Manufacturing Specialist (Senior)

  • Dublin
  • Temporary 12 months
  • JO-1901-64194_1548417315

Summary

Responsibilities

  • Develop, review and update production Standard Operating Procedures.
  • Develop, review and update master/generic batch records, bills of materials etc.
  • Develop, review and update Product Quality Risk Assessments
  • The Manufacturing Specialist will also function as the Manufacturing point of contact on
  • New Product Introduction (NPI) Projects and be responsible for:
    • Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones.
  • Lead Product Team meetings.
  • Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches
  • Hold people to account for delivery and behaviours within Product team
  • Function as the site interface between the Product Delivery Teams (PDT's), and ADL Senior Management.
  • Author, Reviewing and Approving new training materials.
  • Develop, review and update Protocols for manufacturing activities.
  • Documentation and approval of protocol deviations for manufacturing activities.
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
  • Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
  • Liaise with Process Development regarding documentation changes in an effective and timely manner.
  • Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP's for submission to the Product Lead.
  • Provide technical and clerical support to the production team in the preparation of documentation, collation of data.
  • Own and lead change controls as required by the NPI Project Team.

Requirements

  • Bachelor's Degree in Science or Engineering and 3+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • Detailed technical understanding of fill/finish operations
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong technical writing and presentation skills
  • Ability to be flexible and manage change
  • Ability to communicate and collaborate with technical and management staff
  • Project Management experience

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