Job Type: Perm
Job ID: JO-1908-19267
Consultant: Karen McHugh
Do you have 4+ years’ experience in a GMP analytical laboratory and knowledge of method transfer and validation requirements for products using HPLC?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
Scientific Technical Writer - BioPharma - Waterford
Our client is a leading Contract Research Organization (CRO), working with pharmaceutical, biotechnology and medical device sectors.
The purpose of this job is to serve as a Technical Writer, to work to the highest standards in terms of quality and professionalism.
Preparation of protocols, SOP’s, investigation reports and all other technical documents.
Perform all functions necessary to complete final reports from raw data (i.e. verify raw data, correct, organize, summarize, format) in compliance with ICH Guidelines, applicable SOP's, appropriate report formats.
Write technical summaries for reports based on raw data provided. Complete all other aspects of the report writing as required.
Proofread reports to insure that the data transferred from the raw data is technically and grammatically correct.
Periodically review SOP's pertaining to this job description and recommend changes to these procedures.
Authorise customer work from Analysts once qualified to do so.
Provide cover for other members of staff as required and for taking part in the company’s weekend rota and/or overtime schedule.
Ensure that all documentation is completed on time, accurately and legibly.
Keep their training records up to date and to initiate training where possible.
Update any relevant documentation as required.
Adhere to, and provide a practical lead on, all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
Handle any customer related queries where necessary and liaise with the team to solve these queries if needed.
Ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
Identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.
A degree or diploma in Biopharmaceutical Chemistry/ Pharmaceutical Chemistry or a related discipline is desirable.
At least 4 years’ experience in a GMP analytical laboratory.
Excellent experience of method transfer and validation requirements for products using HPLC.
Thorough technical knowledge of chromatographic instrumentation (e.g. HPLC, CE, ICE), UV/Vis and compendia testing.
Good team player, organised, accurate, have strong documentation skills
Passionate about quality and customer service.
Good communication skills both internally and externally.
Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.
Permanent Full time position
Benefits include medical insurance, pension and life assurance.
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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