Compliance Operations Manager

7 days ago


Carlow, Ireland Psc Biotech Ltd Full time

PSC Biotech Ltd. is a leading biotechnology consultancy firm with global operations, serving clients worldwide.

We provide cloud-based software solutions for quality management and regulatory inspections, pharmaceuticals contract manufacturing professionals, and metrology services.

Our employee value proposition includes the opportunity to work with talented professionals in the Pharma/Biotech industry.

We empower employees through learning and development, mentorship, and constant guidance to facilitate career progression.

We believe in creating high-performing teams that exceed client expectations regarding quality, scalability, and business unit deliverables, staying under budget, and meeting timelines.

Role Overview:

This role supports the Engineering Department in a GMP and sterile environment, ensuring objectives are effectively achieved, consistent with client requirements, to ensure compliance, safety, and reliable supply to customers.

Key Responsibilities:

  • Investigate and resolve deviations, out-of-tolerance conditions, and unexpected results, conducting root cause analysis and implementing corrective actions.
  • Analyze engineering metrics reports to identify trends and areas for improvement.
  • Develop and maintain documentation in line with the standard approval process, facilitating others to do so.
  • Collaborate with cross-functional teams to drive a safe and compliant culture.

Qualifications and Requirements:

  • Regulatory compliance knowledge and experience.
  • Excellent communication and interpersonal skills.
  • Report, standards, policy writing skills required.
  • Sterile filling processes and equipment experience preferred.
  • Proficiency in Microsoft Office and job-related computer applications required.

What We Offer:

We offer a competitive package, including a permanent contract of employment, opportunities for career growth and development, and a collaborative work environment.


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