Compliance Specialist

1 week ago

The Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

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 points which include 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 to 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 through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients' expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Note: Applicants must be eligible to work full-time here in Ireland. That means EU, UK as well as Stamp 4 VISA holders are all eligible.

Overview:

Responsible for supporting the Engineering Department in a GMP and Sterile Environment. Ensure that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety, and reliable supply to our customers.

Requirements

Role Function:

  1. Direct and lead deviations, out of tolerance conditions, and unexpected results, conducting failure analysis, root cause determination, and implementing corrective actions.
  2. Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
  3. Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, JSAs, PMs, and change controls.
  4. Accountable for leading investigation analysis, identifying true root cause, identifying gaps, and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks.
  5. 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.
  6. Support Audit Readiness activities.
  7. The role has an element of hybrid; initially, would be looking for a minimum of 4 days on-site – this could move to 3 days on-site after 9 months or so.

Experience, Knowledge & Skills:

Technical:

  1. Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
  2. Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  3. Report, standards, policy writing skills required.
  4. Sterile filling processes and equipment experience preferred.
  5. Proficiency in Microsoft Office and job-related computer applications required; Lean Six Sigma Methodology experience desired.

Business:

  1. Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.
  2. Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes one's department supports Customer service.
  3. Self-motivated with a flexible approach.
  4. Effective time management and multi-tasking skills; proven organizational skills.
  5. Excellent attention to detail; data analysis.
  6. Training skills; starter and finisher.
  7. Troubleshooting skills; goal/results oriented.

Leadership:

  1. Focus on Customers and Patients.
  2. Collaborate.
  3. Act with Candor and Courage.
  4. Make Rapid, Disciplined Decisions.
  5. Drive Results.
  6. Build Talent.
  7. Demonstrate Ethics and Integrity.

Qualifications & Education:

  1. Diploma or higher preferred, ideally in a related discipline.
  2. Typical Minimum Experience: Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
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