Industry Pharma/Biotech/Clinical Research
Work Experience 1-3 years
City Carlow
State/Province Carlow
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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.
Overview:
As part of the IPT team, perform various production andoperations related tasks as part of an empowered team to aid in the manufactureand reliable supply of product.
Ensure that objectives are effectivelyachieved, consistent with requirementsto ensure compliance, safety and reliable supply to our customers
Requirements
Key Accountabilities:
With a RFT mindset operate and/or monitor productionactivities and support equipment, using MES/DCS and PLC based systems, toensure optimum equipment uptime and target outputs.
Equipment will include, yetis not limited to, parts washers, autoclaves, portable tank CIP/SIP/storagepanels, Vial Washer, Depyro Tunnel, Debagger and filling machines
Clean room cleaning, housekeeping and materialsmanagement in all production areas while focusing on continuous processimprovement using Lean Principles.
Fully Certified and Proficient on all Equipment,Processes and Tasks in the room.
Knowing factory priorities/schedule through RTMS.
Actingproactively without direction.
Manage equipment flow, including tracking soiled andclean hold times, proper labeling and inventory management of clean and sterileequipment using Kanbans and automated MES system to set QC status and expiry ofsterile equipment.
Maintain process equipment, completing preventativemaintenance and equipment troubleshooting and repairs where qualified toperform tasks.
Participate effectively in writing/revising/ rolling outaccurate operational procedures, training materials for various IPT systems;ensure all work is carried out in line with same.
Support continuous improvement by active participation ininvestigations and investigation reports, execution/development of changecontrol, and contribution to Kaizen events and projects as appropriate.
Performroot cause analysis, using standard tools and methods, to resolve system issuese.g.
FMEA, Fishbone diagrams, 5 why's etc.
; implement subsequent correctiveaction through the change management system.
Highlights roadblocks or issues from a people, safety,quality or delivery perspective in a timely manner.
Able to perform routine day to day problem solving forassigned area independently or when working as part of a team
Engage in Tier 1 process at both start and end of shift.Asking relevant questions and providing detailed information
Required to comply with Global Policies, Procedures andGuidelines, regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day to day activities and all applicablejob functions.
Take ownership of your own safety & adhere to allsafety procedures and programs.
Obtain and Maintain all required safety certificationsindependently.
Work collaboratively to drive a safe and compliantculture.
May be required to perform other duties as assigned.
Job Requirements:
This role is a site-based role.
This a 24/7 shift role.
Clear understanding and demonstrated cleanroom, sterilebehaviors & ALCOA Principles
Highlights roadblocks or issues from a people, safety,quality or delivery perspective in a timely manner Highlights roadblocks orissues from a people, safety, quality or delivery perspective in a timelymanner
Eager to learn and progress and take feedback
Flexible and engaged in Shift Versatility.
Involved in training fellow work mates
Engaged in Enablon
Manual Handling, Material transfer & Pallet truckCertifications
PSA/Airlock Management.
Knowing what good looks like.
Engaged in TAT and a clear understanding of zones andexpectations
Understanding of logging Down Time and using SEEQ
Validations, Tech Eng & Maintenance support whererequired.
Basic Batch review/release & PO Closures.
1 Improvement Project or OPPs completed Per Year
Educational and Experience Requirements
Typical Minimum Education: Leaving Certificate orequivalent required;Apprenticeship, Certificate or Diploma preferred; ideallyin a related discipline
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