Quality Control Analyst (Pharma)

Develop testing plans for raw materials, in-process and finished products in collaboration with QA.

Perform sampling and QC analysis of raw materials, in-process and finished products using a wide range of methods analytical techniques.

Carry out all work and maintain all data in compliance with good laboratory practices.

Generate CoAs and preform QC batch release.

Perform non-routine analysis as required, including customer/supplier complaint investigations, internal quality deviation investigations, site validation and qualification activity etc.

Carry out calibration of equipment and maintenance of calibration records to the appropriate standard.

Manage stocks of laboratory consumables.

• Prepare lab reagents and standards in accordance with GLP requirements.
• Create and update new SOPs for area of responsibility as required.
• Define and develop protocols in collaboration with QA+RA and carry out stability studies on raw materials and finished products in line with regulatory requirements.
• Collaborate with other departments (i.e. Production, Maintenance, QA, Purchasing) on the design and implementation of site qualification, validation and verification plans.
• Participation in site meetings as required on QC topics.
• Carry out bench scale trials for new product formulations in collaboration with QA, VAS, RA and Commercial teams.

Požadujeme

• 3rd level education in chemistry or related subject
• Fluent in Czech, fluent in English
• 2+ years previous practical laboratory experience in pharmaceutical laboratory or related field.
• Experienced in wet chemistry.
• Experienced in the use of analytical techniques such as HPLC, GC, UV-Vis, FT-IR.
• Knowledge of GMP or GLP.
• Knowledge of APIs, Excipients & Biopharma raw materials.
• Experience in completing analysis using European. Pharmacopoeia test methods.
• Experience in method development and method validation.
• Good communication skills.
• Experience in other aspects of lab management including managing consumables, deviation investigations.
• Ability to work independently under own initiative.

Nabízíme

Working for a large multinational, in your new role you will work in the Quality Control function at a modern state of the art Excipient and Pharmaceutical Raw Material manufacturing site. 

Joining a new site in the setup phase, you will have the opportunity to set up the lab and contribute within the Quality team to establishing a new Quality strategy for the site.