QA specialist

7 days ago

Ireland PSC Biotech Full time
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, 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 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 to working in top pharmaceutical client sites in a diverse-cultural work setting.

Summary:

New opportunity as a QA Specialist for a candidate interested in working in a cGMP regulatory environment. The QA Specialist will be responsible for ensuring that the process for the manufacture of vaccines and biologics and supporting systems are in compliance with cGMP and the associated regulatory requirements. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers. Partner with colleagues cross-functionally/on and off-site to provide support and advice on a day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, systems compliance, etc.; thereby ensuring department/site is audit/inspection ready. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and procedures as well as regulatory requirements. The ideal candidate will have 3-5 years’ experience in a pharmaceutical/regulatory background with strong working knowledge of regulatory expectations, aseptic processing, environmental, and utility monitoring in a sterile manufacturing facility. The role will support quality systems activities and will liaise with the site to ensure systems are maintained and compliant as per global and local procedures.

Requirements

Bring energy, knowledge, and innovation to carry out the following:

  • Responsible for helping to ensure that the quality systems in use on site maintain complaint status.
  • Act as quality support for the site for relevant systems.
  • Ensure that quality issues are identified, addressed, and resolved in a timely manner.
  • Responsible for supporting issue close out on site and initiating/following up on corrective and preventative actions and continuous improvements.
  • Partner with colleagues cross-functionally to provide support and advice on a day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, etc.

What skills you will need:

In order to excel in this role, you will more than likely have:

  • Bachelor Degree or higher preferred; ideally in a related Science discipline.
  • Demonstrated ability in quality systems support.
  • Knowledge of EU/US quality related pharmaceutical regulations.
  • Experience of Sterile manufacture preferred.
  • Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in a quality system role.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices requirements.
  • Knowledgeable in Industry Best Practices for quality and compliance related topics.
  • Proven ability to effectively initiate and drive change.
  • Strong verbal and written communication skills, project management skills.
  • Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems).
  • Ability to work as part of a team to determine priorities.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to drive the completion of tasks.
  • Proven decision-making capability with accountability and responsibility.
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