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Quality Manager

Location:
Smyrna, Georgia, 30344, United States
Salary:
68,000
Posted:
March 02, 2011

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CECILIA P. FOSTER

**** **** ******* *****

East Point, GA. 30344

(404) ***-****

QUALIFICATION SUMMARY

Quality Assurance Manager, with over 10 years of experience in processing, packaging and

warehousing of drug and cosmetic products. An effective leader that exhibits confidence and

extensive knowledge in quality systems regulations and operations management systems.

PROFILE

FDA 21 CFR 210/211 Visionary Leadership

cGMP /CFTA / WHO Strategic Thinking

ANSI & MAV Specifications Analytical Analysis

Quality Management Organization Support

Uses strong technical knowledge and intuition to complement data analysis for process and

quality improvements.

Comprehends organization’s strengths and weaknesses and adapts strategic plan to achieve

organization’s goals for Safety, Quality, Compliance Standards, Consumer Safety and

Customer Satisfaction.

Displays passion, inspiration and optimism to peers and subordinates to fulfill organization’s vision

for successful execution.

Train, Coach and Motivate subordinates to develop skills for professional and personal

growth and continuous improvement.

Exhibits Professionalism and tact at all times, with respect to others regardless of position.

Uses a Win – Win approach to achieve positive resolutions.

ACCOMPLISHMENTS

2008-2010

• Top Gun Outstanding Achievement Award

• Key component in successfully implementing Validation Protocol and Requirements

• Initiated and trained key personnel on Hosting FDA Inspector Guidelines

• Completed and implemented Proctor & Gamble’s 19 Quality Assurance Key Elements

• Initiated the integration of NIOXIN’S SOP’S with Proctor & Gamble’s GBU SOP’S for WQA

Compliance

• GDOL 5 Years of Excellence in Quality, Safety and Healthy Work Environment with no lost time

• Initiated and performed cGMP Training for all manufacturing personnel

• Established all requirements and protocols for SIP Audit Compliance

• Successfully implemented FDA 21 CFR 210/211 requirements and protocols for Drug

Manufacturer and QSR tracking

• Created and developed a non existing Quality Department into an Effective and Efficient Quantitative, Qualitative, Detailed Oriented Quality System to date

2005-2007

• Completed OnLine Expert Computer Training

• Successfully integrated In Process Inspection results into IFS Operating System

2000-2005

• Performed Capability Study which improve overall loss from 6% to 1%

• Initiated manual tracking system to track Actual Yields vs. Theoretical Yields

• Initiated and implemented Vendor Qualification Requirements

PROFESSIONAL EXPERIENCE

11/97- Present Proctor & Gambles GBU

NIOXIN Research Laboratories Lithia Springs, GA.

Site Quality Manager

Process Management-

• Create, develop and maintain procedures for Self Improvement Program which identifies outages and violations to Title 21 Code of Federal Regulations Parts 210 Current Good Manufacturing Practices for Packing and Holding of Drugs and Part 211 cGMP for Finished Pharmaceuticals and World Health Organization.

• Collaborated with Operation’s Management and ValidaPharm on GMP Gap Analysis Audit to identify improvement areas for compliance of Health Canada and FDA cGMP.

• Review manufacturing for process control, procedure maintenance and compliance of standards, which includes packaging, labeling operations and testing of drug and cosmetic products.

• Establishes and maintains all quality standards, sampling guidelines and inspections required assuring that In Process and Finished product meets compliance and technical standards.

• Collaborate with Technical Standards (R&D) to assure product’s life cycle meets all compliance and regulatory requirements throughout product supply chain.

• Assures that procedures are in place and maintained for IQ, OQ and PQ for equipment and process validations.

• Create, develop and maintain procedures for lot tracking for product traceability.

• Create, develop and assures procedures are in place for Quarantine and Release of In Process and Finished goods

• Analyze data to identify trends, yields and deviations for QSR report and make recommendation for quality improvements.

Training and Personnel Qualifications-

• Trains all Quality personnel, Operations Management and Manufacturing personnel on P&G’s 19 Key Elements, FDA, cGMP and CTFA requirements.

• Assures that written procedures are in place and are maintained for all training and qualifications for all manufacturing and quality personnel.

• Monitors and reviews training of personnel to assure there is sufficient number of personnel to perform and supervise the manufacture of drug and cosmetic in process and finished goods products.

Document Management and Reporting-

• Create and maintain Site Plan and Hosting FDA Inspector Protocols

• Document and maintain SOP for testing, packaging and labeling of in process materials and distribution of finished goods

• Maintain Training and Qualification documentation.

• Create and maintain Change Control documents for specifications and quality improvement.

• Create and maintain CAPA, Quality Performance, OOS and Certificate of Analysis reports for in process materials and finished goods.

EDUCATION & TRAINING

Clark College Atlanta, GA.

Business Administration

Fulton High School Atlanta, GA

Diploma

TQM Training Statistical Process Control Training

ISO 9000 Training Teamwork Management Training

NIOXIN Management Training



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