· Excellent documentation skills GDP
· Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. Close contact maintained with Quality Assurance Production, Engineering and Planners.
· Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeia and regulatory requirements.
· Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP’s and updates.
· Trend such results, record on COA’s where required and complete OOS’s investigations on a timely basis.
· Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
· Ensure all quality documentation and records are complete and current
· Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
· Ensure relevant procedures are correctly defined and followed
· Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
· Audit and review chemistry test results daily and ensure compliance with cGLP.
· Checking/auditing laboratory notebooks and analytical reports
· Always ensure compliance to cGMP
Job Type: Full-time
Pay: €35,000.00-€50,000.00 per year
Schedule:
- Monday to Friday
Application question(s):
- would you have any of this - UV, KF, HIAC, SDS Page, HPLC experience at all?
Experience:
- pharmaceutical: 1 year (required)
Work Location: In person
