GMP Compliance Coordinator

2 days ago

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

About PSC Biotech Corporation

We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

PSC Biotech Corporation is a leading Biotech Consultancy firm founded in 1996, headquartered in California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients in more than 23 countries worldwide.

We disrupt the conventional consultancy model by aligning our Employee Value Proposition as one of the unique selling points which include the opportunity to work with talented professionals operating in the Pharma/Biotech Industry. We offer permanent contracts of employment giving exposure to working in Top Pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition

We empower career development through Learning & Development in-house training and mentorship. Our goal is to create high-performing teams that can exceed our clients' expectations with regards to quality of all scalable and business unit deliverables.

The successful candidate will be responsible for supporting the Engineering Department in a GMP and Sterile Environment. This role ensures that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety, and reliable supply to our customers.

Key Responsibilities:

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

Requirements:

  1. Report, standards, policy writing skills required.
  2. Sterile filling processes and equipment experience preferred.
  3. Proficiency in Microsoft Office and job-related computer applications required; Lean Six Sigma Methodology experience desired.

Personal Qualities:

  • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
  • 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.
  • Self-motivated with a flexible approach.
  • Effective time management and multi-tasking skills; proven organizational skills.
  • Excellent attention to detail; data analysis.
  • Training skills; starter and finisher.
  • Troubleshooting skills; goal/results oriented.

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.

  • GMP Compliance Professional

    1 day ago

    Carlow, Ireland Psc Biotech Ltd Full time

    Key ResponsibilitiesAs a GMP Compliance Professional at PSC Biotech Ltd, you will be responsible for ensuring compliance with global policies, procedures and guidelines, as well as regulatory requirements. You will design/author/review/approve/executes qualification/validation documentation and cycle development studies, and engage with production,...

  • GMP Compliance Expert

    6 days ago

    Carlow, Ireland Psc Biotech Corporation Full time

    PSC Biotech Corporation is seeking an experienced GMP Compliance Expert to join our Engineering Department. In this role, you will be responsible for ensuring that our company's products meet the highest quality and safety standards.About UsPSC Biotech Corporation is a leading Biotech Consultancy firm with operations globally. We provide cloud-based software...

  • GMP Engineering Lead

    4 days ago

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

    About the Job:The GMP Engineering Lead is responsible for supporting the Engineering Department in a GMP environment. This role ensures that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety, and reliable supply to customers.Main Responsibilities:Lead deviations, out of tolerance conditions, and unexpected...

  • GMP Manufacturing Operations Expert

    5 days ago

    The Municipal District of Carlow, Ireland PE Global Full time

    We are seeking a skilled GMP Manufacturing Operations Expert to join our team. In this role, you will be responsible for supporting cleaning validation, including recovery/cleanability studies, and ensuring compliance with regulatory requirements and cGMP guidelines.The ideal candidate will have considerable experience in a comparable role, with experience...

  • Validation Engineer

    7 days ago

    The Municipal District of Carlow, Ireland PE Global Full time

    PE Global is seeking a highly skilled Validation Engineer to join our team in a GMP manufacturing environment.About the RoleThe successful candidate will be responsible for supporting Cleaning Validation, including Recovery/Cleanability studies, and will work closely with production, maintenance, and quality teams to ensure seamless execution of Cycle...

  • GMP Compliance Specialist

    3 days ago

    The Municipal District of Carlow, Ireland MSD Full time

    About the OpportunityThis is a fantastic opportunity to join a leading healthcare company and contribute to the advancement of manufacturing excellence and R&D across our Irish sites and global company network.About the JobWe are seeking a highly skilled Validation Process Expert to join our team. The successful candidate will have a strong background in...

  • GMP Compliance Expert

    4 days ago

    Carlow, Ireland Life Science Consultants (Lsc) Full time

    Opportunity OverviewWe are seeking a highly skilled Compliance Engineer to join our client's team in Carlow, Ireland.This contract opportunity is ideal for a quality professional with 3 years of experience in the pharmaceutical or biotechnology industry looking to take on new challenges and responsibilities.Key Responsibilities:Deliver quality oversight and...

  • Compliance and Quality Assurance Professional

    4 days ago

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

    Job Summary:We are seeking a highly skilled Compliance and Quality Assurance Professional to join our team at PSC Biotech Corporation. The successful candidate will be responsible for supporting the Engineering Department in a GMP environment.About the Role:This is a key position within our organization, requiring strong leadership skills and a deep...

  • GMP Manufacturing Expert

    3 hours ago

    Carlow, Ireland Life Science Consultants (LSC) Full time

    We are looking for a seasoned Validation Engineer to join our team at LSC and support a global Biopharmaceutical company in Carlow, Ireland. In this role, you will design, implement, and validate equipment and processes to ensure compliance with GMP.You will be responsible for creating qualification/validation documentation and cycle development studies, as...

  • Regulatory Compliance Specialist

    4 days ago

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

    Job Description:The Regulatory Compliance Specialist will be responsible for supporting the Engineering Department in a GMP environment. This role ensures that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety, and reliable supply to customers.Main Responsibilities:Direct and lead deviations, out of...

  • GMP Quality Assurance Manager

    14 hours ago

    Carlow, Ireland Life Science Recruitment Ltd Full time

    Job OverviewThis is an exciting opportunity for a highly motivated individual to join our team as a Regulatory Compliance Specialist in Tipperary. The successful candidate will support the Engineering Department in ensuring compliance with Good Manufacturing Practices (cGMP).Main Duties:Lead investigations into deviations, out of tolerance conditions, and...

  • Compliance Specialist

    2 days ago

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

    About PSC BiotechWho 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...

  • Validation and Compliance Expert

    4 days ago

    The Municipal District of Carlow, Ireland eTeam Full time

    Required Skills and QualificationsIn order to excel in this role, you will have considerable experience in a comparable role, operating as an individual contributor adding value to the business in a GMP manufacturing setting.Relevant Degree level, Technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical /...

  • Compliance Engineer

    5 days ago

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

    Industry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCity: CarlowState/Province: CarlowCountry: IrelandJob DescriptionAbout PSC BiotechPSC 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...

  • GMP Validation Engineer

    1 day ago

    The Municipal District of Carlow, Ireland LSC, Life Science Consultants Full time

    Key Responsibilities:As a Validation Engineer, your key responsibilities will include:Designing and developing qualification/validation documentation and cycle development studiesExecuting qualification/validation activitiesResolving technical issues during study executionProviding technical input into quality notificationsYou will work closely with...

  • Regulatory Compliance Expert

    2 days ago

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

    About PSC Biotech CorporationWe are a leading Biotech Consultancy firm founded in 1996, headquartered in California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients in more than 23 countries worldwide.Our company provides cloud-based software solutions for Quality Management and Regulatory Inspections,...

  • Compliance Engineer

    5 days ago

    Carlow, Ireland Life Science Consultants (Lsc) Full time

    LSC have a great contract opportunity for a Compliance Engineer to join a global Biopharmaceutical company in Carlow.If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for youABOUT THE PROJECT - KEY RESPONSIBILITIES: Provide quality oversight...

  • Sample Coordinator

    4 weeks ago

    Municipal District of Carlow, Ireland Life Science Recruitment Full time

    QC External Sample and Retain CoordinatorRK22735Contract – 11 monthsCarlowWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Responsibilities:Act as point of...

  • Compliance Specialist

    4 weeks ago

    Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    About PSC BiotechWho 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...

  • Compliance Engineer

    4 weeks ago

    Municipal District of Carlow, Ireland PSC Biotech Corporation Full time

    About PSC BiotechWho 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...