QA Change Management

Rasina Ramirez

acs20i@r.postjobfree.com

QUALIFICATIONS

Project Management: Led 8D process and various Continuous Improvement projects

Team Leadership: Process Trainer and 8D Champion

Customer Orientation: Pioneered strategic relationship management program with customers concerning quality issues and corrective action plans

EMPLOYMENT

Mar 2013-Current Senior QA Systems Leader, Proctor & Gamble (dual role)

Change Control Management Leader

Manage and execute the Change Quality Systems,

QA Validation support for lab equipment/system validations/installation

Review and approve standard changes

Conduct periodic reviews of supplier qualifications, change control, EO’s, validations

Ensure all change quality systems are compliant with FDA, global and national laws and regulations

lead change management activities

Administer Site Change Control Requests from submission to implementation

Lead efforts in performing change management assessments, assessing the impact change would have on existing products, processes, and procedures

Schedule and lead change management review board, engaging area risk leaders in the review, assessment, and disposition change controls

Prepare data for management and Monthly Quality Council review on change request trends and metrics

Determines follow up actions and implements corrections and improvement in the change control process

Manage change control documentation through applicable document retention policies (electronic / hard copies)

Manages review and assessment of process and equipment changes

Responsible for assigning applicable validations and protocol for change control execution

Responsible for the final approval and implementation strategy of changes

Responsible for Metrics tracking of change controls and validation

Responsible for maintenance, generation and revision of applicable SOPs (Standard Operating Procedures)

Mar 2013-Current QA/Regulatory Trainer, Teva Pharmaceutical/Proctor & Gamble

GMP Trainer

Trained site on regulatory compliance

Implemented job specific qualification and step up system

Ensure all employee are compliant with FDA requirements for procedures, processes, documentation

Worked with Site Management in implementing continuous improvement enhancements to existing training programs.

Instrumental in the implementation and primary administrator of computerized (LMS) Learning Management System

Conduct GMP and GLP training as per FDA Requirements

Instrumental in the development of computerized Training records

Responsible for GMP on boarding of new employees

Responsible to ensure GMP training is current and compliant with FDA regulations for all employees

Mar 2009-2013 Senior QC Chemist III, Banner Pharmacaps

Testing Raw materials and finished products per HPLC, GC, quantitative analysis, strength, impurities and identification

Executed protocols for effectiveness and safety before commercialization of potential drugs for human clinical trial per R&D

Executed R&D protocols associated with drug development and processing

Trouble shooting analytical instrumentation

Accurately, clearly, and completely communicate and document results

Developed test procedures and work instructions

Executed LIR’s and CAPA system

Actively review data prior to release for error

Develops method templates and atlas report templates

Performs method evaluations

Team leader for lack of advancement committee

Train and mentor qc personnel on complex wet chemistry

Develop, implement, and execute training protocols

Train QC personnel on lab instrumentation (HPLC, GC, KF,GMP documentation

Executed cleaning validations

Active member of Communication Improvement committee

Feb 2008 – Nov 2008 Quality Manager, Ameriform Companies

Responsible for the overall costs of the Quality Department

Managed QC technicians

Responsible for establishing, implementing, and directing quality control efforts to ensure that requirements for processing components and other materials into finished goods and products conform to quality standards.

Responsible for training personnel on laboratory procedures and instrumentation use

Monitors quality system trends using process control methodologies and identify and communicate negative trends

develops improvement actions and ensures proper root cause analysis and corrective actions

Identify system-wide root causes

Manages the Corrective and Preventive Action System (CAPA)

Develop and maintain product control plans and associated work instruction for receiving inspection, performance testing, and manufacturing.

Communicate results of audits and testing, both in writing and verbally, to all levels of associates within the facility.

Actively participate in continuous improvement activities.

Maintain the non-conforming material system and actively participate in the disposition of non-conforming materials.

Initiate and coordinate projects to improve process and product quality including design of experiments

Coordinate activities of the facility quality auditors.

Create and maintain positive relationships with sales team members and customers

Support multiple customers and their quality systems.

Facilitates continuous education and training to others of Quality policies and procedures.

Oct.2006- Jan 2008 Quality Technician, Perrigo Corporation, (temp)

Compliance to current standard operating procedures (SOPs) and current

Good Manufacturing Practices (cGMP), and FDA regulations

Solution preparation, Test in-process and finished products,

Test and identify raw materials, Send samples to outside laboratories for testing,

Verify logbooks and testing sheets,

Evaluate / trial newly developed analytical procedures, certification and release of production batches.

Document and retention control.

Nov. 2002- Aug.2005 HPLC Professional, Pfizer

HPLC analysis for OTC and in process pharmaceuticals product,

Developed and revised SOP’s and quality documentation

Maintained calibration logs,

Completed process and product validations on in process goods and finished goods.

Completed follow-ups and launched corrective actions for internal audits

Maintained accurate data and test results supported by GMP practice,

Implemented record retention procedures and controls as a trained record checker.

Provided training on proper GMP documentation

Provided troubleshooting and root cause analysis for HPLC systems and data collection

Conformed to strict FDA and GMP guidelines for sample submission and record keeping procedures.

EDUCATION

1992-1993 Chemical Engineering, Michigan State University

1994-1998 Biology Science BS, Grand Valley State University

PERSONAL QUALIFICATIONS

Jan 2000-current CEO Soul Elegance Catering and Event Planning

Owner and manager of family owned café & catering company. I personally provide special occasion event and meal planning. In addition to organizing and preparing all meals, I over seeing all service operations of a 5 person crew. Maintain adherence and compliance to Food and Safety Regulations and Procedures.

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