Operational Quality Assurance Coordinator (Downstream Processes)

In this position you will be tasked with improvement of the pharmaceutical quality system in accordance with applicable provisions and guidelines. You will be able to plan and participate in qualifications and validations of process equipment, automated instruments, laboratory equipment and other systems. You will be responsible for preparation and reviews of quality documents, recommendation of corrective and preventive actions and control of their results.

• Ongoing compliance with quality and industry regulatory requirements
• Supervision of the manufacturing activities – procedure adherence, records revision, cleanroom conducts, aseptic technique
• Participation in the batch record creation and records verification
• QA and production personnel coaching
• Participation in the implementation of the Company's projects
• Implementation of quality process improvements
• Monitoring of key quality indicators in operational QA Team
• SME assessment of production and QA procedures
• Participation in audits and inspections as well as implementation of post-audit recommendations
• Impact assessment of the planned changes, execution of activities resulting from change control process
• Active participation in the development, revision and approval of system documents
• Writing and reviewing the Quality Assurance Documentation (procedures and instructions)
• Coordination of training activities and overview of documentation in Quality Assurance Department
• Gathering the data and reporting of results for key quality performance indicators
• Timely completing other tasks and projects commissioned by QA Manager

• University degree (preferably: biotechnology, microbiology, chemistry pharmacy or related) or documented effective experience in a similar position in a pharmaceutical company
• Ability to organize work and make decisions under time pressure
• Knowledge of biotechnological manufacturing technologies of pharmaceutical products and active ingredients
• Knowledge of Downstream Processes is highly desirable
• Knowledge of the principles of GMP, Pharmaceutical Law, EMA, PIC/S, WHO, ISPE, PDA, EU GMP Annex 1, Annex 15, Annex 16
• Knowledge of qualification and validation processes
• Communication and interpersonal skills, teamwork skills, ability to effectively transfer knowledge in the training process
• English level allowing effective communication in written and verbal format as well as writing reports using formal and scientific English terminology
• Ability to solve problems and perform complex tasks
• Analytical skills in the field of trend analysis, statistical data processing
• Ability to work with MS Office