Quality Control Analyst
- Contract Type
Quality Control Analyst - Italy
Scope of work:
- Performing analysis on raw material, In-process tests, intermediates and API in line with cGMP.
- Conduct other analysis as required including samples relating to investigations, development and stability.
- Ensure QC team work in a safe manner
- Adhere to good laboratory practices and housekeeping standards (ICH, CFR, Pharmacopoeia and client guidelines).
- Write and review laboratory TMs, SOPs and QC documents as required.
- Ensure that testing and results approvals are completed within agreed turnaround times.
- Maintain and develop knowledge of analytical technology as well as cGMP standards
Education & Qualification Requirements:
- Fluent in Italian and English ideally
- Degree in Analytical Chemistry, Chemistry or related discipline.
- Have a relevant experience in a pharmaceutical/healthcare laboratory.
- Proven experience with analytical separation techniques including HPLC and GC.
- Operational experience of Empower, SQL LIMS, and other lab IT application systems would be an advantage
- Be proficient in the use of Microsoft Word, Excel. Have strong report writing skills.
- Strong communication and interpersonal skills.
- Be details oriented, self-motivated with good trouble shooting and problem solving abilities.
Analyst(s) must be able to perform:
- Chromatographic tests (HPLC /UPLC / TLC/ GC/ GC HSS) with the software Empower II
- Able to operate with highly potent substances handled in isolators (glove box)
- Must have recent bench experience
Systems: Empower, Trackwise and Smart Team.
Languages: Italian preferred. Would consider English speakers with relevant skills