Manager Process Improvement
Resume:
Satya Mantha
Etobicoke, Toronto, ON, M9W 0A4
Ph: 416-***-****
Email: ************@*****.***
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OBJECTIVE: Seeking a Suitable position to support Manufacturing Operations
of Pharma/Biotech Industry.
PROFESSIONAL EXPERIENCE:
SUPERVISORY SKILLS:
. Directed workflow and supervised group leaders,
operators, packaging technicians and mechanics.
. Trained staff and Managed On the Job Training records
of staff
. Reported Management of daily activities by shift
reports, incident reporting and actions taken
. Coordinated on Emergency procedures during Fire Alarm
and HSE issues
. Worked on annual budget for staffing and resources
. Coordinated for HVAC, Electrical and EM issues
. Worked On Planned and Unplanned shutdowns
. Worked on planning schedules with logistics
. Reviewed BPR, validation records and SOP's.
. Reported variances in production through puts by OEE
system
. Developed Performance management of staff, supported
staff on training and development.
. Developed Shift reports and OEE reports for the team
PROCESS SKILLS:
. Supervised formulations, filling and packaging
operations of Sterile and Solid dosage
Manufacturing operations .
. Worked on Clean Room Techniques and Procedures
. Worked on Process improvement for Aseptic Operations.
. Coordinated on development of batch records for Right
the First Time.
. Worked on scale up stage of sterile formulations,
solids and liquid formulations
. Coordinated in Change control procedures for Aseptic
filling and packaging operations
. Worked on 5S & Overall Equipment Efficiency(OEE) of
Aseptic Filling Line, labeling Packaging Lines. (
vial tunnel, Libra & Wieler labeling,CAM & Marchesini
Packaging lines).
. Knowledge of cGMP systems based on FDA guidelines
. Worked on SAP for operations
TROUBLESHOOTING SKILLS:
. Worked on Root Cause Analysis for Non-Conformance
events and Environmental Investigational reports,
Met 95-100% target of Non-Conformance reports.
. Coordinated Change control procedures for
Formulations, Filling and Packaging operations
. Coordinated in addressing FDA/Health Canada Audit
comments
. Participated in Root cause analysis of HSE matter
incidents
. Worked on Aseptic filling issues of bulk tank
connections
. Worked and coordinated on vial tunnel glass particle
root cause investigations
. Worked and coordinated on group classification of
defects in aseptically filled containers(vials).
EDUCATIONAL QUALIFICATIONS:
1985: B.PHARM
Bachelor of Pharmacy, Andhra University
Vishakapatnam, Andhra Pradesh India.
Accredited to in level to Bachelor's Degree, Specializing in
Pharmacy.
University Of Toronto - Comparative Education Service.
1991 : PG Diploma in Business Administration from AP Productivity
Council Hyderabad India
2011 : Registered for Green Belt Training program for continues
improvement.
EMPLOYMENT HISTORY:
2005 - 2010: Manager - Formulations Filling and Packaging : Sanofi
Pasteur, Toronto, Canada [ Unionized work environment]
. Supervised Midnight and Afternoon shift operations
. Lead the team for "Right the First Time" project for reconciliation
of batch production records. Reviewed BPR, SOP's and validation
BPR's.
. Trained and Developed staff on Vial Tunnel, labeling & Packaging
operations
. Worked on Non-Conformance investigations and root cause analysis.
. Coordinated and worked with QO in Non Conformance investigations
. Worked and Coordinated in Planned and Unplanned Overtime / shut
down schedules ( Quarterly HVAC and half yearly Electrical shut
downs)
. Worked with logistics on everyday scheduling and weekend work
. Worked and Coordinate on Vial tunnel process improvement project
. Worked on Process improvement for Labelling & Packaging Lines
. Participated in implementation of Overall Equipment Efficiency(OEE)
& 5S project and training of staff on OEE aspects.
. Coordinated in change control procedures
. Basic knowledge of six sigma project
. Coordinated in validation studies of labeling and vial tunnel line
. Reported Management on daily shift outputs, variances, incidents
and action taken.
2001 - 2004 : Production Manger with Pangeo Pharma(Canada) Perth
Plant, Perth ON Canada.
[ Non Unionized work environment]
. Worked on production and development of Tablets and Caplets
. Coordinated in developing GMP systems (Creation and Management of
Standard Operating Procedures and developed SOP's for Production
operations )
. Supervised production operations and Coordinated in Training and
development of staff. Participated in Budgets
. Participated in Self Audit as per procedures.
. Worked on writing of Non Conformance events and coordinated in
investigation.
. Worked as AQPIC of controlled formulations.
. Reported Management on daily out puts and issues and supported
Plant Management issues in the absence of Plant Manager
1994 - 2000 : Deputy Manager Production --Biological E Ltd. Hyderabad
India
[ Unionized work environment ]
. Supervised production and packaging of Aseptic operations(Biological
products)
. Worked and Coordinated on process development of Aseptic Filling,
capsules and Packaging operations
. Coordinated with Quality Control and Assurance for testing matters
. Coordinated in unplanned and planned schedules for operations
. Prepared Annual Budget for production and packaging operations
. Supported sterile operation project
. Trained on clean room behavior, techniques and process
1989 - 1994 : Production Executive, Jasper Labs Pvt., Ltd. Hyderabad
India
. Formulated solid dosages (Capsules, Tablets) and Supervised
Production operations
1986 - 1989 : Manufacturing Chemist, SOL Pharmaceuticals Ltd.,
Hyderabad India.
. Supervised, Capsules, Liquid filling and packaging operations
. Coordinated in Liquid transfer technology
1985 - 1986 : Apprentice, Hoechst India Ltd., Mumbai
India
. Trained on Aseptic Manufacturing operations
CITIZENSHIP: CANADIAN
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