Upstream Documentation Specialist

3 weeks ago


Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

About PSC Biotech

Who we are?
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.

'Take your Career to a new Level'
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.

Employee Value Proposition
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 anUpstream Operations Support Engineer. The role will provide key operationalsupport to the Upstream shift teams to ensure right first-timeexecution/delivery of manufacturing of batches. The Upstream Operations SupportEngineer will support routine operations in the areas of safety and GMPcompliance. The Upstream Operations Support Engineer will report to UpstreamOperations Support Lead.

This position will play a pivotal and critical role in themanufacture of biologics-based medicines, including immuno-oncology.

Requirements

Role Functions:

Bring your energy, knowledge, and innovation to:

· As an Operations Engineer, you will work withthe Integrated Process Team (IPT) to ensure the effective and efficient on-timedelivery of batch production in Upstream Operations. This requires the deliveryof process excellence and reliability across all areas of the IPT.

· Support Shift Operations team to consistentlydeliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics,Production Plan, OEE, compliance and team training, including coordination ofdaily production activities.

· Collate and analyse downtime tracking data andlink to problem solving.

· Provide Communication updates to manufacturingshift teams.

· Co-ordinate and support Audits includingpreparatory work.

· Coordinating and authoring Quality Notificationsand Corrective and Preventive Actions (CAPAs).

· Ensuring accurate and timely documentation andupdates to maintain compliance with quality standards and regulations.

· Creation of Protocols.

· Creation and revision of Standard operatingProcedures (SOPs) Work Instructions (WI's) as required.

· Co-ordination of Contractors and Visitors toBDS.

Experience, Knowledge & Skills:

· Self-motivated with excellent organizationalskills

· Working knowledge of Upstream processes ishighly desirable.

· Ability to interact with multiple stakeholdersacross numerous departments.

· Ability to work independently and as part of ateam.

· Advanced soft skills e.g. Excel, PowerPoint togenerate metrics, presentations as applicable

· Excellent communication skills and ability tohighlight constraints and resource challenges

· Knowledge of Lean Six Sigma and Leanmethodologies, with an understanding of regulatory requirements.

Qualifications & Education:

Degree or 3rd level qualification (Science, Engineering).

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