Muhammad Shoaib Akhtar

Experience

• 

  GSK

  Feb 2002 - Sept 2005

  Job Responsibilities:•Development and Training of Stability Team and Laboratory Operation officers.To prepare stability, commercial/ongoing stability, post market surveillance stability protocols•Performed Stability analysis of as per ICH and GSK global guidelines•Responsible for compilation of stability results, reports and trend charting•Responsible for the maintenance, review and regulatory submission of stability data/results•Performed analysis of complaint samples•Active member of OE (Operation Excellence) project team•OOS/OOT investigation•Performed SITE Annual Product Review•5-S implementation• Actively participate in Process/ cleaning validation activities•Conducted Good manufacturing practices lectures to all workers and staff members.Key Achievements:•Saving PKR 2 Millions by utilizing of citric acid by developing suitable and validated composition in ENO•Played a vital role in technology transfer of Sensodyne tooth paste from Maidenhead, UK to Karachi, Pakistan•Successfully performed stability studies for the implementation and execution of conversion of bottle pack into new launches Alu Alu Blister Augmentin tablet 625 mg & 1 gm•Recognition from GSK head quarter UK in best SITE Annual Product Review reporting•Active contribution in conducting of Measurement System Analysis (MSA) of Augmentin Tablets Value Stream•Yield improvement at Penicillin products by controlling weight variation & wastage at manufacturing & Packaging stage on all products•Performed Measurement Systems Analysis (MSA) on Augmentin 375 mg and 625 mg tablets. Show less Job Responsibilities:•erformed in process .Performed QA monitoring of raw material for their Physical inspection, Sampling. Release and dispensing of materials and also conduct, in process check for QA.•Prepared monograph, various Formats, tables, plans required in GLP•Conducted Good manufacturing practices lectures to all workers and staff members•Participate in Process Validation activities of manufacturing procedures•Batch Release, Change Control Implementation, In-process monitoring from dispensing to packaging, Facility GMP compliance, Handling of deviation and CAPA, Quality Investigations, Risk Management, QMS Implementation, review of manufacturing and packaging instructions and other production documents.Key Achievements:•Yield improvement at Penicillin products by controlling weight variation & wastage at manufacturing & Packaging stage on all products•Provided full support to Engineering in installation & validation of Krones labeling, capper & cartoner machines on tablets line for better efficiency & output. Show less Job Responsibilities:•Performed sampling as per sampling plan and completing the relevant documents of incoming materials• Performed analysis of raw materials and bulk / finished goods like Augmentin, Amoxil, Ampiclox, Orbenin, Penbritin, Macleans Tooth Paste and Eno•To provide support junior staff for trouble shooting on analytical equipment•Member of Environmental Health Safety team from Quality Department•Testing of procurement samples•Worked on instruments like HPLC, Gas Chromatography, F.T.I.R, UV Visible Spectrophotometer, Karl Fischer, Dissolution apparatus, Refractometer, Polari meter, FTNIR etc•To compile analytical reports using QUARTS (Quality Assurance Reporting Systems).Key Achievements:•Developed & transferred Macleans tooth paste testing from Extrusion method to Viscosity.•Refilling/ Regeneration of HPLC columns.•Excellent command on HPLC, Gas Chromatography, F.T.I.R, UV-Visible Spectrophotometer, Auto Analyzer, Karl Fischer, Dissolution apparatus, Refractometer, Polari meter, FTNIR etc. Show less

  • SITE In-charge Product Development & Monitoring Labs.

