Quality Specialist

NL  ‐ Onsite
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Description

A leading pharmaceutical organisation is currently recruiting for a Quality Specialist to join their Quality Operations Biotech Department.

To start: ASAP

Pay Rate: hourly rate to be decided

Languages: Must be fluent in English, Dutch a plus

The organisation

Quality Operations Biotech (around 60 people) is responsible for ensuring that our client's Manufacturing Division manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance to applicable local and international regulations. To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs of our client's Manufacturing Division as well as regularly interact with other Manufacturing Division sites.

The position

The BCR Specialist will be responsible for supporting Biological Critical Reagent (BCR) programs within the Biologics franchises. This support is critical to testing within Quality Control Laboratories. This position requires experience in general analytical biochemistry or immunochemical techniques. The BCR Specialist is responsible for managing the complete life cycle of reference materials, control samples and other materials used in support of release and stability testing of biological products.

Primary responsibilities include, but are not limited to the following:
  • Support transfer of Biological Critical Reagents of new Biological products from their Commercialization/MRL to Biotech BCR Hub;
  • Be responsible for one or more client Biological products, support complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of Biological Critical Reagents within the global Biologics franchises;
  • Support distribution (in time delivery) of Biological Critical Reagents to our client's laboratories, contract laboratories and regulatory agencies;
  • Provide bioanalytical support to their sites, Laboratories and other functional groups as needed. May also act as Critical Reagents representative for new product introduction as part of analytical sub team;
  • Provide bioanalytical support in responding to regulatory questions, authoring appropriate CMC sections or appropriate technical support during regulatory inspections;
  • Conform to current Good Manufacturing Practices (cGMP) as they apply to the functions of the group.
Qualifications

Bachelor degree in Biology, Chemistry, Biochemistry, or a related biological science with 2-4 years of experience in the areas below, or a Masters degree in Biology, Molecular Biology, Biochemistry, or a related biological science with 1-2 years of experience in all of the areas below is required for this position:
  • Experience in general biochemistry, analytical biochemistry or immunochemical techniques, as well as basic to strong technical knowledge and a high level of technical performance;
  • Basic understanding of factors affecting the precision, accuracy, and reliability of bioanalytical assays, including the mathematical treatment of data;
  • The ability to achieve productivity by managing time, priorities and personal effort in a fast-paced environment;
  • Detailed technical understanding of bioanalytical chemistry operations, including sample analysis strategies, instrumentation, and general laboratory operations. Understanding of innovative technologies is a plus.
Additional requirements also include:
  • Ability to work either independently as well as on teams and the ability to co-ordinate activities for multiple projects as need to meet timelines;
  • Project management skills;
  • Strong written and oral communication skills (in English and ideally Dutch), original and imaginative thinking in developing creative ideas. Technical writing experience and high attention to detail is a plus;
  • Strong technical and interpersonal skills and ability to work in a team environment;
  • Persuasion and influence skills;
  • Ability to clearly and candidly communicate;
  • Strong understand GLP/GCP/GMP regulations, with the ability to apply these practices daily; Innovative abilities and strong drive to improve; preferably Green Belt certification;
  • Proficiency in classical biochemistry assays and molecular biology techniques is highly desirable. Along with prior experience in bioanalytical testing;
  • Statistical Analysis experience with familiarity with JMP or Minitab.
Start date
2016-09-05
Duration
12 months
From
Quanta Consultancy Services
Published at
26.08.2016
Project ID:
1192874
Contract type
Freelance
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