Process Support Specialist
1 month ago
- Industry Pharma/Biotech/Clinical Research
- Work Experience 4-5 years
- City Carlow
- State/Province Carlow
- Country Ireland
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.
We are looking for a Process Support Specialist
Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Principal Accountabilities:
- Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
- Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
- Be a document system expert; this will include document review, approval and document system work flow expedition.
- Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Documents will include SOP’s, SWI’s, training documents, and change controls.
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
- Support Batch release through timely Quality Notification completion
- Interim/summary report generation; meeting batch release requirements.
- Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
- Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
- Assist in the management and/or assignment of IPT training if required
Skills and Knowledge
- Typical Minimum Education
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Typical Minimum Experience:
- Relevant experience and a particular skill set in their area 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 computer applications required
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Equipment and process validation
- Sterile filling processes and equipment
- Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner
- Understand the specific responsibilities of all Carlow departments as they relate to ones department, understanding the business processes ones department supports
- Strong team skills, including ability to coach/develop work teams
- Excellent training, facilitation and assessment skills
- Strategy planning and development
- Demonstrable analytical and systematic problem solving skills
- Flexible approach
- Effective time management and multi-tasking skills
- Proven organizational skills
- Excellent attention to detail
- Goal/results orientated
- Focus on Customers and Patients
- Act with Candor and Courage
- Make Rapid, Disciplined Decisions
- Drive Results
- Build Talent
- Demonstrate Ethics and Integrity
#J-18808-Ljbffr
-
Process Support Specialist
5 days ago
Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Carlow State/Province Carlow 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,...
-
Operations Support Specialist- hybrid/D4
3 days ago
Ireland CPL Healthcare Full timeMy client in the tech space has an immediate requirement for Operations Support Specialist for an initial contract role. Hybrid working- Dublin 4. The successful candidate will proactively drive the end-to-end procurement process; monthly regional meetings to understand procurement needs e.g. onboarding new suppliers, contract requests, creation of...
-
Clinical Nurse Specialist/Candidate
6 days ago
Ireland Suir Engineering Full timeClinical Nurse Specialist/Candidate (Specialist Palliative Care) Marymount University Hospital & Hospice Location: On site / Cork, Ireland job type: Permanent / Full-time Sector and subsector: Medical & Healthcare | Nursing & Midwifery Annual Salary Range: from € 57,198.00 to € 67,621.00 Grade Clinical Nurse Specialist/Candidate (General)...
-
Process Engineer
1 day ago
Ireland Penspen Ltd Full timeProcess Engineer - Cork - Ireland Permanent Full Time Circa Euro 65000 (Negotiable) with exceptional flexible benefits package. Must have right to work in Ireland Penspen have an exciting opportunity for an experienced Process Engineer based in Cork, Ireland. You will have experience in the Oil & Gas industry, anything from Offshore to...
-
EHS Specialist
1 month ago
Ireland Apleona UK Full timeThe details for the selected vacancy are shown below. Advert Title EHS Specialist Advert Text Overall Purpose of the Job Reporting to the HSEQ Manager, the EHS Specialist will support the company EHS managementsystem. You will be responsible for providing technical support on all environmental, health and safetysystems to ensure compliance with all...
-
Customer Support Specialist
2 weeks ago
Ireland Aaron Full timeAaron.ai ist der Marktführer in KI-gestützter Patienten-Praxis-Kommunikation in Deutschland. Dabei setzen wir uns täglich für eine Welt ein, in der Patient:innen jeden Alters jederzeit direkten Zugang zur medizinischen Versorgung erhalten. Über 4.000 Ärzt:Innen gehen diesen Weg bereits gemeinsam mit uns. Bei Aaron.ai leben wir mit 70+ Kolleg:innen...
-
Payroll Specialist
4 weeks ago
Ireland Stryker Corporation Full timePayroll Specialist (12 Months FTC) page is loaded Payroll Specialist (12 Months FTC) Apply locations Cork, Ireland Limerick, Ireland Dublin, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R519551 Work Flexibility: Hybrid We are seeking a Payroll Specialist to join our dynamic and dedicated team on a 12 months Fixed Term...
