Profile of Role:
The Process Flow Specialist is responsible for removing all blockages to making the process flow. The PFS role is to make the process and the equipment flow at the same speed. This means that there is a real integration of process and equipment and the PFS will coordinate all activities.
The role is working on a 3 cycle shift basis.
Main duties and responsibilities:
- Co-ordinator of operator activities on shift to ensure efficient operation of production processes.
- Co-ordinator of all process and equipment schedules in the process and tank farm areas.
- Reviewing BMRs (Batch Manufacturing Records), Recipes and Process related documentation. Support real time batch record review.
- Drive productivity initiatives focusing on yield improvement, minimizing cost and maintaining process consistency.
- Generate and evaluate manufacturing metrics and performance indicators to proactively identify risks, out-of-trend and quality issues.
- Investigate deviations with responsibilities and Quality approvers. Focus on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate. As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
- Originate and manage the change controls for processes.
- Responsible for the update and maintenance of GMP documentation for the manufacturing process –BMRs, SOPs, and WIs. Ensure that documentation complies to GMP and EHS regulations.
- The PFS is responsible for the training program for operators. The requirement is to ensure that there is a cross training program in place to develop operators, to provide full cross training cover for all processes and to allow for altered plans when abnormal variation occurs in the process.
- Participate in Regulatory Authority GMP inspections and audits.
- The PFS is responsible for CAPAs and RA’s assigned to the production process in the LQT and eQuality systems. The timely closure of these actions has high priority for the role.
- Regular cross functional interactions on site in Cork and other European company
Education and Experience:
- Third level degree qualified in a Chemical, Engineering, Science or equivalent discipline.
- 5 years’ experience in previous Production environment in an API/Bio environment essential
- Qualification or experience of biotechnology or bioprocessing is a plus.
- Strong interpersonal skills
- Experience in an API/Bio environment essential
- Strong written skills as some Technical Writing duties are included
- Ability to work on own initiative
- Ability to work as part of a team
- Ability to work quickly, proactively and independently without close supervision.
For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to firstname.lastname@example.org