Regulatory Compliance Specialist

1 week ago

Cork, Cork, Ireland TN Ireland Full time

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team in Cork. As a member of our quality team, you will play a vital role in ensuring the quality of our products and services.

Your primary responsibilities will include:

  • Supporting quality systems, assisting with batch release process of drug product and pack label finished goods orders produced by external Contract Manufacturing Organizations.
  • Ensuring quality oversight of the supply chain, manufacture, and packaging of products in various Contact Manufacturing Organizations.
  • Reviewing Manufacturing/Packaging batch records as applicable and relevant Quality Control documentation prior to recommending final batch release.
  • Reviewing and approving standard operating procedures, master batch records and product specifications.
  • Providing quality oversight of Deviation and Investigation reports to ensure root causes have been identified and corrective actions have been implemented.
  • Providing quality oversight of Change Control ensuring scope of record is clear and implementation activities are robust and timely.
  • Supporting proactive continuous improvement of quality systems by identifying efficiencies from systematic and compliance perspective.
  • Assisting with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
  • Supporting regulatory requests and inspections, both internal and external.
  • Supporting new market launches.
  • Reviewing template data and preparing CCFP for forward processing.
  • Preparing lot files to support batch release.
  • Updating relevant quality technical agreements as required.
  • Supporting external customer complaints as necessary.

Requirements

A Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

Relevant experience working in a Quality function in the pharmaceutical or biotechnology industry or combination of experience and educational background that may otherwise satisfy the requirements of this role.

Ability to comprehend technical information related to equipment, manufacturing processes, and regulatory expectations.

Desirable experience participation in regulatory inspections.

Ability to speak, present data, and defend approaches in front of audiences and inspectors.

Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.

Excellent interpersonal skills with ability to work as part of dynamic team and efficiently engage interdepartmentally and with external CMO's.

Excellent written and verbal communication skills.

Strong organizational skills, including ability to follow assignments through to completion.

Proficiency in PC skills such as Excel, Word, PowerPoint.

BioMarin is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

  • Global Compliance Specialist

    7 days ago

    Cork, Cork, Ireland Compliance & Risks Full time

    Job OverviewWe are seeking a highly skilled and experienced professional to join our team as a Global Compliance Specialist. This is an exciting opportunity for individuals who are passionate about compliance and risk management.About UsCompliance & Risks is a leading provider of regulatory compliance solutions, supporting businesses across diverse...

  • Regulatory Compliance Specialist

    4 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Life Science Recruitment is seeking a highly skilled Regulatory Compliance Specialist to join our client, a pioneering medical device company. This role is ideal for an individual with a strong background in regulatory affairs and a passion for ensuring compliance with medical device regulations.About the RoleThis Regulatory Compliance Specialist will be...

  • Regulatory Compliance Specialist

    1 day ago

    Cork, Cork, Ireland TN Ireland Full time

    TN Ireland is looking for a Regulatory Compliance Specialist to work within our QC Lab Services Team. The successful candidate will have a strong understanding of regulatory requirements and experience working within regulated industries.Key Responsibilities:Support the implementation of regulatory compliance initiatives.Monitor and report on compliance...

  • Regulatory Compliance Specialist

    24 hours ago

    Cork, Cork, Ireland TN Ireland Full time

    Job OverviewTN Ireland is seeking a highly skilled Regulatory Compliance Specialist to join their team. This exciting opportunity will allow the successful candidate to utilize their expertise in regulatory compliance and risk management to drive business growth while ensuring adherence to relevant laws and regulations.Key ResponsibilitiesProvide strategic...

  • Regulatory Compliance Specialist

    1 day ago

    Cork, Cork, Ireland TN Ireland Full time

    We are seeking a skilled Regulatory Compliance Specialist to join our team at TN Ireland. The successful candidate will be responsible for supporting the maintenance of our Electronic Quality Management System and collaborating with the quality team to achieve key performance indicators (KPIs).The ideal candidate will have a systematic and thorough approach...

  • Regulatory Compliance Specialist

    4 days ago

    Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    **Job Description**: We are seeking an experienced Regulatory Affairs professional to join our team in Cork, Ireland. As a Regulatory Compliance Specialist, you will be responsible for ensuring the company's medical devices comply with relevant regulations and standards.The ideal candidate will have a strong understanding of medical device regulatory...

  • Regulatory Compliance Specialist

    6 days ago

    Cork, Cork, Ireland Recruitment by Aphex Group Full time

    About the RoleThe Regulatory Compliance Specialist is responsible for ensuring that all aspects of our operations comply with relevant regulations and industry standards. This includes reviewing and implementing new procedures, conducting audits, and providing training to staff.

