GBS H&N Pharma - R&D Technical writer (Level II)
GBS H&N Pharma - R&D Technical writer (Level II)
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Job Description
Primary Responsibilities:
As a member of the team in our Global Business Solutions (GBS) center the Technical Writer will be responsible
for writing methods protocols reports SOPs and evaluating compendia procedures as it impacts the pharmaceutical products or raw materials.
Additionally responsible for supporting the scientists in R&D to prepare the documentation as required by clients including follow up of change controls maintaining the templates for laboratory documents.
In addition responsible for periodic review of the compendia changes and providing evaluation as it impacts the Raw Material Finished Product and R&D groups within Analytical Operations.
Specific Responsibilities:
- Write or review protocols for method development feasibility transfer verification and validation projects in collaboration with R&D personnel. Write or review client methods for routine sample analysis as needed.
- Collect and provide the necessary documentation for R&D projects such as sample specifications method details and validation reports. Ensure the testing instructions are timely available and unambiguous to facilitate the bench work complete as scheduled.
- Document analytical findings by compiling data into standardized report templates.
- Review the compendia updates (e.g. USP EP JP) document changes and communicate updates to relevant departments. Act as a technical resource for team members providing guidance on documentation issues.
- Track the progress of R&D projects to ensure completion including document organization. Inform the appropriate manager if assigned work cannot be completed within the expected timeframe and quality standards.
- At all times comply with SGS Code of Integrity and Professional Conduct and with all SGS QHSE and HR policies and procedures. Ensure the work area in GBS is always clean and presentable.
Qualifications :
Profile:
- Bachelors degree in chemistry or a related science field with 35year experience or masters degree in chemistry or a related science field with minimum 2 years of experience in pharma laboratory setting preferably in R&D.
- Good understanding of analytical methods the ability to break down complex procedures into detailed steps and familiarity with planning and documenting new method development.
- Demonstrated understanding of cGMP regulations. Knowledgeable in all regulatory guides impacting their specialized field such as ICH FDA TPP pharmacopeias.
Required Skills:
- Excellent command of the English language (C1 as minimum) with strong verbal and written communication skills (grammar and composition).
- Proficiency in Microsoft Office Suite (Word Excel PowerPoint and Outlook).
- Proven ability to manage and coordinate multiple projects in a fastpaced professional environment.
- Strong interpersonal skills and the ability to work both collaboratively and independently.
- Proven time management skills and meticulous attention to detail.
Informacin adicional :
Horario: Lunes a viernes presencial
Salario Bsico: $6.000.000
Modalidad de contrato inicialmente obra labor despus de 6 meses y segn desempeo pasa a contrato con termino indefinido.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
