Pharmaceutical Operations/Production/Team Leader/Machine Operator/Pack

QUALIFICATIONS OVERVIEW

Remarkably astute, competent, and talented senior executive powered with broad-based years of comprehensive achievements within Pharmaceutical Packaging Operations and Production Processes. Excel in applying state-of-the-art concepts to reduce costs while optimizing efficiency, productivity, and profitability. Possess stellar reputation in developing performance-based, cost-effective solutions through comprehensive skills in incorporating innovative management techniques that result in enhanced business practices. Show paramount efforts in operating and troubleshooting on bottle filling equipment as well as in leading cross-functional teams and completing projects within time and budget constraints. Establish long-term quality relationships focused on teamwork, service level, and cost containment. Proven ability in working effectively even in fiercely competitive, challenging, and stressful situations.

AREAS OF EXPERTISE

 Production Management and Operations  Quality Assurance and Industry Best Practices

 Cost Optimization and Budget Control  Strategic and Tactical Planning

 Leadership, Training, and Team Building  Superior Interpersonal and Presentation Skills

 Time Management and Prioritization  Continuous Process Improvement

 Problem Resolution and Decision Making  Organized with Strong Analytical Abilities

 Articulate Oral and Written Communication  Multitasking in Fast-Paced Environments

EMPLOYMENT HISTORY

SUN PHARMACEUTICAL USA  CRANBURY, NJ

PHARMACEUTICAL PACKAGING SUPERVISOR 2008–PRESENT

Direct and coordinate daily aspects of the business focused on quality assurance of pharmaceutical packaging operations for DEA products. Ensure strict with compliance with FDA requirements, cGMP, OSHA, SOPs, 21 CFR 210 & 211, plant policies and working practices. Prepare and execution of validation processes; performance qualification protocols; including exhibit and bioequivalence batches. Facilitate training to 18 packaging personnel and machine operators in compliance processes and procedures. Carry out in-process checks on packaging lines during entire packaging operation including AQL inspection on bulk product or finished product. Instrumental in completing the investigation process: writing data collection for investigations and offering technical support to others of operations. Coordinate and order required machine parts, equipment, vision systems, testing devices. Work collaboratively with Research and Development Department to define best packaging configuration.

Notable Accomplishments:

• Conceptualized and modified SOPs including working instructions and procedures toward fulfillment of corporate goals

• Greatly surpassed production goals by improvements on packaging lines to ensure smooth functioning of the process

• Played a vital role in investigating all issues as well as CAPA involving packaging process and equipment

• Initiated the development and implementation of operational safety program

• Determined significant process improvements with team members and technical service group and held responsible for addressing day-to-day issues and concerns

• Recognized for operating, training, setting up and troubleshooting 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, and Little David LRD Case Sealer

TESTPAK  WHIPPANY, NJ: 2003–2008

PHARMACEUTICAL PACKAGING SUPERVISOR 2006–2008

Expertly managed the quality of pharmaceutical packaging operations at two facilities consisting of 100 employees to achieve quality and output requirements. Evaluated and approved packaging operations, and controlled documents including SOP’s master and executed packaging records. Trained a staff of operators, clerks, helpers on SOPs, plant policies ensuring 100 % training compliance with FDA requirements. Spearheaded staff, delegated specific responsibilities, and regularly communicated with team members to ensure business needs were met. Assumed full responsibility in investigating all issues as well as CAPA involving packaging process and equipment.

Notable Accomplishments:

• Rose from rank and promoted to much higher position through demonstration of exemplary performance and high degree of personal commitment

• Ensured accurate, efficient and timely product packaging from requisition to finished goods completion

• Minimized production equipment down-time by ensuring packaging process controls were followed appropriately

• Prevented potential cross-contamination by identifying, documenting and sealing hiding spots for foreign tablets in modules and equipment

• Improved documentation by devising and implementing a a check list for operators for catching in-process documentation errors

PHARMACEUTICAL PACKAGING TEAM LEADER 2005–2006

Provided expert oversight to day-to-day facets of packaging operations on designated packaging lines consisting of 36 direct reports. Handled incoming product, line start-up, in-process and finished goods documentation and verification. Oversaw FDA-regulated drug label inventory and accountable for receiving, issuing and reconciling labels to support production activities. Maintained required documentation and communication to ensure accurate inventory and timely delivery.

Notable Accomplishments:

• Optimized production efficiency and minimized defects including for team by employing exceptional leadership skills

• Mentored production staff including: operators, packers and massagers according to production schedule

• Ensured accurate and timely reconciliation, line clearance and shipper label preparation in accordance with FDA,DEA,OSHA and customer quality requirements

• Executed in-process checks from raw material receipt to final shipping to identify errors as close to source as possible

PHARMACEUTICAL PACKAGING MACHINE OPERATOR 2003–2005

Notable Accomplishments:

• Played a vital role in cleaning, setting up, troubleshooting and operating the numerous packaging machinery such as Jones Cartoner with Autotech Controls for Nordson Vista Glue 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 forming, Blipack Blister machines with hydraulic system for cold, forming, P.S. Label machines: Quadrel 1000, UNI 500, DL TECH, and Kaps All capper

• Recognized as the “Best Machine Operator” in the plant for being dedicated and precise as well as by continuously meeting production goals with maximum quality

PRIOR WORK EXPERIENCE

MECHANICAL ENGINEERING TEACHER

 Secondary Mechanical School, Vranov Nad Toplou, Slovakia: 2001–2003

EDUCATION

MASTER IN MECHANICAL ENGINEERING, MINOR IN ENVIRONMENTAL SCIENCE, GPA: 3.6

 Technical University, Mechanical Engineering, Kosice, Slovakia: 1994–1999

PROFESSIONAL TRAINING

Hazardous Waste Management | Fire extinguisher | Hazard Communication Program (General) | GMP | Waste regulatory | Lean Manufacturing

TECHNICAL PROFICIENCY

MS Office Suite: Outlook, Excel, Word, PowerPoint, including Lotus, ERP, and Fourth Shift

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