Oversee and develop the Quality Management System for Germany:
• Drive and support the harmonization of the company European/Global Quality system together with adoption of parent company QMS systems.
• Oversee the Quality Assurance team and work with other functions on site to drive GMP compliance and improvement.
• Manage the client audit program, planning, hosting, and follow-up.
• Ensure that GMP operations are carried out within the Quality team are completed in accordance with the requirement of the GxP regulations and guidelines, Parent company Quality systems and industry standards.
• Ensure the availability, the update and continuous improvement of the Company EU quality management system.
• Function as Quality department liaison and subject matter expert to other department representatives, customers, and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits.
• Contribute to the quality department's activities to ensure continuity of operations.
• Know, understand, and comply with the company’s standard operation procedures and policies.
• Perform and contribute to qualification of suppliers and vendors of company EU.
• As required, participate in the Quality Management System, including Change Controls, Non-conformances (including root cause investigations) and CAPA.
• To participate in the self-inspection of the Quality System and to carry out independent audits of external vendors as required.
• Support Client hosted audits and Competent Authority inspections of, covering preparation, participation and follow-up/CAPA.
• Train/coach/develop and evaluate direct reports and provide timely and compliant employee counselling as discipline and performance issues arise.
• Identify and support the implementation of improvement opportunities, collaborating with the business areas, to form a strong and effective operational excellence team dynamic.
• Maintain paper and electronic records for quality documentation.
Manage ad-hoc Quality projects.
• Excellent communication and intercultural skills.
• Team worker and team spirit.
• Customer oriented.
• High organisational and planning skills.
• Work with accuracy and reliability.
• Good dose of assertiveness.
Qualified Person acc. to German Drug Law (§ 15) AMG: Release of study drug (Investigational medicinal product) and batch certification
EU import of IMPs, check/evaluation of GMP-compliant batch records
Perform GMP-Audits of IMPs manufacturers in order to prove the IMPs and medication was manufactured in compliance with European rules and legislation (EU-GMP-Guideline)
Direct Support of the EU Director Quality
Monitor permanently the regulatory requirements Company
Support to the compliance of the site’s systems of handling, manufacturing and distribution of Investigational pharmaceutical products
Key Responsibilities QP:
• Maintaining a batch register.
• IMP import: Verify/evaluate import documentation and perform audits to proof that the drug has been manufactured and tested acc. to GMP .
• Prove that the drug has been manufactured, stored, labelled and tested acc. to EU GMP and acc. to the requirements of the German Drug Law.
• Perform GMP audits .
• Contribute to proper coordination of customer audits and inspections from regulatory authorities.
• Perform Vendor / supplier qualification incl. auditing
• Review Batch Packaging Records
• Issue, control and follow-up on complaints, deviations, CAPA, and change control.
• Annual self-inspection of Company Sites: support, conduct, participation and reporting to executive management.
• Maintenance of Site Master File.
• Support validation & qualification activities and processes in accordance with applicable legislation.
• Support management of SOPs & policies.
• Inform team and management on updates on regulatory requirements.
• Contribute that company services are delivered on time and according to the agreed quality standards.
• Take part in the overall improvements of internal processes and systems.
• Perform training of company Staff on GMP/GDP requirements and on the optimal use of the company EU quality management system.
• Cultivate integrated working relationships with employees and other departments to maintain and foster quality standards.
• Support a timely and effective communication and escalation process exists to raise quality issues of Executive committee.
• Contribute to definition to responsibilities for the quality control staff and the controls are performed at the appropriate levels.
• Contribute to establishment and achievement of required quality controls to maintain the quality of products and services provided by company.
• Take part that Quality Control is performed accurately and efficiently in compliance with current legislation. Work with quality controls to guarantee the quality of finished products IMP (e.g. checks on incoming products being conditioned and finished products, specifications, sampling, reference sample).
• Contribute to the Quality Report for the Quality Management Review, where applicable.
• Training of Pharmacist´s applicants’ internship (Germany).
Manage ad-hoc Quality projects .
Qualifications and Experience :
• Experience as Qualified Person and /or in Quality Assurance (5 years).
• Experiences with clinical trials and IMP. Experienced in GMP, GDP, and GCP requirements.
• Experience in management and line management role (minimal 5 years).
Excellent communication and intercultural skills.
Team worker and team spirit.
High organisational and planning skills.
Work with accuracy and reliability.
Good dose of assertiveness.
Qualification as Qualified Person according to German or Belgium drug law
*or, an equivalent combination of education and experience to successfully perform the key
responsibilities of the job
Good in MS Office (MS Excel, Word and PowerPoint)
Fluent in German and English. Any additional language is an asset.