Documentation Coordinator Vaccines (100% remote)

Do you like working in a pharma context and does a 100% remote job opportunity sounds like music to your ears? Then this position as a Documentation Coordinator Vaccines is the right fit for you.

Please send me your resume (pdf): ben.veulemans@professionals.randstad.be

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  Bachelor’s Degree in engineering, science, or an equivalent technical discipline
• Minimum of 4 years working in an FDA-regulated environment, preferably in a pharmaceutical or biologics manufacturing environment
• Basic understanding of of aseptic processing principles
• Proficiency in computer applications such as Microsoft Office Suite
• Must have strong ability to maintain high efficiencies and accuracy in data entry
• Detail-oriented, with ability to quickly process complex information and make critical decisions with limited information at times
• Strong interpersonal, written, and oral communication skills

Experience / Knowledge Preferred:

• Experience in the NCL/OMCL process for vaccine government approval/release
• Previous experience in work environment under cGMP regulation highly desirable
• Experience in Vaccine Production/QA
• Proficient in applying process excellence tools and methodologies
• Experience working with external manufacturers or laboratories

As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extra’s like:

• Meal vouchers of 7
• Net representation cost of 50
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings

This big pharma company is looking for a Documentation Coordinator Vaccines to maintain an oversight of all drug products. This role is 100% remote.

Do you have some pharma experience and are you familiar with GMP and aseptic processing principles? Please send me your resume (pdf) and I help you one step closer to this challenging opportunity.

ben.veulemans@professionals.randstad.beor call me on 03 317 19 51.

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  Work with local Business Quality and Regulatory Affairs to understand documentation requirements for NCL/OMCLs (National Control Laboratory/Official Medicines Control Laboratory)
• Liaise with QA Account Managers and Contractors to obtain Drug Substance (DS) and Drug Product (DP) Certificates of Analysis, Certificates of Conformance, Master Batch Records etc. to prepare summary lot release protocols for submission to health agencies
• Retrieve in-process and release test data from eLIMS to to prepare summary lot release protocols for submission to health agencies
• Ensure all lot release protocol templates relfect accurate test methods / specifications; support change control process as needed
• Maintain high-level oversight of all DS and DP lots manufactured throughout the production network
• Provide support in answering the documentation questions of health agencies / resolve issues and discrepancies
• Complete and pass all applicable training required for access to quality and information management systems (i.e. ETS Trackwise, eLIMS etc.)
• Complete and pass all applicable Good Manufacturing Practice training and general quality management training
• Learning and remaining current with local regulations, guidelines and quality practices associated with the vaccines industry is required