preparation of Cleaning Method Validation plan and protocols than scheduling itstesting after that complete its report.▪ Good at CDMS (Controlled Document Management System) CDMS used for allcontrolled documents i.e. SOPs, Protocols, Reports, Analytical Methods and formsetc. all document prepared, reviewed and Approved by CDMS.▪ Expert at “One CDS Empower”. Its Chromatography software system which isapproved by FDA and compliant on CFR 21.Handling and investigating OOS (L1 and L2)

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  GSK CH

  • jamshoro pakistan

  • Quality Control Executive

    • Jun 2016 - Dec 2019
    • jamshoro pakistan

    Skills • Quality management System (QMS)• Level 1 & level 2 Audit• Became part of CAG (Compliance Audit Group)• Protocol Author• SOP Author• Empower expert• Ability to work as section in-charge• HPLC Shimadzo, Agilent and Waters HPLC trained• EHS Knowledge• PC Knowledge• Excellent oral and written communication skills• Experience in the maintenance and calibration of analytical equipment• Strong Technical and Product knowledge together with Quality oriented approach• Develop and maintain inventory of laboratory chemicals and equipment accessories• Provide training to junior staff on new test methods and QA procedures• A good team player and have strong interpersonal skills• Works well in a fast-paced team environment and individually• Ability to manage multiple projects and tasks concurrently and effectively• Working closely with others in the group to achieve business objectives• Excellent scientific writing skills with the ability to troubleshoot analytical issues and other deviation reports suitable for review by regulatory agencies• Handling and investigating OOS Deviations• Support team AS&T in solving quality related problems• Strong customer service experience and a background of achievement in supporting all Levels of management & working to set schedules and deadlines• Risk management processes and analysis• Public speaking• Data management• Self-motivated• Conflict resolution• Team leadership

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  Novartis Pharmaceuticals company pakistan

  • Hydrabad jamshoro

  • Quality Control Executive

    • Dec 2015 - May 2016
    • Hydrabad jamshoro

    Executive quality control officer at Novartis Pharma (OTC) Pakistan since December 2015. As the member of Analytical Science and Technology (AS&T)Responsibilities Testing and documentation of products which are under stability studies on time.Control their shelf life period and give them expiry date.Prepare monthly schedule of stability testing.Validation of all new analytical methods and verifying of analytical methods which are USP & BP related. Maintain analytical reference standard in categories as primary, secondary, and working standards.Support team AS&T in solving quality related problems.

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  GSK

  • GSK WEST WHARF

  • Quality Control Officer

    • Jan 2013 - Nov 2015
    • GSK WEST WHARF

    · SPANSULES SECTION.· INJECTABLES SECTION.· OTIC AND DROPS SECTION.· CONSUMER HELTH CARE SECTION.· RAW MATERIALS SECTION.· OINTMENTS, LOTIONS AND CREAMS SECTION.· Good theoretical and practical knowledge of instrumental techniques such as HPLC, GC, UV-VIS Spectrophotometer, KF, PH METER and CONDUCTIVITY meter etc.· Experience in the maintenance and calibration of analytical equipment. · Perfom Maintenance and Calibration of Analytical Equipment as required. · Perform accurate and timely analyses on raw materials and finished products of different dose forms (solid dose, liquids, topicals). · Perform analyses using HPLC, GC, and UV, wet chemistry and numerous other analytical methodologies and techniques.· Perform Method Validation of analytical test methods. · Document all laboratory testing and maintain accurate and legible logbooks and records. · Record analytical results in LIMS.· Perform all work according to cGMP following regulatory and GSK standards. · Assist the Team Leader and Manager in determining the root cause of laboratory deviations providing clear and concise documentation of the event. · Good knowledge of laboratory cGMP and demonstrated proficiency in analytical techniques. · To impart on job safety take part in trainings.· To participate in the preparation of weekly manufacturing schedule with the Manager and follow the daily manufacturing program according to production schedule.· To ensure that cGMP standards are maintained and Company’s procedures are followed during the Manufacturing.· Checking of BMRs on daily basis and maintain GLP.Achievements:• HPLC, POLARIMETER,VISCO METER etc trained and use all other instruments which are being used in lab and develop new comers .• GAS CHROMATOGRAPHY. • Global Record retention Representative.• Deviation Representative.• Periodic Product review Representative. QMS Representative. Health Safety and Environment (HSE):

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  private collage

  • city

  • Teacher

    • Aug 2009 - Dec 2012
    • city