Change Control Co-ordinator

Change Control co-ordinator - Pharmaceutical - Sterile Manufacturing  HYBRID

World Leading Pharmaceutical  fill/finish vaccines facility have a contract requirement for an experienced Change Control Co-ordinator.

As Change Control Co-ordinator you will be involved in the management of the  change controls from initiation to closure, keeping track of all change controls for the group. The change controls will include  Process improvements, capital projects and Lean projects across multi-functions.

We are looking for candidates with change control experience ideally in GMP manufacturing, preferably GMP engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in change control management.

You will be working with  Project engineers to support internal and external manufacturing operations to remain operational, continuously improve and innovate. 

Responsibilities will include:

• Understand and progress change controls through  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.
• Answer questions from batch release, questions from completion of the annual product review, and provide information if needed to support the regulatory filings.
• 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
• Collaborate with multiple partners 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.

Qualifications, Skills & Experience Required  

• Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
• Change control experience ideally with  engineering 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
• 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

Hybrid Working: You will be required to be on site one day every 2 weeks.

If you fit the above and would like to discuss this role in further detail please call today and send your latest CV.