Quality Assurance Specialist

For our client, a leading chemistry company that provides a range of services to support small-molecule drug discovery and development projects for biopharmaceutical companies in the USA, Europe, and Japan, we are looking for a suitable candidate for a position of Quality Assurance Specialist.

Position description

• The Quality Assurance Specialist manages the QA aspects of the production of small-molecule APIs for clinical trials or for commercial use
• They write, review, approve, and archive documentation for the production and analysis of the products, equipment, facility, and personnel in close collaboration with the Head of QA, Head of QC, and Head of Production
• The activities include the release of raw materials, intermediates, and products produced under GMP
• The Quality Assurance Specialist will be involved in the investigation of deviations during production, out-of-specification observations, change control procedures, risk analysis, and CAPA management
• They will be part of the continuous improvement of our Quality Management Systems, involved in Quality Audits and the qualification and auditing of subcontracting laboratories and service providers

Key requirements

• University education in analytical chemistry, organic chemistry, or a related discipline
• At least 5 years’ experience in the pharmaceutical industry in a related position; experience in early development of small molecules is an advantage
• Strong knowledgebase of GMP requirements for small-molecule APIs ; experience with investigational products (ICH Q7, chapter 19) is a preference
• Experience in the qualification and validation of facilities, equipment, methods, and processes
• Technically minded, able to solve problems at the interface of QA and science and technology
• Knowledge of IT/CSV and related QA requirements
• Good command of the English and Czech languages
• Advanced user of a personal computer (Word, Excel, Outlook, technical software)
• Good communicative and organizational skills, a team player
• Reliable, accurate, and accountable personality

We offer

• An exciting position in a dynamic organization with an attractive remuneration package and opportunities for learning and development
• 45 000 - 50 000 CZK, the salary will depend on the candidate´s skills and experience and it may be a subject of further negotiations
• 5 weeks of holiday
• Flexible working hours
• Possibility of partly working from home, if the type of work allows it
• Contribution to pension and life insurance
• Contributions to life events (wedding, birth of a child, life anniversary)
• Refreshment at the workplace for free
• Meal vouchers
• Location of the workplace: Běchovice

If you are interested in this offer, please send us your structured CV. We will contact you as soon as possible.

Candidates, who are not suitable for the position, will not be contacted by PŘEDVÝBĚR.CZ.

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