Experience

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  Rangs pharmaceutical ltd.

  May 2008 - Jul 2009

  Production officer

   Prepare monthly production plan. Monitor and review production target. Receive the Input materials as per Manufacturing Instruction. Ensure resource utilization. Supervise Tablet, Capsule (Including Hard Gelatin Capsule with Liquid Filling) Manufacturing. Ensure proper training and evaluation of Sectional personnel. Prepare and Implement ISO-9001:2008 documentation in respect of cGMP. Leading a team of 18 persons smoothly and distribute their work accordingly. Facilitate machine trial on new products of PD timely. Show less

• 

  Eskayef pharmaceuticals limited

  Jun 2009 - Sept 2009

  Production pharmacist

   Supervise production activities at every stage complying cGMP in Tablet, Capsule, Dry Syrup (PFS) of Cephalosporin area Manufacturing & Packaging. Also Supervise Toll-in Products. Prepare monthly, weekly and daily production plan. Prepare & always up-to-date documentation work. Ensure proper utilization of Man & Machine-Hour. Undertake In-process check and ensure product quality as per specification. Supervise Machine Changeover as per SOP. Train up the employees to comply cGMP & UK MHRA norms at production area. Monitoring housekeeping & cleanliness. Lead a team of 70 persons smoothly and distribute their work accordingly. Show less

• 

  Sanofi

  Sept 2009 - now

  Quality Systems & Technical Review (50%):• Support Implementation leaders to initiate Corrective and preventative actions (CAPAs),monitor ER, CCR request in the Quality System.•Review CAPAs associated with recurring issues and escalate any issues to ETS PlatformLeaders via Deviation/CAPA review board.•Work with Platform Leaders to identify and develop process improvements to remediate risks.•Coordinate the CAPA implementation timeline in coordination with ETS planning &scheduling team.•Ensure that investigation reports and/or manufacturing investigation reports and root causeanalysis (RCA) are clear, concise, and comprehensive.•Support deviation investigation team to determine the scope of the investigation bycollaborating with QO, Manufacturing and Subject Matter Experts(SME) as appropriate in real time on the shop floor.Compliance Initiatives & Continuous improvement (40%):• Support staff & technical writer on identifying, updating & harmonizing ETS procedures.• Lead and coordinate internal and external regulatory audits representing ETS.Develop and maintain ETS Subject matter expert list and have regular touch points toexplore process improvement opportunities.•Develop and lead initiative to identify exception to ETS processes on a monthly basis. Find opportunities to optimize existing process with emphasis to compliance, quality and HSE.•Work with Platform Leaders to identify and develop process improvements to remediaterisks.•Lead continuous improvement initiatives as outputs of investigations and provide compliance direction.• Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable.Cross-functional Collaboration (10%):• Lead cross-functional team meetings to review deviations/CAPA/CCR and topics relevant to ETS compliance.• Participate in special projects for ETS process improvement projects to meet and address inspection observations.• Provides metrics and other reports as required. Show less • Supports Engineering Technical Services group across the site. • Ensure failure investigations/deviations are processed and that problem resolution occurs prior to commitment date within SAP. • Ensuring timely review, follow-up on, closure and approval of various documents, such as: master and executed batch records, operational log books, sterilization and dehydrogenation records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, maintenance task lists, that are within the scope or delegated.• Perform the role of QO Representative in coordinating, investigating and assessing Change Control Requests (CCR’s) and CAPA for IO, as designated within this process.• Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close contact with the various departments.• Oversee in conjunction with the QO Quality System Internal Auditor and Vendor Auditor, perform audits and support functions performing GMP activities to ensure compliance with cGMP standards, site and corporate policies.• Regular member of QO Representative at various internal and external committees and board related to the management of the organization, such as: Sanofi Pasteur Change Control Board, Material Review Board.• Make assessment decision and authorization for processing / reworking, manufacturing at risk.• Perform data gathering and analysis of non-conformances to support annual product review.• Ensure Project team participation. Show less Played an active role in Quality Culture Change and working on QMS improvement at Sanofi Limited.• Quality Management/Continuous Improvement: Design & roll out of the QMS of the Company throughout all the GxP regulated activities, and across the entire lifecycle of Sanofi products and services.• Ensure QMS at Site Level: - QA Batch Product Releases: Auditing of batch documents and completing final release on SAP for market. - Ensure manufacturing site adherence to GMP requirements.- Implementing the Complaint Investigation system: CC System, System for handling of Deviation and Failure Investigations & identification of action plan for CAPA measures.- Site DI Focal Point: Created and Implemented a New DI Master Plan. - Successfully managed number of local and global audits (PIC/S,GQA, J&J, UNICEF)- Ensures Risk Assessment (Pro-active & Re-active) are properly managed. - PQR- Management and preparation of Product Quality Reviews. - SMF- Preparation, review and approval.- Conduct Third party supplier audits and Self-Inspections Audits. - Quality KPI’s Follow-up, Report, analysis and implement action plan. • IPQA: Supervise In-process Quality Control. • Regulatory and cGMP Compliance: Preparation, Compilation and Review of Registration Dossier for Export and local market.• Sub-contractor (CMO) and Supplier Quality Assurance: Vendor, CMO and Contract Laboratory Development, Auditing, Approval and Monitoring. • Qualification & Validation: Participate in development, approval & implementation of SVMP. • Documents Control and Management: Preparation/ Review / Approval of quality system SOPs and all cGMP documents & Controlled these Master documents by distribution and archival. • Training Management: Develop training modules, Manual & Package for OJT and conduct basic cGMP training for site. • Project Work as a Project Leader: |WAVE Project (Cultural Transformation for cGMP Compliance) | HEP (Human Error Prevention) Project. Show less • Responsible for monitoring of Granulation, Compression, Coating, Encapsulation, Suppository filling & Sealing, Cream filling, Liquid filling, PFS filling, Aseptic Vial Filling and packaging area. • Schedule and monitor of monthly production plan as well as weekly plan based on priority, material availability and manpower distribution.• Daily room inspection, process check, log book entry and monitoring, deviation and change control handling and overall implementation of cGMP in the area of responsibility.• Preparing and updating of necessary documents - BMR, PR, SOP etc.• Allocation of responsibilities among the department employees ensuring balanced and realistic distribution of workload.• Finding the different ways of cost reduction and implement them effectively.• Preparation of URS of different production equipment’s and Evaluation of Technical Comparatives.• Raising different types of Events/proposal related to products such as Deviation Report, Change Control, Reprocess Request, Batch Tailing Request, Product Disposal as required.• Identify training needs, Prepare Yearly training Plan and conduct training program to improve efficiency as per requirement (Like SOP, cGMP, Housekeeping and cleaning).• Analyze time and manpower requirement to increase productivity by minimizing the loss percentage.• Developed associates to skilled level regarding cGMP, sophisticated machine operation & behavioral actions.• Monthly KPI's Reporting and analysis i.e. OEE, Wastage/Yield, PCT and Labour hour Variance.• Conduct interdepartmental liaison in order to keep smooth run of production.• Team work for the implementation of Global Guideline, investigation, audit etc.• Supervision of a large workforce of different grade and yearly appraisal.• Active Role in Project Work: |Simplification Project | Mix-up prevention Tools implementation | Liquid Product Transfer Project | IGNITE Project for COGM Improvement | Show less