-
ITSM Operations and Integration Specialist
4 days ago
Ireland PARETO SECURITIES AS Full timeITSM Operations and Integration Specialist The ITSM Operations and Integration Specialist will be part of Aeven’s Automation, AI & Tools division. This role combines the day-to-day platform support responsibilities of an ITSM Operations Specialist with the development and maintenance of integrations between ITSM systems as an Integration Specialist. ...
-
Analytics Specialist
3 weeks ago
Ireland Welocalize, Inc Full timeIf you have a Candidate Login already, but have forgotten your password please use the steps to reset your password. If you have forgotten your email login, please contact servicedesk@welocalize.com subject Workday Candidate Login When creating your Workday account and entering personal information like name, address, please do not use ALL CAPS. Thank...
-
Quality Operations Specialist
1 month ago
Ireland PSC Biotech Full timeDunboyne, Ireland | Posted on 01/01/2024 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dunboyne State/Province Meath 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...
-
Safety Specialist
6 days ago
Ireland PARETO SECURITIES AS Full timeDanish Refugee Council , one of the world’s leading humanitarian NGOs. DRC has been operating in Ukraine since 2014, currently DRC employs over 650 staff in Ukraine and will continue significant scale-up in 2024 to implement emergency response in the Protection, Livelihoods, Shelter/NFIs and Humanitarian Disarmament and Peacebuilding (humanitarian mine...
-
Senior Specialist, Technical Services
1 month ago
Ireland AstraZeneca GmbH Full timeThis is what you will do: The Senior Specialist Technical Services has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The Senior Technical Specialist will provide processing expertise to support the technology transfer, validation and routine commercial...
-
Quality Specialist
2 days ago
Ireland PSC Biotech Corporation Full timeTipperary, Ireland | Posted on 05/10/2024 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years 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...
-
Finance Systems Specialist
5 days ago
Ireland Linesight Full timeAs a Finance Systems Specialist at Linesight, you will work with highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. You will gain vast industry experience that will open doors for you, extend your skillset and expand your perspective. We will empower, support, and enable you to...
-
Pastry Sales Specialist
1 month ago
Ireland Develocraft Full timeLocation: Hybrid / Ireland job type: Permanent / Full-time Sector and subsector: Sales | Business Development Salary: Negotiable Salary Pastry Sales Specialist – Nationwide Our team at Sysco is the best at what they do, and it’s through your hard work, passion and dedication that we’ve been able to become the largest foodservice provider...
-
IT Security Specialist
1 month ago
Ireland Nimbis Full timeWe are seeking an IT Security Specialist Responsibilities Analysis of existing IT infrastructures Support of 1st + 2nd level support Security Admin of Active Directory, DNS, DHCP and GPOs VPN and firewall admin Creation of backup concepts, configuration and execution of data backups Virtualization with Hyper-V Responsibility and support of internal...
-
Process Engineer
5 days ago
Ireland Asset Recruitment Full timeref 01109 Process Engineer – Upstream/Downstream Process Role Provide technical expertise in Upstream/Downstream processing to offer support to the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. The successful candidate will be responsible for ensuring that manufacturing processes are validated and maintained...
-
German Legal Support Advisor
2 days ago
Ireland Talingual Full timeRole: German speaking Legal Operations Analyst Salary: €2,464 gross per month (€29,568 per year) + €200 per month targeted bonus taking it to €31,971 The company: Our client is a global outsourcing company – they have offices around the world and in Lisbon they have multiple sites where they support huge international clients and assist with...
-
Quality Assurance Specialist
1 month ago
Ireland PSC Biotech Corporation Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Carlow State/Province Carlow 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,...
-
Azure Virtual Desktop Specialist
1 month ago
Ireland PARETO SECURITIES AS Full timeWe are seeking a skilled and experienced Azure Virtual Desktop Specialist to join our team in Denmark. In this role, you will be responsible for designing, implementing, and managing Azure Virtual Desktop environments for our clients. Your expertise will be crucial in collaborating with stakeholders, configuring virtual desktop infrastructure, and...