CV Advice please

[bhurinder]

Career Summary
I graduated from university with a BSc Chemistry and have a background in the Pharmaceutical industry.I have a strong understanding of current US and European regulatory requirements particularly associated with computerised system validation in the pharmaceutical industry (FDA 21 CFR Part 11 AND GAMP 4 & 5 guides).
My involvement within Validation has seen me:
o Providing support and regulatory guidance to the GSK Maidenhead site by assessing the quality critical aspects of each computer system.
o Using project management tools to manage the validation requirements by liaising with the key customers ensuring that FDA and MHRA requirements are met.
o Compose validation documentation i.e. project plans through to final reports as required to bring systems up to regulatory standard utilising GSK corporate standards.
o Provide metrics on a monthly basis to track and monitor the progress of the validation project.
o Review current business systems and computer system processes for compliance.
o Write and review SOP’s.
o Ensure the change control system is in use and correctly applied.
o To ensure that GMP, quality, health & safety are considered in all aspects of role.
o Involved and experienced GSK corporate audits and MHRA audits.
I have also been Involved in MIA (Internal GSK) & MHRA audits as part of the control team I was trained in a technical role to use the Dream system which helped support the site during the inspection.
I feel that with my good interpersonal skills, I am capable of working with people from a wide range of disciplines and I am confident in asserting compliance decisions.
Career History
GlaxoSmithKline, Maidenhead. Oct 2004 – Present
Computer Systems Validation Engineer
This position, in the Validation Team, involves the documenting, approving, and execution of validation activities for computerised systems in compliance with company policies and all applicable international standards and directives applicable to GMP and GLP industry and to maintain compliance with all EC directives and statutes relating to the UK law. I combine this position with the added responsibility of being the Site administrator for LIMS at Maidehead.
Projects that I have worked on are:
Process Control Systems
o Retrospective Software Validation of Process Control systems on Filling and Packing Lines for licensed & cosmetic products.
o Software Validation of mixing manufacturing suites for licensed & cosmetic products.
IT Systems
o Software Validation of a web based system- Automatic Bulk Batch Document Issuance System.
o Software Validation of Laboratory Information Management System (LIMS).
Lab Systems
o Software Validation of Chromatography Data Systems.
o Validation of Spreadsheets & Databases.
LIMS
I combine this role by having the added responsibility of being the Site LIMS System Administrator, I have administrator access to LIMS which enables me to:
o Configure LIMS.
o Purging of raw & bulk samples.
o Adding, modifying & approving specifications.
o Adding, modifying & approving tests & calculations.
o Updating of sample information on LIMS.
o Training of new & current LIMS users.
o Creation and modification of LIMS user accounts.
o Writing and reviewing SOP’s.
o Use of the Cals account to reboot the server BREU01 for LIMS.
o Daily system checks.
o RGEN event protocols.
GlaxoSmithKline, Maidenhead. Aug 2003 – Oct 2004
Secondment to LIMS
o This position involved assisting the Quality IT systems owner lead the development and maintenance of lab quality IT systems in line with site, GSK and external regulatory requirements. Work involved supporting the chemistry and micro labs in the form of adding, modifying, validating tests and calculations on LIMS. Adding, modifying, approving and validating specifications. The role also involved change control, purge, kill test, change status functions within LIMS and adhoc report retrieval.
GlaxoSmithKline, Maidenhead. Dec 2001- Aug 2003
Raw Material Analyst
o My job purpose was to participate in the routine work of the analytical lab to ensure the acceptable quality of raw materials. Duties involved were to take samples of bulk tanker deliveries, factory waters and testing raw materials using analytical methods. I am fully trained on operating instruments such as HPLC, GC, FTIR, Karl Fischer titrator, Brookfield viscometer and maintaining and calibrating these instruments by following proper housekeeping and operating procedures. I am also familiar with investigating quality-related issues using OOS (Out Of Specification) procedures.
Amersham International, Little Chalfont, Bucks. Jun 2001-Sept 2001
Raw Material Analyst
o This position involved routine analytical work using various techniques such as FTIR, pH readings, titration’s, Gas chromatography. This insight into a big organisation gave me a good understanding of how to follow good control laboratory practices (GcLP) at all times. I was able to share responsibility of maintaining the working environment to an acceptable standard and work as an effective team member.
Professional Courses
Commissioning & Qualification Document System – GSK April 2008
Certified OE Advocate – GSK June 2007
GMP Training – GSK Nov 2007
Quality Leadership Training – GSK Mar 2006
Intranet Community Training – GSK July 2005
Supplier Assessment for GSK Computer Systems – GSK Jun 2005
GSK Fundamentals of CSV – GSK Oct 2004
Supplier Assessment for GSK Computer Systems – GSK Oct 2004
Using Regulated Electronic Records and Signatures at GSK – GSK Oct 2004
Requirements Phase for GSK Computer Systems – GSK Oct 2004
Computer System Testing and Qualification – GSK Oct 2004
Computer System Inspection Readiness – GSK Oct 2004
Effective Presentation Skills – GSK Oct 2004
Introducing Neuro Linguistic Programming – Dec 2003
Fundamentals of Successful Project Management - Skillpath Seminars, Oct 2003
Basic Auditing – GSK Maidenhead, April 2003
Operational Excellence Training – GSK Maidenhead, Feb 2003
IT Skills
Systems Used
o LIMS (LABC21 – Beckman Coulter CALS - Now InnaPhase).
o BPCS.
o ABBDI.
o Microsoft Word, Excel, Project, Visio, Powerpoint.
o Microsoft Windows NT, 2000, XP.
Education
BSc Chemistry – University of Hertfordshire.
Science Foundation Course – Oaklands College, St Albans.
GCSE’s 8 grades A-C inc: Maths, English and Science – Altwood Secondary, Maidenhead.
References
Available on request

[cvsage]

Very good intentions and correct information but spoilt by poor layout and use of the first person "I". Take that out, completely. It's only acceptable for young kids.

[David at BrilliantCV.Com]

You seem to have plenty of good qualifications and career experience that would be valuable to a potential employer. As CV Sage says, you have all the right information.

However, what I would say is that you don't have it in a layout that is clear and easy to understand.

My own suggestion would be to lay your CV out as follows:

At the top of your CV state your name, address, telephone number and email.

Next, create a list of three to five bullet pointed sentences which state the key skills, experience and qualifications that prospective employers in your field are looking for. You should be able to identify what a prospective employer is looking for from the advertisement or job description they provide. The idea of this is to give a quick snapshot of what you have to offer that will persuade a recruiter to retain your cv for further consideration rather than file it in the bin.

Next, give more details of your relevant skills and experience. To do this, identify the core areas of responsibility you have held over the last five years which are relevant to the particular role you are applying for, and write three focused sentences on each area.

Next, state your career history over the last ten years, starting with your most recent role and then working backwards.

Next, write a section which covers your education history.

Finally, state any current or recent (within the last two years) training you have had which is relevant to the role.

If you break down the information you have provided in your post and lay it out in the way I have suggested you should be able to create a presentable and effective CV.