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<pre>Array ( [var] => cut_url ) </pre> Resume for Ashfaq A. for Manager / Supervisor / Team Leader / Biotechnology & Pharmaceuticals in Butterworth, Malaysia. Search More Resumes for Manager / Supervisor / Team Leader on Resumark.com #ZGAWKY8UH
 

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Resume for Ashfaq A. for Manager / Supervisor / Team Leader / Biotechnology & Pharmaceuticals in Butterworth, Malaysia




Occupation: Manager / Supervisor / Team Leader Industry: Biotechnology & Pharmaceuticals
Country: Malaysia City: Butterworth
State: Pulau Pinang ZIP: 12000



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ashfaq A.

,E st street shivaji road Bangalore, India  

MANUFACTURING/PRODUCTION Focused Manufacturing Manager

Offering extensive Manufacturing/ Plant commission/Process Scale up/ Process optimization/ process Validation/QA experience and proven technical and leader skills

Career Summary

Analytical, result driven Manager with over years experience with a diverse blend of process development, technology transfer and commercialization knowledge for API and drug substance manufacturing experience. Proven leadership skills/Project management /manufacturing/ regulatory compliance/QA experience regulated cGMP. Led an implementation of technology transfer process of pilot scale to manufacturing scale with quality systems and programs, ensuring compliance with quality standards and regulations. Identified compliance risks, scale up issues, process and equipment trouble shooting; guided manufacturing efforts at all levels. Solid analytical, investigative, technical and problem solving skills. Resolved product, process, regulatory and audit issues. Aggressively investigated process deviations, risk and nonconformances; initiated and evaluated preventive and corrective action programs for biopharma department. Implemented Quality Risk management procedures for the manufacturing plant, having considerable knowledge and experience of FDA, EMEA, Saudi FDA, GLP and cGMP. Formulated and maintained manufacturing and quality control objectives in collaboration with QA for production department.

Product characterization: Planned and executed the virus clearance studies using the intermediates and final API to get required log reduction ICH QA.

Cell bank characterization: as per ICH guideline ICH QC D, B. Wrote technical reports, Commissioning master plan, Manufacturing procedures, Master Packaging procedure, Validation master plan, Validation protocols for process and cleaning, drug registration documents CTD, SFDADMF. Stay abreast through workshops, conferences, certifications, and professional development.

Proficiencies:

v  QA/Process Improvementv Plant Commissioning/Process scale up/optimization/Process Validation 

v  CGMP/SOPs/Work instruction/Manufacturing procedure/Packaging procedures/VMP/DMF/CTD/

v  Audits Internal Production v Regulatory Compliance v  IQ/OQ/PQ Protocols

      Process Validation protocols and designing the study for validation studies.

v  Technical Writing v  Quality Systems             v  Change/Document Control

Achievements’ Highlights
  • Contributed and actively involve in the process of mammalian cell culture manufacturing and optimized, actively involved for making marketable batches with meeting all the requirement from regulatory body, where the country like Saudi is new to the techniques of biotechnology.
  • Demonstrated ability to motivate by the personal example
  • Achieved “Important Contribution award for scaling up the process of HUMAN INSULIN rDNA to plant scale. From L to KL Capacity Scale up
  • Suggested for a process development a key change resulted in doubling an API yield. recombinant erythropoietin
  • Brought a change in production pipeline modification and flow process for usage of equipment for production which has help a lot to achieve smooth flow of process.
  • Wrote the risk analysis report for biotech business for claiming the insurance for the business.
  • Supervised, developed, and trained team of + professionals.
  • Suggested for Manufacturing projects, quality and regulatory procedure implementations; conducted internal audits to ensure compliance with cGMP, SOPs, and other regulatory compliances.
  • Planned, promoted, and organized training, including deviation reporting and corrective action training for manufacturing team.
  • Aggressively drove improvement in manufacturing processes and systems and team and staff development.
  • Initiated process improvement, improved quality, optimized processing time, and lowered errors/costs.
  • Aggressively reduced process and documentation errors/omissions by introducing Risk management process
  • Streamlined document control to achieve efficient control and distribution of documents and procedures.
  • Improved manufacturing process and quality process through process improvement and training.
  • Professional Development
  • Trained on Risk based approach techniques and risk based approach validation – trained by CFPIE.
  • Trained on GMP, GDP , GXP CFR rules
  • I was a member of Institute for Human Potential and development.
  • Have attended the workshop “ THE WINNER” IN DELHIINDIA  conducted by Institute for Human Potential and development
  • Attended seminars related to lypholisation and chromatography.
  • Trained on all the aspects of personnel management interviewing, training, coaching and developing
  •             Aware of basic lean six sigma techniques still I am a beginner but currently practicing the same.

