- 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, 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 & Evaluate manufacturing metrics and performance indicators to proactively identify risks, out-of-trend and quality issues.
- Investigate deviations with responsibility to interface with TAS, 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, eQuality and mai® systems. The timely closure of these actions has high priority for the role.
- Third level degree qualified in a scientific, chemical, engineering or equivalent discipline.
- 5 years' experience in a manufacturing environment within the pharmaceutical industry.
- Qualification or experience of biotechnology or bioprocessing is a plus.
- Dependability - being reliable, responsible, and fulfilling obligations.
- Attention to Detail - being careful about detail and thorough in completing work tasks.
- Cooperation - being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Initiative - a willingness to take on responsibilities and challenges.
- Ability to work in a matrix organization to leverage expertise from other functions and departments.
- Ability to work quickly, proactively and independently without close supervision.
- Self-disciplined and self-motivated and have the ability to comprehend the extensive production operations and schedules.
- Strong verbal and written communication skills.
- Strong Excel, Word and PowerPoint skills.
- Ability to navigate in documentation management systems, such as, eQuality, LQT, Mai® etc.
- Team orientation with the ability to influence others.
- Flexibility essential.
- Strong influence and persuasion skills, bias for action, execution and delivering business impact and results
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The Life Science Specialists