Head (M/F/div.) of Quality Assurance - Operations
Vor 2 Tagen
What we offer
You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.
Click on the link to learn more about Evonik from our employees:
RESPONSIBILITIES- Management of the Quality Assurance - Operations Unit at the Hanau Site of the Business Line Health Care. In this capacity his department ensures Quality Assurance support and oversight of all routine operational activities (manufacturing, quality control, warehousing and distribution) at the site- Contribution to the establishment, maintenance and continuous advancement of an independent Quality Unit and to the design, implementation and continuous improvement of a respective Quality Management System at the Hanau site- Ensuring the permanent compliance of the department, its facilities, computerized systems, equipment and procedures with the national and international laws (e.g. AMG, AMWHV, 21CFR part 11), regulations (e.g. DIN EN ISO 9001, ICH Q7 and EU-GMP-Part II including applicable Annexes, other relevant ICH-Guidelines and guidelines issued by international regulatory agencies such as US-FDA, EMA, etc.) and pharmacopeial requirements (e.g. current editions of the Ph. Eur., USP, JP, etc.) for the standard products manufactured at the site.- The incumbent ensures, in consultation with the Head of Quality Management and the Head of Quality Assurance - Materials & Compliance, that requirements are translated into local procedures, are implemented consistently throughout the organization and are kept current as requirements evolve- Ensuring the timely and (if applicable) GMP-compliant batch record review for all products and timely and GMP-compliant batch disposition of all products routinely manufactured at the site - GMP-intermediates and final products, in particular active pharmaceutical ingredients (APIs) and pharmaceutical excipients - in compliance with all relevant quality-related legal and contractual obligations, and in compliance with customer and internal Evonik-requirements- Assuring adequate and GMP-compliant investigation and approval of all out-of-specification (OOS-) results, deviations and implementation of relevant CAPAs and change controls before disposition of affected product batches has been performed by the respective responsible department- Ensuring timely compilation, review and approval of Product Quality Reviews/Annual Product Reviews for the standard product portfolio of the site- Representation of the department in cross-functional or global Business Line projects- Assuring timely negotiation, update and implementation of Quality Agreements with customers for the site’s standard product portfolio covering all necessary overall and site-specific topics- Responsibility for the effective administration, management, departmental staffing, execution and support of national and international regulatory and supervisory agency inspections and customer and internal audits and for the timely implementation of CAPAs and areas for improvement as regards the standard product portfolio of the site- Assumption of full ESHQ-responsibility for the organizational unit NC-HC-EQR-QIA-QMW-QAO
REQUIREMENTS- Successfully completed degree in natural sciences (chemistry, physics, food chemistry, pharmaceutical sciences) or engineering; PhD strongly preferred- Several years of experience in the pharmaceutical or fine chemicals industry, preferably in a GMP-environment- Experience in leading quality assurance sub-units is strongly preferred- Excellent knowledge of national and international pharmaceutical legislation (AMG, AMWHV, 21 CFR 11), regulations/guidelines (EU-GMP-Guide, ICH-Guidelines) and pharmacopeial requirements (e.g. Ph. Eur., USP and JP)- Good knowledge of DIN EN ISO 9001 and 14001- Ability to lead interdisciplinary teams- Excellent command of English and German language (verbal and in writing)- Good line management as well as negotiation skills- Excellent communication skills and ability to work in a team environment- Willingness to travel nationally and internationally (approx. 10 %)
Your Application-
Company is
Evonik Operations GmbH
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