Collins McNicholas

Role Responsibilities:

Administration

  • Assist in the Day to Day running of production systems
  • Manage the workflows for the production log books, SOP’s and equipment work orders
  • Storing and controlling the HR documentation within the department
  • Control the issuing and archiving of the batch records, study plans, and log books
  • Tracking of the validation and product support documentation (including issuing document numbers) generated within the project
  • Scan batch records and validation documentation
  • Archiving documentation
  • Participate in both project and department meetings and the support of the meeting as needed in terms of schedule, agenda and minutes
  • The organization/support of the necessary tracking databases and the structuring of the administrative support, including filing and communications (memo’s)
  • Support EHS Compliance
  • Where applicable assist in the review of relevant logbooks (with assistance from supervisor)
  • Create PO’s for consumables and raw materials for the
  • project
  • Provide input to daily administrative operations to improve performance
  • Assist in the generating performance related data
  • Co-ordination/support to production on issuance of safety permits

Documentation

  • Be Attache PRO Coordinator for the project.
  • Approve CRs in line with First Pass Acceptance Guidelines
  • Route Documents for Review and Approval
  • Update SOPs as required
  • Management of withdrawal of documents on Attache PRO
  • Assist with the update of validation lifecycle documents, approving as required
  • Provide Training on system within department
  • Investigate issues/troubleshoot and escalate where appropriate
  • SOP Documentation, ensure that all SOP’s are in place, controlled and are available on request to the department manager
  • Archive documentation onsite and offsite and be point of contact for the recall / sending documentation offsite to Iron Mountain. Ordering supplies as needed.

Training

  • Maintain & assign training
  • Create/update/inactivate courses/modules as required
  • Manage SOP updates
  • Assist with the completion of Employee/Contractor Annual Qualification Reviews
  • File hard copy training records
  • Maintain instructor qualification records
  • Provide Training on system
  • Generate reports
  • Monitor Training
  • Investigate issues/troubleshoot and escalate where appropriate
  • Create / Update / Maintain Training Curriculums for project facility (operations & support personnel)

Purchasing / Finance

  • Create Purchase Orders
  • Create NPI Raw Material POs
  • Maintain workflows for invoices and action
  • Review open PO Reports and action
  • Review GRIR Reports and action
  • Assist with the setting up of new vendors on SAP and with updating vendor master data
  • Coordinate with vendors in relation to orders/delivery deadlines/issues

Compliance and Training

  • To work in compliance with regulatory requirements FDA, IMB, GxP, Safety and environmental legislation and FLI procedures
  • Organise and update the training files and support the implementation of an effective training programme.

Health & Safety:

  • All employees must be aware and understand the provisions of the Safety Statement & Standards Manual and the contents of all written safety procedures relevant to their areas of work. 
  • All employees are expected to engage in the applicable EHS&E programmes.

Role Requirements:

  • Third level qualification
  • 3-4 years’ experience in a similar role
  • Excellent organizational skills
  • Self-motivated and works well with minimal supervision
  • Fluent in English

 

For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email aisling.lane@collinsmcnicholas.ie

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