Manufacturing Operations Specialist

PSC Biotech Corporation; Cork; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Career development opportunities

In-house training and mentorship

Job summary

PSC Biotech Corporation in Cork, Ireland is looking for a professional with over 5 years of operations experience to support Process Team Leads. Key responsibilities include managing ERP production efforts and handling quality management system controls.

The ideal candidate will have a deep understanding of ERP systems and possess strong communication skills. The company offers a permanent contract with opportunities for career development in a dynamic work environment.

Qualifications

• 5+ years of experience in an Operations and regulated environment.
• Working understanding of ERP systems and related processes.

Responsibilities

• Provide direct support to Process Team Leads across products.
• Manage ERP aspects for production efforts at CMOs.
• Handle change controls within the Quality Management System.
• Support continuous improvement activities aligned with objectives.
• Perform root cause analysis and implement corrective actions.

Skills

Understanding of ERP systems (e.g. SAP)

Lean/Six Sigma/Continuous Improvement tools

Excellent written and verbal communication skills

Organizational skills

Cross-functional team engagement

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, 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 through 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.

Requirements

Responsibilities:

• Provide direct support to Process Team Leads acrossCommercial & Clinical products (Small Molecules, Biologicals, Drug Substance, Drug Product and Packaging operations on targeted/prioritized activities.
• Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.).
• Own and manage prioritized change controls and deviations within the Quality Management System (QMS) to effective on time closure and no impact on supply.
• Consolidation and issuance of key performance metrics per Process Team.
• Provide back-up support for Process Team Leads where necessary (e.g. holidays).
• Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings.
• Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate.
• Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure).
• There may be a need for this person to execute operation tasks with a view to eliminating or reducing the number of touchpoints associated with a task.
• This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.

Experience Required:

• Minimum requirement of 5 years’ experience within an Operations and regulated environment.

Required Skills:

• Will have a working understanding of ERP systems (e.g. SAP).
• Will have a good working understanding of the processes/unit operations assigned to the team.
• Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
• Experience in lean/six sigma/continuous improvement tools and techniques.
• Excellent written and verbal communication skills.
• A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.