Qualified Person
2 weeks ago
Summary: A biopharmaceutical company in Athlone requires a Qualified Person. The incumbent will be responsible to ensure that licensed finished products, including drug substances and drug products, are certified and released to market in accordance with current requirements. Responsibilities: Ensure that licensed Finished Product to include Drug Substance, Drug Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16. Ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001/20/EC and in accordance with the requirements of Annex 16 and Annex 13. QP release of products across the across the network and contract manufacturing operations to ensure commercial and clinical drug substance, drug product and finished products are certified in accordance with GMP and MA/IMPD to support patient supply for rare diseases. QP Partner with Finished Product Operations team for on time release. Ensure independence of the QP on decisions on quality related matters. Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements. Provide quality and compliance guidance on all critical and major quality matters managed. Perform QP quality review and approval for Annual Product Quality Review. Provide Quality oversight, input into quality documents e.g. QAGs, customer complaints as required. Creates an environment for 'right first time' in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective Support Regulatory Inspections and be a representative of the company in front of Health Authorities and Regulatory Bodies Provide audit support as required for internal auditing program and supplier audits. Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates. Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice. Qualifications & Experience: Preference given to candidates with advanced degrees; eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education. Minimum 8 - 10 years GMP related experience in biopharmaceutical / pharmaceuticals. Eligible and demonstrated ability to act as Qualified Person within EC/EEA. Minimum 2 years QP experience preferable. Extensive demonstrated pharmaceutical quality experience. Must have thorough knowledge of biopharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements. Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance. Skills: EC EEA GMP GDP regulatory compliance
-
Part-Qualified Accountant
3 weeks ago
Mullingar, Ireland The Panel Group Full timeJob Specification Title: Part-Qualified Accountant My client, an award winning FMCG company is looking for an experienced part-qualified accountant to join their growing team based in Westmeath. The successful candidate will be tech savvy, hardworking and have a hands-on approach. Please note this role is office based. The Job: Prepare monthly accounts: P&L,...
-
Experienced Fully Qualified Motor Mechanic
3 weeks ago
Mullingar, Ireland Hamill Rentals Ltd Full timeHamills Motoring services are looking to recruit an experienced fully qualified motor mechanic. Ideal candidate will be self motivated and capable of working on own initiative in a fast paced workshop on a wide range of vehicles. Candidates must have the ability to quickly and effectively carry out fault diagnosis, service and repairs on a wide range of...
-
Tax Senior Manager | SME | Dublin North
6 days ago
Mullingar, Ireland Clarity Search Partners Full timeThe client – Our client, a progressive and well-established SME firm based in North Dublin, currently requires an AITI Qualified Manager or Senior Manager to join the team on a full-time basis. The position will require the successful candidate to work on a portfolio of clients from SME enterprises, high net worth, and large corporate clients. The firm...
-
Mullingar, Ireland Accountancy & Business Personnel Ltd. Full time- Permanent - Reference: 24417-SF The Company Our client is a well-known organization seeking to appoint a financial reporting accountant. The Position: This role will be responsible for the coordination of the financial reporting requirements of the division, dealing with auditors and focusing on internal and external reporting. The role will also...
-
Mullingar, Ireland Clarity Search Partners Full timeThe Opportunity We have an opportunity for an Audit Senior to join our team in Dublin. This is a fantastic opportunity for someone to develop and grow their career within a friendly and supportive environment, whilst gaining exposure to a broad range of clients. Who we are We work with a wide variety of clients across multiple industries and really get to...
-
Corporate/Banking Solicitor
6 days ago
Mullingar, Ireland Hunter Savage Full timeCorporate/Banking Solicitor Description: We are hiring on behalf of our client, a growing law firm based in Dublin, for a Corporate/Banking Solicitor (NQ+) to join their dynamic team. This is an excellent opportunity for a solicitor eager to work with high-profile clients in a fast-paced and collaborative environment. Top 3 Things to Know About this...
-
Utilities Project Manager
2 weeks ago
Mullingar, Ireland HRM Recruitment Limited Full timeA leading innovative pharmaceutical organisation are investing into their new Irish facility. The company is a global leader in the therapeutic areas of haemophilia disorders and diabetes. This is an established site so a full program of transformation is underway to complete a retrofit alongside a number of upgrades across the campus. The business is...
-
▷ [High Salary] Healthcare Solicitor
2 weeks ago
Mullingar, Ireland Hunter Savage Full timeJob Title: Healthcare Solicitor Location:Dublin, Ireland Company:Leading Irish Commercial Law Firm Position Overview: We are seeking a highly skilled and motivated Healthcare Solicitor to join this prestigious, leading law firm in Dublin. As a key member of the team, you will have the opportunity to work on complex cases, advising public bodies,...
-
Project Accountant, Public Sector, Kildare
2 weeks ago
Mullingar, Ireland Accountancy & Business Personnel Ltd. Full timeProject Accountant, Public Sector, Kildare - Contract Our client, a Public Sector body based in Kildare, is currently looking to recruit an experienced Accountant to join their team reporting to a Financial Controller. Duties & Responsibilities - Maintain financial accounting systems and records - Prepare monthly Accounts and Annual Financial...
-
▷ [1/24/2025 A] Retail Assistant ROI
2 weeks ago
Mullingar, Ireland Screwfix Direct Ltd Full timeYou’ll be at the core of Screwfix, making sure our customers are the heart of everything we do. You’ll take your time to really get to know them whilst delivering genuinely great service. Our Retail Assistants are vital to the running of a store, so you’ll always be kept busy. And with the help of our excellent training programmes and varied shift...
-
Mullingar, Ireland OASIS Group Full timeSpeech and Language Therapist Senior Grade - Dunshaughlin, County Meath, Ireland - Full time, Permanent Who We Are Enable Ireland provides services to over 13,000 children and adults with disabilities and their families from 43 locations in 14 counties. Covering childhood to adulthood our expert teams work with the individual and their family on a plan...
-
Mullingar, Ireland Keurig Dr Pepper Full timeJob Overview: KDP Ireland has an opportunity for a Document Control Specialist to join our Quality team on a contract basis. This role will support our Quality team during a transition period and manage supplier documentation. This will be a global based role working with teams in Ireland and the US. This is a six-month contract position. What you will...
