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Compliance Specialist / Manufacturing Supervisor Resume

Caguas P, R

SUMMARY

  • Over twenty - five (25) years of experience supervising processing operations in the pharmaceutical / manufacturing industry.
  • Well experienced in electronics Batch Records Authoring, Confidential Systems (PMX).
  • Proven attributes in visionary and innovative thinking leading to practical applications in the delivery of products and services.
  • Strong background in Deviation Reports Investigations, Training Developer, Auditing, Validations, Certifications, Quality Assurance, Sanitization Techniques, Solid / Parental Manufacturing and Electronic Batch Record Design.
  • Increased Service Level from 96.5% to 99.1%
  • Saved in cost by over $700,000 in materials usage per year.
  • Established procedures to minimize defects that improved Quality Index from 95% to 98%.
  • Established a reduced sampling plan resulting in a reduction of approval lead-time: three days reduction.
  • Participated in ISO 9002 certification process as part of the production team assigned to revise procedures, conduct audits, and represent organization during certification audits; successful certification was obtained.
  • Honored as recipient of the Excellence Award, while acting as director for Packaging Department Safety Program.
  • Directed the implementation of High Performance Team that increase efficiency (55% to 88%), effectiveness (93% to 98%) and personnel motivation (absenteeism rate from 3% to 1%)
  • Reduced documentation errors by 50% due to Batch Record Simplification Project implementation.
  • MES Carolina Team ( Confidential ) recognized as the most efficient in the Corporate MES Implementation Initiative.
  • 100 % manufacturing operators training completion through an entire year (3 times).
  • Increase net yield by 1%. Represented to Formulation Department a cost saving over $800,000.
  • Reduced Formulation Deviations related to job performance by 75% through an entire year.
  • Increase by 25% the equipment sterilization capacity.
  • Reduced Filling Department downtime related to sterilized equipment availability by 20%.
  • Eliminate stoppers mixed up in the Fedegari stoppers washing and sterilization machine.
  • Implement Seal Force Monitors. This exercise included FAT, SOP’s creation and training design.
  • Sealing assessment to identify Media Fill failures and implement corrective actions to obtain three consecutive successful results.
  • Increase 25% tablet production compressing capacity without personnel addition.
  • Selected as Visual Aids Manufacturing Team Resource (FDA Response Team Site Certification).
  • Team Member of MES Confidential Barceloneta, during the implementation of Corporate PMX & Global Project.
  • Team Member of Pharma Suite Confidential System Implementation as recipe author and manufacturing support in Confidential Barceloneta during the system global implementation.
  • Reduced Human Error Manufacturing Deviations by two consecutive years (2015-2017).

TECHNICAL SKILLS

  • PMX
  • MES
  • MS Word
  • MS Excel
  • MS Power Point
  • Internet
  • Complaints
  • Manufacturing Deviations/CAPA’s
  • SOP’s
  • Change Controls

PROFESSIONAL EXPERIENCE

Confidential, Caguas, PR

Compliance Specialist / Manufacturing Supervisor

Responsibilities:

  • Annual Product Review Authoring
  • Stability / Product Trend Data Analyst
  • Supervise solid dose operations
  • Deviations / Non-Conformances / Investigations
  • Coordinates Third Shift Activities (staff: 25 operators & mechanics)

Confidential, Barceloneta, PR

MES Sr. Consultant

Responsibilities:

  • Electronic Batch Record Recipes Author.
  • Developing and execution of Validation Protocols, Amendments and Deviation Reports.
  • Creation of SOP’s for Electronic Batch Record Disposition according Quality Compliance.

Confidential, PR

Manufacturing Supervisor

Responsibilities:

  • Responsible of the Third Shift’s scheduling, training and production performance.
  • Trained Manufacturing Second Shift Supervisor (Operational and Administrative tasks).
  • Prepares manufacturing Monthly Schedule base on Logistic Department requirements.

Confidential, Carolina, PR

Manufacturing Supervisor

Responsibilities:

  • Design and create Electronic Batch Record using Confidential Automation PMX MES.
  • Responsible for the organization and coordination of the daily activities in the Equipment Preparation, Formulation and Sealing Departments in Aseptic / Non Aseptic Areas.
  • Design sterilization loads and coordinates sterilization process validations.

Confidential, Vega Baja, PR

Manufacturing & Packaging Supervisor

Responsibilities:

  • Responsible for all materials transaction from the Warehouse to the Floor stock (SAP).
  • Supervises the processing operation including the chemical weigh, granulation, blending, capsule filling, compressing, coating and printing.
  • Supervised and coordinated Ethical and O.T.C packaging lines (blisters & bottles) within the Pharmaceutical, Manufacturing Division (staff 64 operators and 5 mechanics).

Confidential, Manatí, PR

Manufacturing Supervisor

Responsibilities:

  • Insured compliance with federal/state regulations (FDA, DEA, others).
  • Supervised eight Operation Lines and Label Room (staff 50 operators/4 mechanics).
  • Designated as Acting Plant Manager for second and third shift operations.

Confidential, PR

QA Supervisor

Responsibilities:

  • Validated all documentation generated by Manufacturing / Quality Control Departments.
  • Responsible for disposition of Raw Materials, Bulk Products, Packaging Components, Product Intermediates, Finished Products Water and Environmental Systems.
  • Performed audits and training to insure FDA Regulations and Company Polices.
  • Conducted complaints investigations identify cause and recommend corrective actions.

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