Operations Supports Specialist
Operations Support Team of Specialists are system and operational process subject matter experts (SME’s). The Operations Support Specialist balances the requirements of day to day support, implementation of system/operational process continuous improvements (CI) and corrective actions, preventive actions (CAPA’s).
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 Drug Substance and requires a technical competence level to handle manufacturing issues, and the ideal candidate should have experience in executing projects in line with lean / six sigma tool and techniques.
- Working to implement a culture of Zero Defects through partnerships with Manufacturing Operations
- Demonstrating company values and Pfizer competencies
- 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
- Providing leadership in the use of OE and Lean principles to optimise our technical and business processes
- 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 and MRB.
- Supporting audit preparation and Inspection backroom
- 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.
Third level Qualification in Science, Engineering or equivalent is preferred, though not essential.
Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
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.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
- Demonstrate the GC OWNIT values
- Adhere to all HR Policies as appropriate
- Personal Development plans focus on the 70:20:10 guidelines
- CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
- Proactive engagement with key stakeholders.
- Best practices developed and shared with other teams /sites.
- Best practices actively sought and copied.
- Proactive & effective communication within and different functional groups in the Operating Unit
Please send your CV to email@example.com or call us on 01-4569899 for a confidential chat