S K Navidullah
Tel: 0253-2469385  Mobile: 09552536419
E-Mail: sknavidullah@rediffmail.com
Production Management Specialist
With enriched experience of 25 years in managing entire Production & Quality Operations
Since Sept 1991, working with GlaxoSmithKline Pharmaceuticals Ltd. a leading Multinational organisation.
Qualified with extensive experience in dosage forms like sterile (21 years ) , and tablets (4 years) , worked in the
field of Manufacturing Operations, Quality and Process Enhancements in the Pharmaceutical industry; taking cost-
saving initiatives to optimize efficiency and enhance productivity. Presently associated with GlaxoSmithKline
Pharmaceutical Ltd., Nasik as Manufacturing Manager.
Holds technical competency in dosage forms of secondary pharmaceuticals manufacturing. Good in effectuating
various quality standards and productivity improvement tools 5S, Lean sigma, involving resource planning,
in-process inspection, team building and co-ordination with internal / external departments.
Good knowledge for preparation of FDA, Group (UK), and Level-1 to Level -4 audit, an enterprising leader with the
ability to motivate personnel towards achieving quality objectives and adhering to industry best practices.
Effective communicator & negotiator with strong analytical, problem solving & organizational abilities.
AREAS OF EXPERTISE
Production Operations
 Planning day-to-day strategies, budgets, manufacturing schedules, along with resource allocation and machine
loading for optimum output of manufacturing division of sterile (dry powder Cephalosporin and liquid injectables)
department and tablets .
 Minimizing performance bottlenecks for high productivity by maximizing men, material & machine.
 Appraising the prevalent manufacturing systems/ processes, identifying loopholes if any and undertaking result-
oriented measures for alleviating them and documenting the same.
Quality
 Implementing Quality Management System (QMS), taking stringent quality measures by implementing, 5S, Living
safety, Lean Sigma, at the site. Preparation of necessary documents to ensure compliance with Regulators like
FDA.
 Supervising CAPA teams to find out root cause & implementation of preventive measures.
 Imparting on the job trainings to operators & supervisors on quality systems.
 Carrying out gap analysis to bring SOP’s and BMR in line with Global Quality Policies and Global quality
Management systems.
 To identify training needs of management and non management staff and initiate and / or impart adequate
training needs in functional, GMP and Safety aspects.
 Handling of Change controls, Process Deviation Reports, CAPA and Out of Specification.
Process Enhancements
 Educating the personnel regarding Root Cause Analysis & CAPA Management.
 Identifying scope for:
 Planning / implementing technological changes to enhance efficiency.
 Modifications in equipment, process flow, working practices, consumables, etc. for controlling & reducing
conversion cost per unit produced.
 Implementing Lean Manufacturing concepts for enhancing efficiency, product robustness and reducing operational
costs. Making use of performance management to improve yield and productivity.
Team Management
 Imparting continuous on job training to the workforce for enhancing their productivity & operational efficiencies
through knowledge enhancement / skill building.
 Directing, leading & motivating workforce and imparting continuous on job training for accomplishing greater
operational effectiveness/ efficiency.
 Working on succession planning of the workforce, shift management activities, appraising the member’s
performance & providing feedback.
OCCUPATIONAL CONTOUR
Since Sept 1991 working with GlaxoSmithKline Pharmaceutical Ltd., Nasik.
GrowthPath:
Sept 1991 – Oct1997: Production Officer
Oct 1997 – Oct 2000: Production Executive
Oct 2000 – Oct 2008 : Assistant Manufacturing Manager (JMII)
Oct 2008 –Oct 2010 : Assistant Manufacturing Manager (JMI)
Oct 2010 – Apr 2014 : Manufacturing Manager (MMIII)
Apr 2014- till date : Manufacturing Manager (MMII)
Key Deliverables:
 Implementing all CGMP & FDA requirements in the department.
 Involving in various Internal and External Audits.
 Acting as Internal Auditor for conducting L1 & L2 audits.
 Part of the team for implementing Performance Management and Standard Work.
