Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by FDA, EMEA, ICH, and PIC/s. To assure compliance, quality and manufacturing systems are defined, implemented, practiced, maintained and matured. The Quality Affairs Department is responsible for development, implementation, updating, auditing of and reporting on the status of the Quality Systems of Patheon Groningen, Quality Assurance, Quality Control tasks in relation to the manufacturing operations and batch disposition decisions.
Single person accountable for undertaking the QP responsibilities and duties and for technical contribution to the operations at Patheon Biologic Groningen as listed in key responsibilities
Job and Position Context
The Groningen site is a multiproduct and multi-client site that provides full spectrum biopharmaceutical manufacturing services (i.e. development, clinical trials, process performance qualification and commercial manufacturing) in the production of bulk Active Pharmaceutical Ingredient (API)/Bulk Drug Substance (BDS) via mammalian cell culture. This facility complies with all rules and regulations of current Good Manufacturing Practice (cGMP) set by individual jurisdiction health and welfare ministries.
Job ContentKey Areas of accountability/responsibility
Execute Qualified Person (QP) responsibilities, duties, batch certification and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16. If the product is to be released to the US market, all appropriate cGMP's requirements as defined is US. “CFRs” and other relevant regulations should be complied with.
Ensure that products are manufactured in accordance with GMP, site procedures and applicable regulatory requirements.
Maintain a thorough and up to date understanding of international regulatory guidance, corporate and client requirements pertinent to the site, and to ensure that all work within the site complies with these and with site procedures.
Take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting any QP batch certification and disposition.
Undertake regular audits, self-inspections and spot checks.
Undertake and support investigations, root cause analysis and review & approve Major/Critical deviation, Complaints and any change proposals with process/product impact.
Undertake and support the QMR process.
Undertake and support the implementation of Operation Excellence by encouraging peers and stakeholders to identify, lead and implement improvements.
Act as change agents by gaining support for and driving sustainable improvements to ways of work
Proactively ensure continuous improvement of the QMS and that it is inspection ready and maintained in a state of control
Proactively drive and react to system trending (e.g. deviations, complaints and environmental management) to ensure ongoing quality performance and improvements.
Establish and maintain effective communication with clients to match internal and external client expectations
Interact with national and international Ministry of Health authorities and regulatory inspections.
Complexity of the Job
The Patheon Biologics site in Groningen manufactures many products for several stages of clinical trials and for commercial use. The cGMP systems in use on the site must reflect the dynamic, constant changing, regulatory environment for biopharmaceutical products.
Knowledge and educational level
Minimum Degree in Chemistry, Pharmacy or Microbiology
Experience acting as a ‘Qualified Person’ as defined in 2001/83/EC and 2001/82/EC (as amended)
Required Level of Experiences
Substantial experience working in a pharmaceutical quality function, preferably within a biological manufacturing site.
Up to date knowledge of the principles and guidelines for GMP as set out in: EU “Eudralex Volume 4”, U.S. “CFRs” and other relevant regulations.
Excellent scientific and technical knowledge
Pre-requisite for this job is that the candidate is not on the “FDA DEBARMENT LIST”
Capable of working to deadlines and prioritize multiple tasks
Excellent written and verbal communication skills to internal and external stakeholders
Flexibility to meet changing needs and priorities of the business
Pragmatic, well organized with logical and methodical approach to work
Leadership experience and the have the strength of character to guide cross-functional teams of professionals