Engineering Compliance Specialist

About PSC Biotech

Who are we?

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.

Overview:

We are seeking an Engineering Compliance Specialist to
join our Engineering Department , supporting operations in a GMP and Sterile
Environment. This role is essential for ensuring compliance, safety, and
reliable product supply. Key responsibilities include generating and expediting
the review of Manufacturing GMP documentation such as deviation reports (QNs)
and corrective and preventative actions (CAPAs), leading Engineering change
controls and supporting permanent inspection readiness. The Compliance
Specialist will also author, edit, and review controlled documents, collaborate
within cross-functional teams to solve problems using Root Cause Analysis (RCA)
methodologies, and ensure timely completion of documentation to maintain compliance
with regulatory requirements.

11 Months of Contract

Remote/Hybrid/Onsite: Initially 4 days onsite - could
move to 3 after 6 months

Requirements

What you will do:

• Bring energy, knowledge, innovation, and leadership to
  carry out the following:
  
• Direct and/lead deviations, out of tolerance conditions
  and unexpected results, conducting failure analysis, root cause determination
  and implementing corrective and preventative actions.
  
• Supporting Engineering documentation review - e.g.
  electronic logs
  
• Supporting Audit Readiness activities.
  
• Supporting Internal Audit programs
  
• Collaborate with Engineering colleagues and other
  departments particularly IPT, Quality, EHS, Technical Engineering in completion
  of tasks and maintaining compliance posture.
  
• 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
  
• May be required to perform other duties as assigned.
  

What skills you will need:

• In order to excel in this role, you will more than likely
  have:
  
• Diploma or higher preferred, ideally in a related
  discipline.
  
• Would typically have prior-related work experience;
  ideally in a manufacturing GMP setting.
  
• Effective communication and interpersonal skills to
  interface effectively with all levels of colleagues in a team environment
  
• Knowledge of regulatory/code requirements to Irish,
  European and International Codes, Standards and Practices
  
• Report, standards, policy writing skills
  
• Sterile filling processes and equipment experience
  preferred.
  
• Proficiency in Microsoft Office and job-related computer
  applications
  
• Lean Six Sigma Methodology experience
  
• Effective communication and interpersonal skills to
  interface effectively with all levels of colleagues in a team environment, and
  with external customers
  
• Understand the specific responsibilities of all departments
  as they relate to one’s own department, understanding the business processes
  one’s department supports
  
• Effective time management and multi-tasking skills
  
• Proven organizational skills
  
• Excellent attention to detail