Qualified Person for Pharmaceutical Drug Product and Drug Substances.
NerPharMa Srl (part of NMS group), a leading Contract Development and Manufacturing Organization (CDMO), is pleased to announce the expanding of Quality Unit Team, in order to ensure the highest standards of quality, safety and compliance across NerPharMa’s extensive range of services, offered through both Drug Substances and Drug Product divisions.
The NerPharMa site produces both commercial and clinical products, with a robust and flexible pipeline, also counting on the support of R&D Department team present in the site. In details, NerPharMa produces oral, sterile and injectables forms as finished products in Drug Product department and produces highly potent compound (API) in a Drug Substance department. Most of productions are focused on drugs for oncology for clinical and commercial use.
The current research is focused on a Quality Assurance – Qualified Person for Pharmaceutical Drug Product and Drug Substances.
The position will be part of Quality Team (0rganized in Quality Control, Quality Assurance, Quality System and Regulatory teams, with about 50 employees), reporting to site Quality Unit Director.
Main responsibilities:
The Qualified Person is responsible to ensure that licensed product is produced and certified in compliance, following EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16 and AIFA regulations.
- Manage the batch disposition process to ensure timely release of product
- Ensure the batch disposition process maintains compliance with site practices & regulatory requirements
- Support major investigations, ensuring all product deviations are closed prior to batch release
- Participate in cross functional teams as Quality/Qualified Person representative
- Provide additional QP support to quality related issues, as the need arises
- Participate on internal committees/teams, as required
- Provide advice and direction to other departments on quality issues
- Reporting to Quality Unit site Director ensure independence of the QP on decisions on quality related matters
- Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements
- Provide audit support as required for internal auditing program and supplier audits
Requirements for the position
- Certification as Qualified Person by AIFA – Italian Health Authority (Certificazione come QP da parte di AIFA in accordo al Decreto Legislativo 24 Aprile 2006 n. 219 ed a tutti i requisiti necessari secondo AIFA)
- Post Graduate Qualification required (MSc or equivalent)
- Ideally 8+ years of cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer’s/Importer’s Authorization (MIA) ; consideration will be given to other relevant experience and education
- Experience in managing Health Authority audits, CAPA plan and its related documentation
- Pharmaceutical manufacturing experience in Sterile and API manufacturing highly desirable
- Proven leadership skills comparable to 2+ years of management responsibility
- Problem solving, risk assessment and impact analysis abilities
- Training/mentoring experience
- Italian and English fluent languages
About NerPharMa
NerPharMa owns a wide and cutting-edge organizational structure able to manage and handle highly active compounds, and to ensure the full development and production of active principles and finished products intended for the world market as well as the research and development of innovative formulation and delivery systems. The two divisions in NerPharMa, NerPharMa DS (drug substance) and NerPharMa DP (drug product), operate in accordance with Current Good Manufacturing Practices (cGMP) and are authorized by the most relevant authorities: Italian Drug Agency (AIFA), U.S. Food and Drug Administration (FDA), ANVISA Brazil, China FDA, PMDA Japan and Russia for the production of both pharmaceutical active ingredients and finished products.
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