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reference: 4861245

documentId: 4861245

connectionPointId: 7

lastModificationDate: 1533627563913

stillingsbetegnelse: Quality Assurance Scientist for QA Operations

jobbeskrivelse:

Join a dynamic and international company where everyone is responsible for delivering right on time as one team!

The QA Operations team is looking for an experienced QA scientist to assist with quality assurance of manufacturing activities and batch release of a biological API for phase III clinical trials and Process Performance Qualification (PPQ) for commercial approval in the US and EU. 

QA Operations
Team QA Operations consists of highly qualified technicians and scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the Operations team, the quality unit department consist of the teams Quality Systems and QA Facility and Equipment. The main responsibility of the Operations team is quality assurance of manufacturing activities, batch release and QC documentation. We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that manufacturing and QC activities are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines. The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high service level to our colleagues in the rest of AGC - and not least to our international customers. The Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

Tasks and Responsibilities
As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. QC documentation, Batch Production Records, Master Production Records, specifications, analytical procedures, stability documentation, validation processes (manufacturing process and analytical method validations), change requests, deviations and CAPAs. You will contribute to the handling of mentioned team tasks, and a major part of the job will be on activities related to preparation for Process Performance Qualification (PPQ), production documentation and Quality Assurance guidance of manufacturing staff. Also you will be handling customer contact on quality related activities and participate in external and internal audits. You will be point of contact for customer quality organization.

I your daily work you will be the lead of for the release process in the projects you are QA responsible for. We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP. A part of the job consist of class room training and “one to one” training of relevant departments. 

Your Profile
Preferably you have experience with Quality Assurance of API manufacturing. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology or similar. Ideally you have experience with a number of the following areas:
• Review and evaluation of Master and Batch Production Records.
• Deviation handling and performance of root cause investigations. 
• QA oversight of manufacturing activities and guidance of manufacturing staff.
• Professional presentation of quality in customer relations.
• Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks.
• Quality assurance of manufacturing process validation (PPQ). 

It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent. 

AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. For further information regarding the position, please do not hesitate to contact Director QA Facilities, Lise Marie Christensen, telephone +45 2294 3058, or QP Manager Hanne Jørgensen, hjorgensen (at) agcbio.com. We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than August 25th, 2018. Qualified applicants can expect to be called for interview before the deadline.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0:
Send ansøgning på en af de angivne kommunikationskanaler

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: CMC BIOLOGICS A/S

source: DK-STAR