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  • Job reference number:15185053
  • Client ID:RI/OS100117
  • Posted on:10-JAN-2017
  • Salary:Negotiable
  • Location:Clare, LIMERICK
  • Job type:PERMANENT

Biotech Production Specialist - Mfg Support LIMS/MR's

This position will require experience of working under time-sensitive conditions. The primary responsibility of the role is to administer, coordinate and manage all manufacturing MR/BR and LIMS sample manifests. The candidate will be working with LIMS, OPM, Scheduling, IPRO and doc compliance systems. The ideal candidate will be well organised, accountable and driven to succeed in a cGMP manufacturing environment.

Essential Duties and Responsibilities:

  • Generation & reconciliation of sample manifests through LIMS
  • Ensures availability of manufacturing records and batch sheets for upcoming manufacturing lots.
  • Work closely with site production schedulers and department area owners to agree & coordinate delivery and receipt of MR’s & BR’s to ensure that production schedule is adhered to
  • Control of completed manufacturing records between departments
  • Ensures all tasks are performed in a manner consistent with safety standards.
  • Assists/contributes in all areas of production as required.
  • Reviews, edits, completes, and revises completed batch records, Logbooks, and SOPs in accordance with cGMP standards & regulatory requirements
  • Documents all training and maintaining individuals training file.
  • Assist with training of new employees.
  • Act as back-up to the manufacturing scheduling process
  • Authoring, investigating and resolving quality deviations raised within the manufacturing support department
  • On time completion of assigned CAPAs
  • Participate cross functional team initiatives when required.
  • Gathers, trends, and analyzes process generated data.
  • Participates in defining robust process parameters during routine manufacturing campaigns.
  • Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns.
  • Creates process evaluation reports, process transfer documentation, and process characterization presentations.
  • Documents all training;
  • Assist with training of new employees.
  • Performs various tests and analytical procedures.
  • Performs in-process sampling, Quality Control Chemistry and Quality Control Microbiology.
  • Keeps process area stocked with essential equipment and components.
  • Ensures all tasks are performed in a manner consistent with safety standards.

Education and Experience:

  • BS/BA in Life Sciences or related field preferred; will substitute relevant work experience in lieu of degree requirement. Experience in an SOP, ISO, or similar regulated environment strongly desired.
  • Knowledge of Nautilus LIMS preferred, but experience with other LIMS software will be considered;
  • Knowledge of Zebra printers preferred, but not required;
  • Systems orientated

This job originally appeared on RecruitIreland.com