Quality assurance manager

promoting quality achievement and performance improvement throughout the organisation; maintaining awareness of the business context and company profitability, including budgetary control issues;

I am an enthusiastic capable individual with over four years experience in pharmaceutical testing and manufacturing environment & health related products Quality Assurance,& also including 2+ years biologist & Reseach medical officer. This experience has been gained under both EU and USA GMP regulations and has involved preparation of batch records for review by Qualified Persons and senior QA management.

My ambition is to become a Qualified Person, and I am looking for a role that will provide me with the necessary experience to help me work towards my goal.

Key Skills

QA systems experience
Trackwise experience
Chemical expertise as an analyst and as member of Royal Society of Chemistry
Quality systems auditing skills
Product Quality Review expertise (10 products per year)

Most Recent Employment
oct:2002-house officer

jan 2003- Date: Quality Assurance Officer - Bio Products Laboratory
(Sterile/Aseptic Manufacturing)

Review of Batch Processing records for Marketed and Clinical Trial Products to
ensure compliance with GMP and product registrations in readiness for QP release.
Ensuring prompt handling and review of quality incidents and documented records.
Working in close co-operation with production personnel to resolve product quality and documentation problems and related issues.
Routine analysis of pharmaceutical products for the Inspection and Enforcement division of zmu.

Professional Training:
pharmaceutical Microbiology
Batch Record Review and Product Release Procedures (ZMU Associates)
Pharmaceutical GMP Fast Track (Pharma Systems International (UK) Ltd)
Root Cause Analysis (Quality Management & Training Limited)
Audit Training (BPL Internal Training)
Regulatory Affairs Induction (BPL Internal Training)
Research & Health medical officer:Civil hospital klarachi pakistan.

Relevant Knowledge:
Key EU Directives
ICH Guidelines.
Professional Affiliations :
Member of the Pakistan Medical & Dental Association Pakistan.(PMDC)
Member of the Pharmaceutical Quality Group - Institute of Quality Assurance.

IT Skills:
Trackwise user skills
Use of Microsoft Word, Excel and Internet.

Education and Qualifications

1996 - 2001: M.B.B.S- Includind Pharmaceutical and Chemical Sciences,& health study University of sindh jamshoro.
1995 - A-levels - Chemistry, Biology. AS levels - Maths, Physics
1990- 1992: GCSEs - Nine with Maths, English and Science

M.B.B.S Degerr certificate
Pharmaceutical Microbiology.
house JOB certificat.
Quality Control Analyst - zmu certificate.
analysis of pharmaceutical certification.

Quality assurance (QA) aims to ensure that the product or service an organisation provides is fit for its purpose and meets customer expectations. A quality assurance manager co-ordinates the activities required to meet this aim.

The QA manager monitors and advises on how the quality management system is performing and publishes data and reports regarding company performance against set indicators.

Since maintaining quality demands constant change to meet customer expectations, quality assurance (QA) managers employ a variety of measures to place quality at the heart of an organisation. These include management systems such as ISO 9000, philosophies, such as Total Quality Management, and methodologies such as Continuous Improvement.

The work of the QA manager varies with the organisation but is likely to include some or all of the following activities:

Quality assurance managers liaise with managers and staff throughout the organisation to ensure that the QA system is functioning properly. Where appropriate, the QA manager advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality.