CPL in partnership with Pfizer are currently recruiting for a Business Support Specialist to join their Newbridge Site.
The Business Support Specialist balances the requirements of day to day support, implementation of system/operational process continuous improvements and corrective actions, preventive actions.
The ideal candidate will be self-driven and will be recognized as having a high level of knowledge/skill. Project management, tracking, monitoring, and implementing initiatives to improve efficiency will be a key requirement.
This role will support the current Manufacturing Operations in Pharma and requires a technical competence level to handle manufacturing issues.
What you will do:
- Working to implement a culture of Zero Defects through partnerships with Manufacturing Operations
- Coordinating local document periodic review process, and supply of controlled documents for manufacturing, e.g logbooks and Batch records.
- Providing subject matter expertise and support for business systems and processes, technologies and products for manufacturing process
- Authoring and Approval of SOP's, Forms, Protocols Batch Records, Training content & other documents for operations through collaboration with the various departmental SME's.
- Carry out organisational activities such as purchasing and co-coordinating communication information.
- Managing projects impacting Manufacturing Operations arising from Capacity Enhancement, Continuous Improvement/ Lean Management system, Technical Process Improvements.
- Backroom support with site audits for document retrieval and returns from Archives.
- Managing/supporting core meetings — Investigations Meeting, Metrics Meeting, Tech & Reg, Materials Review Board (MRB) meeting, Change control, Safety and Compliance, Hoshin (Project Management)
- Reporting/managing of compliance and metrics.
- Assisting with closure of Quality system investigations and implement process.
- CAPA's and performance improvements.
- Managing supplier complaints process.
To be successful in this role you will require: 1-3 years' experience working in cGMP manufacturing environment is essential. A track record of achievement and delivering successfully in a team environment is required. An ability to influence others positively is key.
The following would be considered an advantage:
- Experience of initiating business improvement projects or operations excellence projects.
- Familiarity with Change control, Investigation and Documentation Processes in a manufacturing environment.
- Previous experience with an electronic document management system.
- Excellent communication skills including computer literacy and ability to work independently and in teams.
- An ability to deal with process change and implement new effective processes.