LENKA SMALCOVA

200 W. Webster Ave, Apt.D-10, Roselle Park, NJ 07204 (c) 908-494-7963 (h) 908-24
5-6097
Email: ls97a0d8@westpost.net
PHARMACEUTICAL PACKAGING SUPERVISOR
TEAM LEADER
MACHINE OPERATOR
EXECUTIVE SUMMARY

Innovative, assertive and goal oriented Pharmaceutical Packaging Supervisor/Team

Leader/Machine Operator who offers a distinguished background of successfully l
aunched and managed packaging shift operation and initiatives that spur operatio
nal growth and profitability. Outstanding ability to effectively identify opport
unities, develop focus and provide tactical solutions.
CORE COMPETENCIES

* Strategic Planning & Organizational

* Staff Training & Workforce Planning
* Operational Streamlining
* Coordinate continuous improvement
* Quality Control & Regulatory Compliance
* Team Leadership & Motivation
* Special Project Management
* Develop work plans and coordinated logistics with the support of each team mem
ber
* Key-player on inter-departmental team that modified process through tablet des
ign, eliminating breakage, packaging configuration

RECENT EMPLOYMENT EXPERIENCE

SUN PHARMACEUTICALS, Cranbury, NJ 2008-Present
Pharmaceutical Packaging Supervisor
14 Direct Reports
High profile Supervisor charged with commanding quality assurance to control pha
rmaceutical packaging operations in conjunction with compliance with FDA require
ments, cGMP, OSHA, SOPs, 21 CFR 210 & 211,Plant policies and working practices.
* Prepare and execution of validation processes
* Prepare and execution of performance qualification protocols
* Prepare documentation and execution of exhibit & bioequivalence batches
* Supervise and monitor packaging operation for DEA products
* Supervise and train packaging personnel and machine operators in compliance pr
ocesses and procedures
* Supervise and train personnel for overall adherence and implementation of the
process
* Prepare, execution and review of packaging master records, assure batch record
s are accurate and complete
* Perform visual and metal inspection on bulk products before proceeding for p
ackaging
* Perform and document in-process checks on packaging lines during entire packag
ing operation including AQL inspection on bulk product or finished product
* Assist in monitoring conformance to current specification for all finished pro
duct and components
* Responsible for completing and/or assisting in the investigation process. This
 includes writing data collection for investigations and offering technical supp
ort to others of operations.
* Assist in initiating and reviewing all change controls and planned deviations
for Quality approval
* Spot check cleaning technician and cleaning procedure
* Assure appropriate procedures for batch record review are understood and consi
stently followed
* Create and revise SOPs, working instructions and procedures
* Consistently meet or exceed production goals by improvements on packaging line
s to ensure smooth functioning of the process
* Investigate all issues as well as CAPA involving packaging process and equipme
nt
* Engage in problem solving with Technicians to resolve issues impacting the day
-to-day operation
* Develop and enforce operational safety program
* Identify and discuss significant process improvements with Team members and Te
chnical service group
* Achieve targeted goal within prescribed time frame to build up inventory
* Effectively operate and trouble-shoot packaging equipment and any operational
issues at timely manner
* Record and maintain Work order, Inventory and Preventive Maintenance documenta
tion
* Develop work plans, coordinate and order required machine parts, equipment, vi
sion systems, testing devices.
* Support and execution of operation qualification, installation qualification,
performance qualification, validation and other supporting activities
* Execute cleaning validation for packaging line, ensuring effectiveness of clea
ning procedure
* Responsible for operating, training, setting up and troubleshooting of follow
ing equipment:
* Unscrambler AU6-C
* Gorge Placing System Pouch Dispenser PPS 250
* King SC12 Slat Counter, EC 12-electronic counter
* King Cottoner
* Kaps All Capper, Diagnostic Center, Induction sealer
* Quadrel Versalin Labeling System
* Allen Bradley Panel View 300 Micro Lot and bar code
Verification system
* MG 5 Machine Corporation Pick and Place Outsert
* Little David LRD Case Sealer

