Technical Writer , Quality Assurance Specialist

FARAH E RIZVI

**** ********** **, *** ****, Houston TX 77030

CELL #: 1-732-***-****

E-MAIL: ********@*******.***

SUMMARY OF WORK EXPERIENCE

Seatex Ltd

Department of Quality Assurance, Rosenberg, Texas

January 2010 to date

Quality Assurance Technical Writer

Seatex Ltd is a leader in providing turnkey chemical compounding, toll manufacturing and private label packaging services. Its areas of expertise include the food service, food processing, automotive, institutional and industrial laundry, janitorial, industrial and oilfield service markets. Seatex can manufacture and package to strict specifications, duplicate formulas, or make available its own 400 plus finished formulations.

Responsibilities:

Working as a Quality Assurance Specialist/Technical Writer, I am responsible for putting together a GMP program for a new product launch. This involves:

· Development of GMP training requirements and strategy across all GMP impacting areas of the organization, not limited to manufacturing plant, and labeling and packaging division

· Writing Quality policies and plans.

· Documentation of all standard operating procedures pertaining to a new product launch, HAND ANTISEPTICS (hand sanitizers)

· Maintaining compliance with in-house and regulatory requirements.

· Reviewing and tracking GMP breaches product recalls and incidents to assess trends and organizational opportunities for training

· Evaluating training programs and materials and designing of GMP training workshops for staffs.

· Facilitating GMP awareness and training for staffs (including non Manufacturing Division staff whose activities have GMP impact).

· Overseeing the design and delivery of programs and ensuring skills of trainers are appropriate.

Integra Life Sciences Corporation

Department of Quality Assurance, Plainsboro, NJ

March 2008 to December 2008

Quality Assurance Specialist

Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair.

Responsibilities:

· Support company goals and objectives, policies, and procedures, and Quality System Regulations (QSR). Represent Quality department in FDA inspections, ISO 13485:2003 and TGA and TUV audits.

· Participate in internal audit program of departments and processes at the Plant.

· Serving as a liaison between QA and other departments and supporting the product complaint program including complaint assessment, trends and identification of complaints related to adverse events inclusive of MDR submissions

· Initiate and handle CAPA, complaints, non-conformances, out of specs and internal/ external audit observations and findings through software’s like InfoMed and TrackWise EQMS.

· Maintain and review Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release. Track Errors in DHRs.

· Initiate Certificates of Compliance and product conformance for Integra LifeSciences OEM partners and customers.

Johnson and Johnson Healthcare Systems

Department of Compliance and Records Management/Piscataway NJ

June 2007 – Nov 2007

Technical Writer (SOX Compliance & Validation)

As part of the internal auditing team in the world’s largest pharmaceutical organization, involved in reviewing internal controls, providing SOX testing and documentation, making recommendations and liaise with external auditors to complete a review of measures in place for compliance.

Responsibilities:

· Preparing and proofreading the existing SOX related documents and coordinate collection of approved documentation.

· Maintaining and reporting SOX testing results.

· Working with each control owner to understand control failures and required process remediation. Track any process remediation list and update management accordingly as required to show the status of process remediation, including items closed out and the addition of new items.

· Identifying exceptions and establish remediation requirements.

· Maintaining Audit logs and updating the existing documentation including Summary Reports and Requirements Traceability Matrix

· Thorough understanding of 21 CFR compliance Part 11 and assisted in creating

Ø Validation Master Plan (VMP)

Ø Standard Operating Procedures (SOPs).

Ø Test plans, Test Scripts and Test cases

Ø Summary reports of IQ PQ and OQ validation protocols

· Tool: Document and Records management system – TRIM Context™

Dendrite Interactive Marketing, Bedminster / Totowa, NJ

Department of Product Development

Jan 2007 - May 2007

Technical Writer

Dendrite IM is headquartered in Bedminster, New Jersey. Spread in over 20 countries, it serves the marketing needs of the world's top 20 pharmaceutical companies.

Responsibilities:

· Recording all the events and updates for the TRIAD project, collaborating with clients and with cross-functional departments including SD, QA and technical support, Product marketing and management to provide continuous improvement to the technical documentation.

· Working closely with Marketing and Engineering to plan, develop, and update new and existing documentation, while analyzing for accuracy and consistency of expression and style.

· Coordinating with project managers from initiation of the TRIAD project.

· Work with all department managers to solicit feedback on product needs and requirements.

· Providing consultative recommendations and proposals to the customer based on knowledge of the customer's business objectives and learning industry practices and trends.

FWA Corporation, Parlin, NJ

June 2006 to December 2006

Business Analyst (Outsourcing)

FWA Corporation serves small businesses and IT firms with training, consulting and web development services to name a few.

Responsibilities:

· Preparing reports, manuals, briefings and presentations, guidelines, and other written materials.

· Serving as liaison between the Project Team and Product Management in order to ensure that all requirements are recorded correctly and updated regularly along the project.

· Co-ordinate meetings and periodically prepared minutes, agendas and status reports.

· Develop BRD, Functional spec, Test Plan and training manuals.

· Monitor the status of iterative Development cycle.

· Facilitated UAT and performed bug tracking and defect reporting in each UAT cycle.

· Worked with service teams to capture operational requirements for the product.

· Conducting periodic status checks with customers and team to assess progress against plan.

Systems Ltd., Karachi, Pakistan

August 2005 to April 2006

Business Analyst

Responsibilities:

· Analyzing the business needs of clients and stakeholders to help identify business problems and propose solutions

· Using RUP framework during the SDLC, support with the Business modeling, high level feasibility, gathering of the requirements, designing and/or reviewing test cases, processing change requests and tracing the requirements during implementation (traceability matrix).

· Re-factory of websites, working with the graphic design and software development departments simultaneously to update storyboard track document changes and update the functional requirements as they change. Supporting the Project Life Cycle from Inception Phase and keeping it within scope and defined timelines up to the Transition Phase.

· Tool: Microsoft Visual Source Safe – VSS

Netpace Systems (Pvt.) Ltd, ISO 9001 Certified

www.netpace.com

May 2004 to June 2005

QA Analyst

Responsibilities:

· Interact with remote team in USA, Technical Interviews, Functional testing, Load testing, Business Cycle testing, Monitor and mange the validation of processes.

· Preparation of installation guides, QA plans and test cases, manage testing lab etc

KalSoft (Pvt) Ltd CMMi Level 3, Karachi, Pakistan

0ctober 2003- May 2004

Test Engineer

Responsibilities:

· Writing of technical documents, Bug life cycle management, Functional testing, documenting various modules of the ERP application and updating its User Guide.

· Verified, constructed and executed white box test cases.

· Successfully handled the Problem Tracking Report (PTRs) and Test logs of various applications.

EDUCATION

B.S Computer Science Mohammad Ali Jinnah University Karachi, Pakistan

CERTIFICATIONS

Quality Systems Certified Compliance Professional (ongoing):

· Root Cause Analysis for CAPA

· Complying with Computers and Software Validation Requirements

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