Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Carlow
State/Province Carlow
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin ****, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
Responsible for generating and expediting review andapproval processes for IPT GMP documentation including but not limited toQuality Notifications, CAPA close out records, IPT Standard OperatingProcedures and Standard Work Instructions and change controls.
Ensure thatobjectives are effectively achieved, consistent with requirements to ensurecompliance, safety and reliable supply to our customers.
Requirements
Accountabilities:
Support manufacturing activities through documentationgeneration, equipment and process investigations associated with non-GMPactivities and completion of quality notifications.
Provide input to the MESdevelopment process team on technical aspects of MES functionality and serve asMES SME within IPT
Be a document system expert; this will include documentreview, approval and document system work flow expedition.
Format, write,deliver and review necessary documentation in line with the standard approvalprocess, and facilitate others to do so.
Documents will include SOP's, SWI's,training documents, and change controls.
Support operation activities throughdocumentation generation, filing, tracking, auditing and efficient maintenanceof all associated databases including the maintenance, auditing and archivingof the process documentation system.
Support Batch release through timely Quality Notificationcompletion, Interim/summary report generation; meeting batch releaserequirements.
Raise CAPA's and conduct investigations.
Raise andinvestigate quality notifications using standard tools and methods, to resolvesystem issues e.g. FMEA, Fishbone diagrams, 5 why's etc.
; implement subsequentcorrective action through the change management system.
Complete Customer complaint investigations and ChangeControls and ensure they are closed out to support production activities in atimely manner in conjunction with the SCM team.
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.
Work collaboratively to drive a safe and compliantculture
May be required to perform other duties as assigned.
Assist in the management and/or assignment of IPTtraining if required
Skills and Knowledge:
Typical Minimum Education:
Bachelor's Degree or higher preferred; ideally in aScience, Engineering or other Technical discipline
Typical Minimum Experience:
Relevant experience and a particular skill set in theirarea of expertise that adds value to the business; ideally in a manufacturing,preferably GMP setting
Core Competences:
Technical:
SAP knowledge and experience required
Proficiency in Microsoft Office and job related computerapplications required
Knowledge of regulatory/code requirements to Irish,European and International Codes, Standards and Practices
Equipment and process validation
Sterile filling processes and equipment
Business:
Excellent communication, presentation and interpersonalskills, to interface effectively with levels of colleagues and with externalcustomers in a team orientated manner
Understand the specific responsibilities of all departmentsas they relate to ones department, understanding the business processes onesdepartment supports
Strong team skills, including ability to coach/developwork teams
Excellent training, facilitation and assessment skills
Strategy planning and development
Demonstrable analytical and systematic problem solvingskills
Flexible approach
Effective time management and multi-tasking skills
Proven organizational skills
Excellent attention to detail
Goal/results orientated
Leadership:
Focus on Customers and Patients
Act with Candor and Courage
Make Rapid, Disciplined Decisions
Drive Results
Build Talent
Demonstrate Ethics and Integrity
Reports to: Operations Coach (Manufacturing Support)
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