QA Document Control Specialist

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To our fast growing site in Denmark we are looking for a QA Document Control Specialist who supports the GMP production site in Risskov/Lystrup, Denmark to ensure Quality Management System, Customer, and Regulatory Requirements are met. This role is responsible for administrative and project based tasks within the Quality Assurance department. The role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. You are primarily responsible for the Batch Record Review and Document Control processes.

Areas of Responsibility: 

  • Review of batch production records for completeness and release
  • Review of analytical records and any supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures.
  • Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations.
  • Perform routine document control activities including creation and/or revision, processing, routing and review.
  • Assists in performing QC data review for batch record in-process and final QC approval.
  • Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance.
  • May be called upon to assist with the Supplier Qualification program.
  • Perform additional tasks, as assigned

Education/Experience: 

  • Preferably you are a trained Lab Technician (laborant/laboratorietekniker) or a professional from the health care system with administrative flair.
  • Working knowledge of quality systems and ability to apply GMPs in accordance with standards.
  • Familiarity with ISO 9001:2015, ISO 13485:2016 and 21 CFR 820.
  • Industry experience in managing document control processes and software.

Personality:

  • Quality conscious with strong attention to detail
  • Self-motivating personality
  • Excellent people skills
  • Able to successfully multi-task and prioritize in a fast paced environment
  • Good collaboration and communication skills
  • Positive attitude and a sense of humor.

About us

LGC Biosearch Technologies in Risskov is producing custom-made synthetic DNA and RNA oligonucleotides to support our customers within life science such as the pharmaceutical industry, research institutions and hospitals. LGC Biosearch Technologies is certified according to ISO 9001 and ISO 13485.

At the Risskov site we are currently 35 employees, but we are in the process of expanding our production capacity. In this connection we will later this summer move to a larger site in Lystrup.

The company is part of the LGC Group with more than 4,200 employees worldwide.

Do you want to know more?

For further information regarding the position, please contact QA Manager, Louise Jensen, at tel.: 8732 3035.

Do you find the position interesting please submit your application and CV as soon as possible via the application link.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


QA Document Control Specialist

To our fast growing site in Denmark we are looking for a QA Document Control Specialist who supports the GMP production site in Risskov/Lystrup, Denmark to ensure Quality Management System, Customer, and Regulatory Requirements are met. This role is responsible for administrative and project based tasks within the Quality Assurance department. The role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. You are primarily responsible for the Batch Record Review and Document Control processes.

Areas of Responsibility: 

  • Review of batch production records for completeness and release
  • Review of analytical records and any supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures.
  • Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations.
  • Perform routine document control activities including creation and/or revision, processing, routing and review.
  • Assists in performing QC data review for batch record in-process and final QC approval.
  • Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance.
  • May be called upon to assist with the Supplier Qualification program.
  • Perform additional tasks, as assigned

Education/Experience: 

  • Preferably you are a trained Lab Technician (laborant/laboratorietekniker) or a professional from the health care system with administrative flair.
  • Working knowledge of quality systems and ability to apply GMPs in accordance with standards.
  • Familiarity with ISO 9001:2015, ISO 13485:2016 and 21 CFR 820.
  • Industry experience in managing document control processes and software.

Personality:

  • Quality conscious with strong attention to detail
  • Self-motivating personality
  • Excellent people skills
  • Able to successfully multi-task and prioritize in a fast paced environment
  • Good collaboration and communication skills
  • Positive attitude and a sense of humor.

About us

LGC Biosearch Technologies in Risskov is producing custom-made synthetic DNA and RNA oligonucleotides to support our customers within life science such as the pharmaceutical industry, research institutions and hospitals. LGC Biosearch Technologies is certified according to ISO 9001 and ISO 13485.

At the Risskov site we are currently 35 employees, but we are in the process of expanding our production capacity. In this connection we will later this summer move to a larger site in Lystrup.

The company is part of the LGC Group with more than 4,200 employees worldwide.

Do you want to know more?

For further information regarding the position, please contact QA Manager, Louise Jensen, at tel.: 8732 3035.

Do you find the position interesting please submit your application and CV as soon as possible via the application link.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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