    Professional Profile cGMP Manufacturing Manager Recombinant protien and MAB products

    OCT Present

    ALPHA BIOLOGICS SDN BHD – MALAYSIA A unit of VIROPROA US Public company

    Oversee Four areas:

    Manufacturing Section: Managing all the activities of the department Upstream and downstream section including cost saving, process improvement, new techniques implementation.

    Direct production functions and safety procedures in accordance with EHS/OSHA regulations. 

    Developed manufacturing plant with a handson approach to assigning staff responsibilities.

    Created a unified company infrastructure that aligned with business mission strategy. 

    Ensure the maintenance of production equipment using inhouse and external technicians.

    Coordinate staff hiring, training, supervision, and performance evaluations.

    Effectively implemented quality systems to ensure compliance of manufactured drug substance within cGMP.

    Responsible for the hands on, daily direction of GMP manufacturing operations and personnel within the manufacturing suites.

    Quality Service:

  • Responded to internal audit reports; initiated corrective actions for audit findings.
  • Facilitated Manufacturing process with quality system by writing/revising SOPs and leading process improvement projects in team environment.
  • Interface with suppliers, external labs , consultants and regulatory Agents FDA and EMEA
  • Create comprehensive procedures and prepare and report for the external lab results.
  • Catalyzed technology transfer

  • Implementation of technology transfer technique to manufacturing scale
  • Leadership:

  • Direct department of + professionals; assisted group with manufacturing , quality and regulatory training.
  • Project  Manager Biopharmaceutical Facility commissioning and  Project Management

    JAN Present

    ALPHA BIOLOGICS SDN BHD – MALAYSIA A unit of VIROPROA US Public Company

  • Successfully managed over a milliondollar project through managers and other.
  • Provide technical and management expertise and leadership.
  • Client relation’s management and other professional and institutional relationship development and management.
  • Strategic leadership in the planning and execution of project.
  • Sr Specialist Biodownstream Mammalian Cell culture technology                                                                                                                                                                                      –Present Saudi pharmaceutical industrial and medical appliances corporation, Al Qassim, KSA. Pharmaceutical and Medical Device Company specializing in injectable and oral drugs and manufacturing + parenterals

    Manufacturing Section: Managing all the activities of the department downstream section including cost saving, process improvement, new techniques implementation,

    Effectively implemented quality systems to ensure compliance of manufactured drug substance within cGMP.

    Responsible for the hands on, daily supervision of GMP downstream manufacturing operations and personnel within the manufacturing suites.

    Quality Service:

  • Responded to internal audit reports; initiated corrective actions for audit findings.
  • Facilitated Manufacturing process with quality system by writing/revising SOPs, manufacturing procedures and leading the process improvement projects in team environment.
  • Drug Registration documents – all the regulatory compliance documents preparation workCTD Module and Module
  • Interface with suppliers, external labs , consultants and regulatory Agents
  • Create comprehensive procedures and prepare the reports for the external lab results.
  • Catalyzed technology transfer

  • Implementation of technology transfer technique to manufacturing scale
  • Scale up techniques , Scale up summary reports , technology transfer comparability protocol.
  •  

    ExecutiveProduction : Shift In ChargeRecombinant Protein technology Downstream process HUMAN INSULIN PLANT APRIL JAN

    BIOCON LTD: Indian largest biotech company 

  • Job includes interfacing with highly automated production system and controls, and maintaining areas in a high state of inspection preparedness
  • Ensuring the production targets are met within the given time,
  • Production planning, work assignment to team mates.
  • Responsible for the hands on, daily supervision of GMP downstream manufacturing operations and personnel within the manufacturing suites.
  • Responsible for all day to day operations in the GMP manufacturing suite, as assigned. Specific responsibilities will include:
  •  

    HUMAN IN Oral Insulin: BIOCON LTD: Indian largest biotech company

    ExecutiveProduction : Shift In Charge JAN MAY  

  • Scaling up oral insulin to production scale to L to L.
  • Actively involved for generating material for toxicological studies
  • Carried out the conjugation reaction and transpeptidation reaction
  •  

    R & D: BIOCON LTD: Indian largest biotech company

    Jr ExecutiveProduction JUNE APRIL  

  • Joined with member of doctorate team, for developing human insulin recombinant protein.
  • Involved in commissioning and stabilizing the pilot plant L fermentor for generating the material for toxicological studies and clinical studies.
  • Scaling up Downstream process of Recombinant Human Insulin from L to KL fermentation.
  •  

    ENZYMES & STATIN PRODUCTION: BIOCON LTD: Indian largest biotech Company

    Jr.ExecutiveProduction:  JUNE – MAY : 

  • Operating and basic troubleshooting of production equipment maintains complete and a accurate record of Equipment log book, batch manufacturing records, work effectively and efficiently in a team –oriented environment to keep manufacturing operations running produce a quality product and changes whenever necessary.
  • Panel operation and unit

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