Change Control Document Controller

  • Contract
  • Carlow

Website TPM05313

Summary:
Our client is a multinational Biopharmaceutical company based in the midlands looking for a Change Control Co-Ordinator who will be responsible for managing the change controls from initiation to closure, keeping track of all change controls for the group. The change controls will include but are not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. The suitable person will typically have prior related change control experience; ideally in manufacturing, preferably GMP setting with engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in change control management. The change control coordinator will work in conjunction with Project engineers to support internal and external manufacturing operations to remain operational, continuously improve and innovate. With an extensive range of facilities and environments, Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Responsibilities:

  • Understand and progress change controls through the Veeva Change Control Systems.
  • Change control SME for the group – keeping up to date with all updates attending meetings on a regular basis for Regulatory Updates.
  • Draft and prepare change controls with the relevant team members.
  • Attend and support the team at the relevant change control meetings required to discuss the change.
  • Progress change controls from initiation through to closure ensuring compliance to the site & global change control process.
  • Stay up-to-date with all the relevant upcoming and overdue change control records and aging records to react accordingly and ensure metric compliance.
  • Be able to answer questions from batch release, questions from completion of the annual product review, and provide information if needed to support the regulatory filings.
  • Coordinating with the Project Engineer to manage the change control work stream from concurrence(approval) to closure.
  • Constantly assessing the systems and processes to see what improvement that can be made to work smarter and more efficiently while all the time being compliant.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • Collaborate with multiple partners (e.g. Company network groups, third parties, vendors, quality, donor sites, Supply chain) in achieving excellence in technical transfer programmes.
  • May be required to perform other duties as assigned.
  • Manage and track any CAPAs that are associated with the group ensuring they are tracked appropriately by all owners.
  • Assist with management of EHS documentation associated with projects.

Qualifications & Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or ther technical discipline.
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in management of change controls.
  • Experience in leading through change would be an advantage.
  • Change Control experience with Veeva an advantage.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Proficient understanding and experience of Sterile filling processes and equipment especially aseptic processing an advantage.
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment an advantage.
  • Good shipping/Filter/Cleaning validation knowledge required.
  • Excellent report, standards, policy writing skills required.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Experience in audit preparation and execution desired.
  • Having a strong safety ethos.
  • Have a proven record of project management of change in a commercial site.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.