  • Regulatory Compliance Specialist

    4 days ago

    Cork, Cork, Ireland Recruitment by Aphex Group Full time

    Job OverviewWe are seeking a skilled Regulatory Compliance Specialist to join our team at Recruitment by Aphex Group.About the RoleThe primary function of this position is to ensure compliance with Good Manufacturing Practice (GMP) regulations and Company SOPs. This role will be responsible for reviewing and approving production and analytical documentation,...

  • Regulatory Compliance Specialist

    24 hours ago

    Cork, Cork, Ireland TN Ireland Full time

    Quality Assurance RoleWe are seeking a highly skilled QC Specialist NPI to join our team in Ireland. As a key member of our quality assurance department, you will be responsible for ensuring the quality and integrity of new product introductions.Key Responsibilities:Quality Assurance: Ensure compliance with regulatory requirements, coordinate and plan...

  • Regulatory Compliance Specialist

    4 days ago

    Cork, Cork, Ireland Teleflex Full time

    About UsTeleflex is committed to improving the health and quality of people's lives through its medical technologies. As a global provider of innovative solutions, we aim to become the most trusted partner in healthcare. Our diverse portfolio includes products and services in various therapy areas, and we strive to empower the future of healthcare.Job...

  • Regulatory Compliance Specialist

    3 days ago

    Cork, Cork, Ireland Catalyx Full time

    About CatalyxWe're committed to attracting the best global talent and creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. Our team is dedicated to delivering world-class solutions that enhance efficiency and drive success.The QA Specialist RoleThis QA Specialist position plays a crucial role in ensuring the...

  • Regulatory Compliance Manager

    1 day ago

    Cork, Cork, Ireland TN Ireland Full time

    Job SummaryQC Compliance Specialist RoleWe are seeking a highly skilled QC Compliance Specialist to join our team at TN Ireland. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards in our manufacturing environment.

  • Regulatory Compliance Specialist

    18 hours ago

    Cork, Cork, Ireland Enable Ireland Full time

    We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Enable Ireland. In this role, you will be responsible for ensuring compliance with all relevant regulations and legislation across our Services and Corporate Divisions.The successful candidate will have a relevant qualification in administration or a related field and a...

  • Compliance Specialist

    5 days ago

    Cork, Cork, Ireland Compliance & Risks Full time

    Compliance & Risks is the leading provider of market access and product compliance SaaS solutions. As a Sales Development Representative, you will be responsible for developing new business while growing your own career with Compliance & Risks.">">This is an exciting opportunity to join one of Ireland's fastest expanding SaaS companies, working with global...

  • Regulatory Compliance Specialist

    22 hours ago

    Cork, Cork, Ireland Westbourne It Global Services Full time

    Welcome to Westbourne It Global Services:We're a leading global provider of innovative solutions, and we're looking for talented professionals like you to help us deliver exceptional results.About the Job:This exciting opportunity as a Qa Specialist offers the chance to work in a dynamic environment where collaboration, innovation, and quality excellence are...

  • Regulatory Compliance Specialist

    1 week ago

    Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full time

    About the Role:Pale Blue Dot Recruitment is seeking a seasoned Regulatory Compliance Specialist - Medical Devices to join our client's team. The successful candidate will be responsible for ensuring compliance with all regulatory requirements and developing effective regulatory strategies to support product development and submissions.The ideal candidate...

  • Regulatory Compliance Expert

    2 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Company OverviewMy client, a leading medical device company, has developed a groundbreaking single-use product addressing pain points in surgical tympanostomy procedures. This innovative solution targets the most common procedure performed on children.About the RoleThis exciting opportunity involves ensuring compliance with regulatory requirements and...

  • Regulatory Compliance Specialist

    1 day ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Company OverviewWe are a leading manufacturer and distributor of X-ray and MRI contrast media for internal and external customers worldwide.Our Pharmaceutical Diagnostics (PDx) business supports the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time.We employ approximately 600 staff at our...

  • Senior UX Designer

    1 week ago

    Cork, Cork, Ireland Compliance & Risks Full time

    **Our Vision**We envision a future where compliance is simplified through innovative technology and human-centered design. At Compliance & Risks, we strive to deliver cutting-edge solutions that enable our customers to achieve their goals while ensuring regulatory compliance.We are looking for an exceptional **Growth Design Director** who will spearhead the...

  • Regulatory Compliance Manager

    22 hours ago

    Cork, Cork, Ireland Scientificjobs Full time

    Scientificjobs is a leading provider of X-ray and MRI Contrast Media for internal and external customers worldwide. We are committed to delivering the best-in-class supply chain, ensuring the right dose reaches the right patient at the right time.Our Pharmaceutical Diagnostics (PDx) business operates a 24/7 operation at our campus in Cork, employing...