 Leading the multifunctional teams on process improvements projects.
 Coordinating with central planning for optimization of resources & matching commercial demands, procurement &
stores for material availability & lead time management.
 Validating sterile facility & equipment’s as per GSK & regulatory standards.
Significant Highlights:
 No major findings in FDA and UK audit.
 Rich experience in development of following dosage forms:
 Sterile Manufacturing & Packing – Liquid Ampoules & Dry Powder Injectable.
 Tablet Manufacturing & Packing (2.5 Billion tablets/annum).
 Handle a work force of 90 employees.
 Got 6 promotions in GSK since 1991.
 Instrumental in coordinating several projects in Glaxo Excellence Process.
 Holds the distinction of the following:
 Expert in Lean Sigma.
 Obtained Green Belt Certificate in Lean Sigma Project.
 Achieved 20% per person productivity improvements injectables.
 Yield improvements by 50% in Dry powder sterile injectable
 Successful in 100% delivery performance for Sterile.
 Won the best managed safety department trophy.
 No sterility failures.
 Molins machines replaced with R J semi automatic cartonators.
 Zinetac strips packing changed from 20 to 30 tablets per strip resulting in increased productivity.
COMMENCED CAREER
03/10/1989 to 02/10/1990: Hoechst India Ltd, Mumbai, One year apprentice.
01 /11/1990 to 19/08/1991: U S Vitamins, Mumbai, Production supervisor.
SCHOLASTICS
B.Pharm in 1989
Amravati University, Maharashtra State
Approved by FDA Maharashtra State Govt. in Sterile Manufacturing
PROFESSIONAL TRAININGS
 Glaxo Excellence Process
 Situational Leadership Training.
 Living safety training at Sonipat.
 Level -1 to Level -2 audit training
PERSONAL SNIPPETS
Date of Birth: 16th
Aug 1963
Residential Address: 4, shrimant Chintamani, B/H , P E school , Vidya Nagri, Nashik Road , Nashik ( M S)
Linguistic Proficiency: English, Marathi, Hindi and Urdu.
Location Preference: Any where in India and aboard.
S_K_Navidullah_Resume_20_15.DOC

S_K_Navidullah_Resume_20_15.DOC

  • 1.
    S K Navidullah Tel:0253-2469385  Mobile: 09552536419 E-Mail: sknavidullah@rediffmail.com Production Management Specialist With enriched experience of 25 years in managing entire Production & Quality Operations Since Sept 1991, working with GlaxoSmithKline Pharmaceuticals Ltd. a leading Multinational organisation. Qualified with extensive experience in dosage forms like sterile (21 years ) , and tablets (4 years) , worked in the field of Manufacturing Operations, Quality and Process Enhancements in the Pharmaceutical industry; taking cost- saving initiatives to optimize efficiency and enhance productivity. Presently associated with GlaxoSmithKline Pharmaceutical Ltd., Nasik as Manufacturing Manager. Holds technical competency in dosage forms of secondary pharmaceuticals manufacturing. Good in effectuating various quality standards and productivity improvement tools 5S, Lean sigma, involving resource planning, in-process inspection, team building and co-ordination with internal / external departments. Good knowledge for preparation of FDA, Group (UK), and Level-1 to Level -4 audit, an enterprising leader with the ability to motivate personnel towards achieving quality objectives and adhering to industry best practices. Effective communicator & negotiator with strong analytical, problem solving & organizational abilities. AREAS OF EXPERTISE Production Operations  Planning day-to-day strategies, budgets, manufacturing schedules, along with resource allocation and machine loading for optimum output of manufacturing division of sterile (dry powder Cephalosporin and liquid injectables) department and tablets .  Minimizing performance bottlenecks for high productivity by maximizing men, material & machine.  Appraising the prevalent manufacturing systems/ processes, identifying loopholes if any and undertaking result- oriented measures for alleviating them and documenting the same. Quality  Implementing Quality Management System (QMS), taking stringent quality measures by implementing, 5S, Living safety, Lean Sigma, at the site. Preparation of necessary documents to ensure compliance with Regulators like FDA.  