Contract: 1 year
Working Hours: Mon – Fri 8.30am-6pm
- Project Management: Analytical, Raw Material and Microbiological Method Introduction
- Project Management: Analytical Equipment Qualification
- Regulatory Filing and Method launches
- Invalid results tracking, trending and investigation
- Unexpected results investigation
- Control Trend establishment and investigations
- Reference Standard and Reagent qualifications
- Compendia review
- Continuous Improvement
- Audit Preparation and Involvement and other tasks as assigned.
- Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
- A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
- Basic assay verification/validation know-how
- Team player and independent contributor
- DMAIC tools experience
- Presentation skills for audits and validation teams
- Experience in problem solving (facilitation and application of tools)
- Basic statistical knowledge and experience with data analysis
- Knowledge concerning cGMP, especially lab related topics as method validation life cycle, uunexpected results, critical reagent qualification
- Basic knowledge about regulatory requirements concerning analytical test methods and licenses
- Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
- Knowledge in Microsoft Office
- Project Management Skills
- Communication and organizational skills
- Strategically and Business oriented thinking
- Good verbal and written communication skills
Interested candidates, do submit your resume in Word document to: email@example.com
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820