Documentation & Quality Specialist

at  Fastnet Recruitment

Cork, County Cork, Ireland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate28 Jun, 2024Not Specified30 Mar, 2024N/ATechnical Writing,Management Skills,Documentation,Regulatory Requirements,Communication SkillsNoNo
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Description:

REQUIREMENTS:

  • Bachelor’s degree in a Technical, Quality or Engineering qualification or equivalent work experience.
  • Experience in documentation management, technical writing, or quality assurance roles.
  • Strong knowledge of documentation best practices and standards.
  • Excellent written and verbal communication skills.
  • Attention to detail and the ability to ensure the accuracy of documentation.
  • Analytical mindset with the ability to identify process improvement opportunities.
  • Strong organisational and time management skills.
  • Familiarity with regulatory requirements and compliance standards relevant to the industry (IATF 16949 and ISO 13485 Quality Management Systems would be an advantage but not a necessity).

Responsibilities:

  • Develop and maintain documentation standards, templates, and guidelines.
  • Review customer specific requirements and develop QC inspection reports, inspection plans and verification of test data.
  • Maintain all drawing/component changes and ensure the QC documentation associated with each change is up to date.
  • Review customer drawings and specifications and liaise with manufacturer technical team
  • Create, review, edit, and update various types of documentation, including Manufacturing Control Plans, standard operating procedures, work instructions, and technical specifications.
  • Component inspection and validation of manufacturing samples.
  • Project management of new product introductions.
  • Implement and maintain quality management systems, policies, and procedures.
  • Conduct audits and inspections to assess compliance with quality requirements.
  • Ensure compliance with relevant regulatory requirements and industry standards.
  • Coordinate and support internal and external documentation and quality management audits.
  • Participate in the resolution of audit findings and implementation of corrective actions.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Clinical Pharmacy

Graduate

A technical quality or engineering qualification or equivalent work experience

Proficient

1

Cork, County Cork, Ireland