    Jan 2004 - Sept 2005

  • Quality Assurance officer

    Feb 2003 - Jan 2004

  • Quality Control officer

    Feb 2002 - Feb 2003
• 

  Reckitt

  Sept 2005 - now

  Led the Quality Control functions (Healthcare & Hygiene Home) of the company• Manage all Quality Control and DRAP related Quality matters.Key Achievements:• Successful GMP inspection by Drug Regulatory Authority of Pakistan (DRAP)• Successfully achieving Mortein LED manufacturing license renewal from NAFDAC (National Agency for Food and Drug Administration and Control, Nigeria)• Successful RISK Based GMP inspection by Drug Regulatory Authority of Pakistan (DRAP)• Successful Full Assessment Audit of ISO 17025-2017 Accreditation from PNAC• Successfully implement RPS (Reckitt Production System)• Successfully achieving drug license renewal from DRAP.• Successfully represent Quality and support others supply functions in Global Quality Audit• Successfully represent Quality Control in Internal Quality audits, Global EHS Audits, Halal certification and SLT Gemba• Successfully achieved ISO 9001-2015, Cosmetic GMP 22716 & Halal PS 3733 certifications• Quality Control and DRAP related Quality matters. Show less I worked as QA Manager with complete responsibilities and authorities having the title of Assistant Manager QA. Direct reported to Site Quality Head.• Managing various aspects of Quality Management System to maintain compliance with current corporate, regulatory and industry best practice guidelines• Handled / led Quality & GMP audits / inspections by local regulatory authorities and by corporate global team.• Implementation and management of Quality KPI• Ensured that all equipment (Production and Quality) are in calibrated status and take appropriate corrective actions in case of any deviation• Performed Annual Product Quality Review (APQR) as per Global Pharma SOP and identify area of improvement.• Global audits and compliance.• Review and implementation of batch manufacturing and batch packaging record.• Responsible to ensure that all production activities are carried out according to GMP guidelines• Preparation of batch records, standard operating procedures, specification and procedures, protocols, reports and other miscellaneous documents.• Managed proper upkeep and maintenance of Batch history records / documents and finished product retention samples. • Responsible for managing in-process control Show less • Manage Lab operation to satisfy the commercial needs in testing Raw Material, intermediates and finished goods•Ensure adequate training, coaching and development of potentials• Organised staff meetings to follow-up on team’s deliverable • Manage personnel including interviewing, hiring, performance reviews•Ensure follow-up of corrective actions and preventive actions •Performed Internal audits. •Ensure a safe working environment to meet site safety objectives (HSE),To prepare Daily Quality Report •Collaboration with Production, Planning, Project, Stores and Procurement for day to day activities•To supervise Stability studies of OTC, Pharma products•Validation of analytical testing methods•CAPEX budget management •Cost Control/ Effectiveness•Ensuring GLP, EHS compliance and GDP in QC.•New Products Development and Existing Product Development• KPI reporting•OOS/OOT investigation of results and reporting to senior management• Risk Assessment•Developed Product’s COA for export•Lead the team in preparation for the audit during, external agency and internal RB audits• Use of statistical tools both in terms or application and interpretation•Handling of Complaints/ DRA samples• Manage Calibration of Instruments•Development of product specification based upon different pharmaceutical compendia•Maintained cGMP and good housekeeping• To coordinate with suppliers regarding IQ, OQ & PQ of newly purchased analytical equipment.Staff: 07Reporting to: Quality Control Manager and Quality Manager Key Achievements:•Quality Agreements and Quality Safety Materials Manufacturer Questionnaire documentation with RM/PM Suppliers•Implement CAPA at Packaging Supplier•Trained and developed team for Phrama products and stability activities•Purchasing new Equipments for Quality Lab (e.g., HPLC, GC, Dissolution, Polarimeter etc..) and arrange IQ, OQ, PQ•Implemented Periodic Product Review•Initiate and implemented team performance review program•Performed GAP analysis Packaging materials. Show less • Performed testing of finished products, Raw Materials, Packaging materials, intermediate products, stability samples and project related samples including contract manufacturing products (Pharma and house Hold).• Preparation of QC/ QA and Production Master Method documents.• To perform Quality Audit of suppliers & Co-packers.• To ensure ISO 9001:2008 & ISO 17025 compliance for mauripur & ensuring successful surveillance audits..• Actively supervise Export of Mortien Mats, LED, VEET, to Malaysia, Saudi Arabia, Philippines, Spain, Kenya via performing and supervising testing as per export courtiers standards• Ensure proper New Product Development/Existing Product Development trial activities with Supply excellence team and report success/failure to Supply team with highlighting areas of improvement for way forward.• Competency on FMCG products, VEET, MORTIEN, ROBIN LIQUID BLUE, CHERRY BLOSSOM, STREPSILS etc.• Developed COA for export of House Hold /Pharma products.• Provided timely assistance to the Q.C.M in testing for Technical Center and project related stability Studies.Staff: 03Reporting to: Quality Control Manager Quality Manager Key Achievements:• Active member from Quality of Export Team.• Revised and implemented Stability Program.• Trained and developed team for House Hold products activities.• Transfer CB liquid White Technology to Prime from RB through Technology Transfer Exercise.• Developed testing method on GC for Mortien range products and trained the team.• Performed validation studies for Exports batches (Brazil, Malaysia, Spain, Kenya, South Africa and Middle East).• Completed Harpic Liquid Bench marking project.• Generation and updating of specification. Show less • Performed testing of finished products, Raw Materials, Packaging materials, intermediate products, stability samples and project related samples including contract manufacturing products (Pharma and house Hold).• Ensure proper New Product Development/Existing Product Development trial activities with Supply excellence team and report success/failure to Supply team with highlighting areas of improvement for way forward.• Competency on FMCG products, VEET, MORTIEN, ROBIN LIQUID BLUE, CHERRY BLOSSOM, STREPSILS etc.• Developed COA for export of House Hold /Pharma products.• Provided timely assistance to the Q.C.M in testing for Technical Center and project related stability Studies.Key Achievements:• Developed SOP for instruments.• Developed testing method on GC for Mortien range products and trained the team.• Completed Dettol Soap Bench marking project.• Developed Standard Calibration Procedures.• Generation and updating of specification. Show less

  • Site Quality Liaison Manager

    Dec 2024 - now

  • Senior Manager Qaulity Control (Healthcare & Hygiene Home)

    Jul 2019 - Feb 2025

  • Assistant Manager QA (Acting QA Manager)

    Jun 2016 - Jul 2019

  • Acting QC Manager

    Jun 2015 - Jun 2016

  • Assistant Manager QC (MMG-2)

    Jan 2013 - Jun 2015

  • Middle Manager QC (MMG-1)

    Aug 2008 - Dec 2012

  • Senior Quality Control Executive

    Feb 2007 - Jul 2008

  • Quality Control Executive

    Sept 2005 - Jan 2007