  • Manager, ETS Process Compliance – Vaccines

    Oct 2024 - now

  • Manager, Operation Quality TS

    Jun 2022 - Sept 2024

  • Senior Quality Assurance Manager

    Nov 2017 - Jul 2022

  • Quality Assurance Manager

    Mar 2016 - Nov 2017

  • Assistant Manager, Quality Assurance

    Nov 2015 - Mar 2016

  • Assistant Manager Manufacturing

    Mar 2015 - Nov 2015

  • Senior Executive, Manufacturing

    Mar 2014 - Mar 2015

  • Executive, Manufacturing

    Mar 2012 - Mar 2014

  • Sr. Officer, Manufacturing

    Apr 2011 - Feb 2012

  • Officer, Manufacturing

    Sept 2009 - Mar 2011
• 

  Thermo fisher scientific

  Dec 2021 - Jun 2022

  Qa associate (recruiter- resolute workforce solutions)

  • Review executed processing and packaging batch records and associated E-Data (SOTAX, Q-DOC, TrackWise) procedures and client requirements to meet departmental/client schedule.• Communicate with clients on any questions or concerns regarding procedures and/or documentation for both change controls and batch records.• Ensure that all documentation related to bulk and finished product release is collected and compiled prior to release.• Conduct Proficiency & DI training to Shopfloor Technologist, Team Leader and Supervisor regarding. • Execute release of bulk and finished products by updating SAP system, prepares release documentation and forwards to the necessary internal departments.• Ensure that clients are forwarded scanned copies of necessary documentation prior to release of bulk and finished products or for approval of change controls.• Perform associated Quality on the floor tasks, including but not limited to, participation in RAPIDS (e.g Deviation or OOS) and review of production logbooks• Ensure change control activities as a change control Associate (Support during afternoon shifts as needed)• Work on special projects related to the Quality Department’s Continuous Improvement Plan. Show less