Process Improvement Quality Control
Resume:
Satya Mantha
Etobicoke, Toronto, ON, M9W 0A4
Ph: 416-***-****
Email: ************@*****.***
_____________________________________________________________________________________
OBJECTIVE:
Seeking a Leadership position to support Manufacturing and Quality Operations of Pharma/Biotech Industry.
PROFESSIONAL EXPERIENCE:
PROCESS SKILLS:
Production :
• Supervised Solid Dosage(Tablets, Capsules)operations.
• Supervised Aseptic Formulations Filling and packaging operations.
• Supervised Syrup preparation , filling and packaging lines
• Supervised Labeling and Packaging Lines.
Validation &
Process Improvement:
• Worked on Clean Room Techniques and Procedures
• Worked on Process improvement for Aseptic Operations.
• Worked on process Validations of Tablets, Aseptic filling inspection and labeling line
• Coordinated on development of batch records for Right the First Time.
• Coordinated in Change control procedures for Production 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 Health Canada and FDA guidelines
Equipment Knowledge:
• Aseptic Operations : Bosch and Strobe Fully Automatic filling and inspection line, Pressurized tanks , Fedagari Autoclave,
• Solid Dosage : Roto Granulators, Gral Mixers, Fitz mill, Compression Machines(Manesty and Cadmach 45 , 27 and 16 station), Double cone and V blenders, Coating equipment, Cadmach Semi Automatic capsule filling machine
• Liquids/Syrups : Pharmalab Semi Automatic Filling and Packaging line, Mill
• Packaging Lines : CAM, Marchesini, Libra , Wieler, Bottle packaging and Noak and Precession Gears Blister packaging lines
INVESTIGATION AND QUALITY SUPPORT:
• Worked on Root Cause Analysis for Non-Conformance incidents and Environmental Investigational reports.
• Coordinated Change control procedures for Formulations, Filling and Packaging operations
• Coordinated on CAPA’s
• Coordinated in addressing FDA/Health Canada Audit comments
• Worked on Tablets and Capsules production troubleshooting investigations
• Worked and coordinated on vial tunnel glass particle root cause investigations
• Worked and coordinated on group classification of defects in aseptically filled containers(vials).
MANAGMENT SKILLS:
• Supervised group leaders, operators, packaging technicians and mechanics.
• Supported Training programs for the team and coordinated for maintaining On the Job Training records.
• 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 Batch Production Records, validation records and SOP’s.
• Reported variances in production & Packaging operations by OEE system
• Evaluated and Developed Performance management of staff.
• COMPUTER SKILLS:
Worked on SAP modules for Production and Quality
Trained on ERP module for Manufacturing
Worked MS office Word, Excel and assisted on Power Point presentation.
Worked on Documentum
Trained on Train Track for training modules
Worked on Kronos time management
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 Program
EMPLOYMENT HISTORY:
2011 Oct Cont.: Sr. Supervisor – Granulation : Sun Pharma USA ( Caraco Pharmaceuticals Ltd.) Detroit MI USA.
• Reviewed Batch Production records
• Participated in process validation of Carvedilol tablets
• Coordinated in incident investigations
• Trained on ERP , Train Track and Kronos time managment
• Supervised unionized staff ( 14 operators )
2005 – 2010: Manager - Formulations Filling and Packaging : Sanofi Pasteur , Toronto, Canada [ Unionized work environment]
• Coordinated and 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
• Coordinated in CAPA projects
• Coordinated and worked with QO in Non Conformance investigations and root cause analysis
• Coordinated in review and addressing of FDA/Health Canada audits.
• Worked and Coordinated in Planned and Unplanned HVAC / Electrical shut downs
• Worked with logistics on everyday scheduling and weekend work
• Worked and Coordinated 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 and Self Audit of shift operations
• 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.
• Supervised 10 filling operators, 10 packaging operators, 2 group leaders, 2 mechanics, during H1N1 and Flu projects supervised 2 supervisors and 20 contact operators
2004 – 2005 : Group Leader – Trillum Health Care Brockville Ontario, Canada.
• Supervised Tablet operations
• Trained on JDE and Production reporting systems
• Worked with unionized staff ( 10 operators )
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 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
• Supervised 2 supervisors, 15 production and packaging operators
1994 - 2000 : Deputy Manager Production --Biological E Ltd. Hyderabad India
[ Unionized work environment ]
• Supervised production and packaging of Aseptic operations(Biological products)
• Supervised Production operations of Capsules and Ointments
• Worked and Coordinated on process development of Aseptic Filling, 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
• Supervised 2 supervisors, Line Leaders, and 30 packaging and filling operators
1989 – 1994 : Production Executive, Jasper Labs Pvt., Ltd. Hyderabad India
• Formulated solid dosages (Capsules , Tablets) and Supervised Production operations
• Supervised and worked on Blister Packaging Lines
• Developed Oral Rehydration Salts for general market and state government
• Coordinated with Quality Control for testing at various stages of development
• Coordinated with Marketing for product information and supported Marketing for proof reading of Product literature and in preparation of visual aids.
• Supported Managing Director for on Site Management
• Supervised 2 group leaders and 10 production operators
1986 – 1989 : Manufacturing Chemist, SOL Pharmaceuticals Ltd., Hyderabad India.
• Supervised, Capsules , Liquid filling and packaging operations
• Coordinated in Liquid transfer technology
• Worked on Blister Packaging Lines
• Supervised group leader and 25 filling and manufacturing operators
1985 – 1986 : Apprentice, Hoechst India Ltd., Mumbai India
• Trained on Aseptic Manufacturing operations
• Trained on Solid Dosage operations
• Trained cGMP procedures
CITIZENSHIP: CANADIAN
Contact this candidate