Change Control Coordinator – Carlow

The Role

PE Global are recruiting for a Change Control Coordinator for our pharmaceutical client based in Co. Carlow. This is an initial 11-month contract role. Hybrid working options.

Job Responsibilities

• Understand and progress change controls through both IPI and the Veeva Change Control Systems.
• Change control SME for the group – keeping up to date with all updates attending local COP 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
• Keep track of all change controls metrics for the group.
• Partner with colleague’s cross-functionally (at site and above site) to ensure change controls are progressed in advance of the project need by date
• 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.
• Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make 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, IPT) in achieving excellence in technical transfer programmes.
• Manage and track any CAPA’s that are associated with the group ensuring they are tracked appropriately by all owners.
• Assist with management of EHS documentation associated with projects

Education and Experience

• Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other 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 IPI and 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

 Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***