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Upstream Documentation Specialist
4 months ago
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Job Title: Upstream Documentation Specialist
Role Description:
A fantastic and exciting opportunity has arisen for an Upstream Operations Support Engineer. The role will provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of manufacturing of batches. The Upstream Operations Support Engineer will support routine operations in the areas of safety and GMP compliance. The Upstream Operations Support Engineer will report to Upstream Operations Support Lead.
This position will play a pivotal and critical role in the manufacture of biologics-based medicines, including immuno-oncology.
Requirements
Role Functions:
Bring your energy, knowledge, and innovation to:
· As an Operations Engineer, you will work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations. This requires the delivery of process excellence and reliability across all areas of the IPT.
· Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.
· Collate and analyse downtime tracking data and link to problem solving.
· Provide Communication updates to manufacturing shift teams.
· Co-ordinate and support Audits including preparatory work.
· Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs).
· Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
· Creation of Protocols.
· Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s) as required.
· Co-ordination of Contractors and Visitors to BDS.
Experience, Knowledge & Skills:
· Self-motivated with excellent organizational skills
· Working knowledge of Upstream processes is highly desirable.
· Ability to interact with multiple stakeholders across numerous departments.
· Ability to work independently and as part of a team.
· Advanced soft skills e.g. Excel, PowerPoint to generate metrics, presentations as applicable
· Excellent communication skills and ability to highlight constraints and resource challenges
· Knowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirements.
Qualifications & Education:
Degree or 3rd level qualification (Science, Engineering).
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