The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned and perform the duties outlined below
In this role, a typical day might include the following:
• Support CMC/Combination...
..., Limerick has a fantastic opportunity for an experienced Front Office Manager to join their exceptional and expanding team and oversee... ...healthy with our Bike to work scheme
Xmas savings club
On site parking
Uniform provided.
Great National South Court Hotel...
...System Specialist participates in maintaining site compliance of operations inclusive of but... ...QA Validation in accordance with mandated regulatory requirements and site expectations. The... ...general mentorship.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)....
...and/or processes across multiple areas and sites
Owns processes with ability to act as... ...as integral resource or team member for regulatory and internal audit and inspection logisticsCOMPLIANCE... ...restraints.
Experience with Microsoft Office - Word, PowerPoint, Excel, Access, and...
...perform EHS tasks to ensure Regeneron's compliance with Environmental Health and Safety regulatory requirements, policies and procedures as directed by EHS Department Management or Site Lead.
In this role a typical day might include, but is not limited to, the following:...
...lifecycle of documents.
Contact external vendors to come on site, organize induction, organize safe permit for work and supervise... ...as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
Equipment SME with respect...
...Investigations practices to foster compliance and meet different regulatory expectations
Participating in regulatory inspections as... ...Compliance representation and participation in cross functional site meetings
Technical writing assignments such as SOPs, protocols...
...advice and direction to other company departments on quality and regulatory issues
Acts as an auditor on behalf of Regeneron Ireland... ...of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately...
...Ensuring that all work carried out is in compliance with the required regulatory standards, conforming to company policies and standard operating... ...and completing CAPAs and Change Controls in accordance with site procedures
Writing new and updates current SOPs as needed...
...responsible for promoting the use of statistical thinking across the site departments to support validation, trending, and advancement of... ...technical reports and memos, and engaging directly with regulatory agencies
Operating with a high degree of autonomy within a team...
...Compiling, reviewing and approving documentation
Driving continuous improvement initiatives/programs
May support the site through regulatory audits by providing technical expertise
Assigning training to team members and ensure its completion in a timely manner...
...accurately and in compliance with cGMP procedures, established regulatory requirements, SOPs, and other approved test methods
Supervising... ...are initiated and completed on time and in accordance with site procedures
Training, developing and mentoring direct reports...
...Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends.
Accountable for the proper... ...analysis and operations.
Strong background and familiar with site change control, risk management and data integrity initiatives/programs...
...aspects of calibration of instruments & equipment across entire site, including compliance and management of contracts and projects.... ...subject matter expert and presenting related topics & details to regulatory inspectors during inspections
Responsible for all aspects of...
...with department goals
Partnering with counterparts from sister sites to ensure global alignment of processes, systems and procedures,... ...with counterpart site leads
Interfacing directly with regulatory or partner inspectors, as needed, to represent documentation system...
...compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified... ...problems
Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory trends...
...priorities electronic laboratory data systems projects to maintain harmonization and electronic data integrity across IOPS sites and compliance with regulatory guidelines.
As a QC Electronic Data Management Specialist, a typical day might include, but is not limited to, the...
...implementation of robust corrective actions for supporting manufacturing and site operations. Providing compliance expertise throughout the... ...on investigation processes and techniques
May assist in regulatory inspection preparations, act as a department liaison during...
...ensuring that the IOPS IT group is operating in compliance with Regulatory requirements and Regeneron internal procedures as well being the... ...Data Integrity for all IT systems
Represents IOPS IT at various site/cross-site meetings
Ensures IOPS IT procedures follow...
...standards and reporting any quality anomalies.
Complying with all regulatory agency requirements.
Knowledge, Skills and Abilities:
You... ...in a dynamic environment with cross functional teams.
Our site operates on a 24/7 basis and we offer a number of different...
...Our client, A leading laboratory in Limerick, are seeking a Senior Regulatory Officer to join their team. This role will provide ongoing support to the regulatory team and to all teams with regulatory and legal requirements.
Please Note: This is a six month fixed term...
...ensuring safe working environment
Assuring compliance with all regulatory requirements as related to equipment maintenance functions... ...an up-to-date training file to ensure compliance
Adhering to site standards & programs (e.g. SCC (Site safety, cleanliness, compliance...
...Operations function. This role will be part of the QA Operations site management team and is a key leader in the cross functional... ...pharmaceutical industry around the world
Involving in aspects of Regulatory Agency interactions and preparation as related to site inspections...
...background in hospitality management with extensive F&B or Front Office managerial experience in particular. You will inspire your team to... ...healthy with our Bike to work scheme
Xmas savings club
On site parking
Uniform provided.
Great National South Court Hotel...
...accordance with Standard Operating Procedures (SOPs), cGMP's and regulatory requirements.
As a Facilities Cleanroom & HEPA Certification... ...an up-to-date training file to ensure compliance
Adhering to site standards & programmes (e.g. SCC (Site safety, cleanliness, compliance...
...oversite of the QA Microbiology and Lab Support Teams at the Raheen site. This person is the leader for these two organizations and must... ..., safe, and effective products that are compliant with global regulatory expectations with respect to microbiological and quality control...
...HVAC/Refrigeration personnel and to insure compliance with all regulatory codes
Supporting continuous improvement, 5S and Lean Initiatives... .../troubleshooting on server related issues
Complying with site safety policies and strive to maintain an accident-free environment...
...statement made under Article 12(1) of the Children First Act 2015. The office is also responsible for appropriately supporting relevant... ...achieve compliance under section 12 (1) – (5) of the legislation.
Regulatory Practice Development: The Regulatory Practice Development Team...
...The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory... ...and the Cook International local office and/or Cook distribution partner.
Coordinates... ...nutrition talks
~ Fully equipped gym on site
~39-hour week with flexible start &...
...clients using leading technology and exceptional service.
This is an exciting opportunity within the recently-established Regulatory Risk & Oversight Office in Asset Servicing.
The Regulatory Risk & Oversight Office oversees the management of regulatory risk across Asset...