TESTPAK, Whippany, NJ 2005-2008

Pharmaceutical Packaging Supervisor
100 direct reports
Supervisor promoted to direct quality of pharmaceutical packaging operations at
two facilities. Evaluated and approved packaging operations, and controlled docu
ments including SOP's master and executed packaging records,
* Ensured accurate, efficient and timely product packaging-from requisition to f
inished goods completion
* Managed day-to-day packaging operations, directing staff to achieve quality an
d output requirements
* Scheduled production balancing capacity constraints and customer needs
* Minimized production equipment down-time
* Overall responsibility for production from scheduling through packaging and fi
nished goods completion
* Prevented potential cross-contamination by identifying, documenting and sealin
g hiding spots for foreign tablets in modules and equipment
* Effectively trained a staff of operators, clerks, helpers on SOPs, plant polic
ies ensuring 100 % training compliance with FDA requirements
* Ensured packaging process controls were followed appropriately
* Coordinated timely and effective communications with team members to ensure bu
siness needs were met
* Delegated work of the team to ensure milestones were achieved
* Investigated all issues as well as CAPA involving packaging process and equipm
ent
* Engaged in problem solving with Technicians to resolve issues impacting the da
y-to-day operation
* Effectively troubleshot and solved operational issues
* Devised and implemented a check list for operators for catching in-process doc
umentation errors resulting in improved documentation
TESTPAK, Whippany, NJ 2005-2006
Team Leader
36 Direct Reports
As Team Leader, accountable for overseeing of packaging operations on designated
packaging lines.
* Maximized production efficiency and minimized defects for team
* Supervised and balanced production staff including: operators, packers and mas
sagers according to production schedule
* Optimized production efficiency by minimizing reconciliation, clearance, and s
hipper label wait-time
* Accurate and timely reconciliation, line clearance and shipper label preparati
on
* Ensured finished goods meets regulatory and customer quality requirements
* Performed in-process checks from raw material receipt to final shipping to ide
ntify errors as close to source as possible
* Incoming product, line start-up, in-process and finished goods documentation a
nd verification
* Managed FDA-regulated drug label inventory
* Received, issued and reconciled labels to support production activities
* Maintained required documentation and communication to ensure accurate invento
ry and timely delivery.
TESTPAK, Whippany, NJ 2003-2005
Machine Operator
Machine Operator on various packaging lines responsible for cleaning, setting up
, troubleshooting and operating the following machinery:
* Jones Cartoner with Autotech Controls for Nordson Vista G
lue
Tank
* Hitachi PX Ink Jet Printer
* Heat Tunnel, Shrink Wrapping (L sealer)
* Ceco Cartoner Glue Machine, Scandia Cartoner Gluer with

PL-S Electro Cam One Touch barcode scanner

* Hapa Matic Printer, Hapa Printer 226 UV Lamp
* Bivans Cartoner- Debosser, Prodo Pak pouch, Alloyd
* Outserter M.G.S. Thiele 34000
* Slat Counter SC4, Lakso 450.93
* Cozzoli rotaro electronic counter T4-23
* Cotton inserter CLI 110, Lakso 52, E-King 100 R
* Mac Blister machines with hydraulic system for cold formi
ng
* Blipack Blister machines with hydraulic system for cold
forming
* P.S. Label machines: Quadrel 1000, UNI 500, DL TECH
* Kaps All capper.
PREVIOUS EMPLOYMENT EXPERIENCE
 Teacher Mechanical Engineering: SECONDARY MECHANICAL SCHOOL, 2001-20
03
VRANOV NAD TOPLOU, S
LOVAKIA
EDUCATION AND PROFESSIONAL DEVELOPMENT
Mechanical Engineer, major in Environmental Science, Technical University, Kosic
e, Slovakia, 1999
Trainings completed: Hazardous Waste Management, Fire extinguisher, Hazard Commu
nication Program (General), c GMP, Waste regulatory, Lean Manufacturing,
Technical skills: Proficient in MS Office tools: Outlook, Excel, Word, Power Poi
nt, Windows, Lotus, ERP, Fourth Shift