QA Compliance Senior Specialist

JOB DESCRIPTION:

• developing and implementing the operation of the Quality Management Systems, maintaining the GMP relevant system documents
• reviewing, verifing and approval of GMP documents and ensuring compliance of the QMS with GMP, EU, FDA and local requirements
• ensuring that all actions in quality deviations and complaints are properly conducted and closed (including root cause) in accordance with all relevant regulations and laws
• ensuring, that all corrective and preventive actions are properly defined, planned, distributed and finalized in expected time
• participation in the change control process, making sure that proposed changes are in compliance with GMP regulations and that change control management is in compliance with internal procedures of Polpharma Biologics
• review and approval of suppliers, preparing and reviewing technical/ quality agreements
• ensuring a review of all documentation generated from the production processes including environmental monitoring, cleaning records, equipment parameters/log books, process deviations and microbiology exception reports is performed
• supporting preparation of the unit for pharmaceutical inspections and audits by national and foreign authoritie
• representing the company during regulatory inspections, interacting with regulatory authorities

REQUIREMENTS:

• higher education in biologics, chemistry, pharmacy, biotechnology or related, supported by minimum 5 years of work experience in the pharmaceutical industry,including two years in the evaluation of pharmaceutical products in the area of quality ​​control or quality assurance
• excellent knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceutical drug substance and sterile products
• knowledge of Quality Management Systems, with specific understanding in managing deviations, investigations and corrective/preventing actions
• fluent knowledge of English both, written and spoken

WE OFFER:

• employment contract with opportunity to help shape the success of a leading private pharmaceutical company
• working in a cutting edge biotech laboratory
• great opportunity for professional development and participation in training programs
• competitive salary, performance-related bonus and attractive fringe benefits