- Planning and organizing ; Problem solving ; Attention to details
- Quality Oriented, a team player and have the ability to follow work procedures and rules
- Ability to work under pressure
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MAIN PURPOSE OF JOB
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To support operations on quality related matters and projects ensuring streamline and effective collection of quality related data, effective and timely implementation of quality projects as well as the compliant use of quality tools.
To support the pharmaceutical structure in production as functional leader.
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Key responsibilities and tasks:
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Execution of routine activities
- Batch Records Flow: supports and coordinates core processes (Production) as well as supportive processes (Supply Chain, Technical Services, Quality Control, etc) on filling batch records on a scientifically, compliant and timely manner ensuring also data integrity through enabling inter-department communication, mentoring, coaching and monitoring the overall process.
- Batch Master Records: strives and suggests lean batch master records elaboration in order to streamline and ensure effectiveness of data collection on a GMP compliant and timely manner.
- Quality Tools: supports and coordinates core processes (Production) as well as supportive processes (Supply Chain, Technical Services, Quality Control, etc) on handling and filing of events, change controls, complaints, etc on a compliant, scientifically based and effective manner, through inter-department communication enabling, mentoring, coaching and assisting on investigations and impact assessments.
- Pharmaceutical Production Structure: ensures that the pharmaceutical production structure has the necessary competence and training as well as an understanding of their responsibilities through training, mentoring and coaching. Train the pharmaceutical staff on the principles on “Right First Time”
- Quality Projects: coordinates and strives for effective and timely fulfilment of the quality projects of his/her responsibility.
- Define corrective and preventive actions to close identified gaps to improve the process.
- Contributes to production investigations and gives guidance to production pharmaceutical staff with regards to Root Cause Analysis.
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