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Compliance and Systems Development Technician

Job description

We are looking for a CSD technician to join the ranks of an international pharmaceutical manufacturer in Dublin.

This role is responsible for applying best practice documentation tools to manage production documentation through E-doc’s. To investigate deviations / Non-conformances through trackwise and assign CAPA’s to prevent re-occurrences.


The role will support the new product introductions to the site. The CSD technician adheres to all applicable laws and regulations as well as internal Company policies and procedures in the performance of the job role and applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfillment of the assigned performance targets.


The CSD technician is responsible for the safe, compliant, and efficient execution of job duties in a team environment.

Contact

If you are interested in this job apply below. I also have more senior or indeed junior roles within Engineering, QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, and biologics companies. Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius "at" sigmar.ie

Projects Involving

  • Task risk assessments within OSD as required.
  • Chemical risk assessments on new and existing A.P.I’s and raw materials.
  • Atex Sampling.
  • Compression tooling maintenance programme.
  • 5 ‘s projects.
  • OpEx system improvement projects
  • Operations dashboard update

Job Activities

  • Liaise with Operations in investigation checklists, deviations (Non-Conformances) and or associated investigations.
  • Provide technical and clerical support to the production team in the preparation of documentation, collation of data and tracking of investigations.
  • Control the flow of documentation within the E-doc’s for generating, authoring, reviewing, tracking, and approving cGMP documentation.
  • Liaise with QA to ensure that GMP standards are maintained in line with current SOP’s, batch documentation, and licenses.
  • Recognize and report to immediate supervisor any issues or deviations from accepted standards.
  • Provide status updates on own activities and productivity challenges according to defined procedures.
  • Seek process innovation and continuous process improvement.
  • Carry out and assist in the on-going training of new and existing personnel, as appropriate.
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near miss.

Necessary Experience for this Job

  • 2 years of related experience in pharmaceutical manufacturing and distribution environment with at least 1 years direct experience in technical writing.
  • Experienced in aligning individuals and teams to business objectives.
  • Current understanding and application/interpretation of GMP, CFR Title 21, and other regulatory guidance in a GMP pharmaceutical manufacturing environment
  • Working knowledge of manufacturing practices such as Lean, Six Sigma. White belt, green belt, Op Ex.

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