As a Quality Assurance Compliance Expert you will be responsible for design, effective implementation, monitoring and maintenance of Quality Management System (including related electronic systems). Ensuring that all operations related to the quality system are carried out in accordance with applicable regulations and procedures. Coordination and implementation of quality projects. 

Your responsibilities include, but are not limited to:

• Continuous improvement of knowledge in the field of performed tasks through participation in training and following professional literature.
• Assessment of Facility readiness for any Inspection and audits.
• Participation in supporting QMS in internal / external audit processes and Inspections.
• Issuing an opinion on corrective and preventive actions in the field of GMP, Pharmaceutical Law, EMA, PIC/S, WHO, ISPE, PDA, EU GMP, FDA as well as regulatory provisions and registration dossier.
• Verifies the scope of effective CAPAs, (post-audits and post Inspections).
• Participation in giving opinions and implementing the change control process within the scope of her specialist knowledge.
• Supporting building a Quality Culture in the organization.
• Participation in the supplier qualification process including Notifications from suppliers/service providers and to contract givers. Quality Agreements, External Audits, Supplier Complaints.
• Participates in the verification of the compliance of the quality documentation of products intended for clinical trials, manufactured active substances, transfer, process and validation documentation with regard to the registration dossier, the scope of obtained manufacturing  and marketing authorizations.
• Taking part in the risk assessment process.
• Participation in the supplier qualification process including Notifications from suppliers/service providers and to contract givers. Quality Agreements, External Audits, Supplier Complaints.
• Management of documentation and archival process.
• Deputy of Quality Compliance and Management review Manager in case of absence.
• Working in computer systems, e.g. TrackWise, SAP, LIMS.
• Ensures confidentiality of matters covered by professional secrecy, protection of personal data and other data in the subordinate area.
• Participation in internal and external audits and inspections.

If you have:

• Over 5 years of experience in the (bio-)pharmaceutical industry with special focus on manufacturing.
• Higher degree in pharmacy, biotechnology, or other related field.
• Very good knowledge of Pharmaceutical Law, GMP requirements and regulations regarding pharmaceutical products, investigational products and active substances.
• Knowledge of manufacturing and analytical technologies related to the assessment of investigational pharmaceutical products and active substances.
• Strong knowledge of quality management system.
• Organizational skills and the ability to work under pressure.
• Decisiveness.
• Very good working knowledge of English language (written and spoken). 
• Ability to represent the company in external contacts.

What we offer:

• Competitive salary.
• Private healthcare.
• Life insurance.
• Pension plan above national standards.
• Additional free day.
• and more..