Supervising CAPA teams to find out root cause & implementation of preventive measures.  Imparting on the job trainings to operators & supervisors on quality systems.  Carrying out gap analysis to bring SOP’s and BMR in line with Global Quality Policies and Global quality Management systems.  To identify training needs of management and non management staff and initiate and / or impart adequate training needs in functional, GMP and Safety aspects.  Handling of Change controls, Process Deviation Reports, CAPA and Out of Specification. Process Enhancements  Educating the personnel regarding Root Cause Analysis & CAPA Management.  Identifying scope for:  Planning / implementing technological changes to enhance efficiency.  Modifications in equipment, process flow, working practices, consumables, etc. for controlling & reducing conversion cost per unit produced.  Implementing Lean Manufacturing concepts for enhancing efficiency, product robustness and reducing operational costs. Making use of performance management to improve yield and productivity. Team Management  Imparting continuous on job training to the workforce for enhancing their productivity & operational efficiencies through knowledge enhancement / skill building.  Directing, leading & motivating workforce and imparting continuous on job training for accomplishing greater operational effectiveness/ efficiency.  Working on succession planning of the workforce, shift management activities, appraising the member’s performance & providing feedback. OCCUPATIONAL CONTOUR Since Sept 1991 working with GlaxoSmithKline Pharmaceutical Ltd., Nasik.
  • 2.
    GrowthPath: Sept 1991 –Oct1997: Production Officer Oct 1997 – Oct 2000: Production Executive Oct 2000 – Oct 2008 : Assistant Manufacturing Manager (JMII) Oct 2008 –Oct 2010 : Assistant Manufacturing Manager (JMI) Oct 2010 – Apr 2014 : Manufacturing Manager (MMIII) Apr 2014- till date : Manufacturing Manager (MMII) Key Deliverables:  Implementing all CGMP & FDA requirements in the department.  Involving in various Internal and External Audits.  Acting as Internal Auditor for conducting L1 & L2 audits.  Part of the team for implementing Performance Management and Standard Work.  Leading the multifunctional teams on process improvements projects.  Coordinating with central planning for optimization of resources & matching commercial demands, procurement & stores for material availability & lead time management.  Validating sterile facility & equipment’s as per GSK & regulatory standards. Significant Highlights:  No major findings in FDA and UK audit.  Rich experience in development of following dosage forms:  Sterile Manufacturing & Packing – Liquid Ampoules & Dry Powder Injectable.  Tablet Manufacturing & Packing (2.5 Billion tablets/annum).  Handle a work force of 90 employees.  Got 6 promotions in GSK since 1991.  Instrumental in coordinating several projects in Glaxo Excellence Process.  Holds the distinction of the following:  Expert in Lean Sigma.  Obtained Green Belt Certificate in Lean Sigma Project.  Achieved 20% per person productivity improvements injectables.  Yield improvements by 50% in Dry powder sterile injectable  Successful in 100% delivery performance for Sterile.  Won the best managed safety department trophy.  No sterility failures.  Molins machines replaced with R J semi automatic cartonators.  Zinetac strips packing changed from 20 to 30 tablets per strip resulting in increased productivity. COMMENCED CAREER 03/10/1989 to 02/10/1990: Hoechst India Ltd, Mumbai, One year apprentice. 01 /11/1990 to 19/08/1991: U S Vitamins, Mumbai, Production supervisor. SCHOLASTICS B.Pharm in 1989 Amravati University, Maharashtra State Approved by FDA Maharashtra State Govt. in Sterile Manufacturing PROFESSIONAL TRAININGS  Glaxo Excellence Process  Situational Leadership Training.  Living safety training at Sonipat.  Level -1 to Level -2 audit training PERSONAL SNIPPETS Date of Birth: 16th Aug 1963 Residential Address: 4, shrimant Chintamani, B/H , P E school , Vidya Nagri, Nashik Road , Nashik ( M S) Linguistic Proficiency: English, Marathi, Hindi and Urdu. Location Preference: Any where in India and aboard.