Find Pharmaceutical responsible person Jobs in Dublin County Dublin

Quality Manager / Responsible Person (RP) - Full time
Althera —Dublin, County Dublin
- Full-time
- Doctoral degree
- English
- Bachelor's degree
- Sick pay
Quick apply
5d
Authorised Person - Europe
Ross Engineering —Dublin, County Dublin
- €70–€100 an hour
- Full-time
- No degree
- Communication skills
Quick apply
R&D Category Scientist Women's Health
Perrigo —DUBLIN 2, County Dublin
- Hybrid work
- Doctoral degree
- Master's degree
- Bachelor's degree
Microbiology and Sterility Assurance Lead
Baxter —Dublin, County Dublin
- Management
- Clinic
- Continuous improvement
- Annual leave
3d
Premake Ready Operative
CCL Label Ireland —Dublin, County Dublin
- Full-time
- Organisational skills
- Communication skills
- Sick pay
Quick apply
QA Team Lead - Shop Floor & Environmental Monitoring (EM)
Grifols Worldwide Op Ltd —Dublin, County Dublin
- Full-time
- English
- Mentoring
- Manufacturing
Release & QP Team Lead
Perrigo —DUBLIN 2, County Dublin
- Writing skills
- Bachelor's degree
- Manufacturing
IE - Lead Technical Facilities Co-Ordinator
Flexim Group —Dublin, County Dublin
- €45,000 a year
- English
- Supervising experience
- Communication skills
- Employee assistance program
- Sick pay
Director, Regulatory Affairs Medical Devices & Combination Product
Takeda Pharmaceutical —Dublin, County Dublin
- €116,800–€160,600 a year
- Full-time
- English
- Bachelor's degree
- Communication skills
GMDP Quality Assurance Manager
WEP Clinical —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Quality Manager
Crown Roofing & Cladding Ltd —Blanchardstown, County Dublin
- Full-time
- Organisational skills
- Construction experience
- Communication skills
- Wellness program
- Employee assistance program
Quick apply
13d
IE - Lead Technical Facilities Co-Ordinator
Flexim Group SA —Dublin, County Dublin
- €45,000 a year
- English
- Supervising experience
- Communication skills
- Employee assistance program
- Sick pay
Defect Reduction Engineer
Intel —Leixlip, County Kildare
- €59,200–€111,300 a year
- Full-time
- Engineering
- Data analysis skills
- Research
Maintenance/General Operative
Capital Switchgear —Rathcoole, County Dublin
- €16–€22 an hour
- Full-time
- Carpentry
- Microsoft Excel
- Maintenance
- Employee assistance program
Quick apply
10d
Vice President R&D, Rare Disease
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Doctoral degree
- Research
- No degree
21h
Director of Project Management
IPS-Integrated Project Services —DUBLIN 12, County Dublin
- Full-time
- Engineering
- Project management
- Bachelor's degree
Field Service Technician Mechatronic Ireland & UK
Körber AG —Dublin, County Dublin
- English
- No degree
- Mechanical knowledge
Vice President R&D, Rare Disease
AstraZeneca —Dublin, County Dublin
- Doctoral degree
- Research
- No degree
21h
Head of Systems Implementation – Pricing & Market Access (NAVLIN)
EVERSANA —Dublin, County Dublin
- Full-time
- Remote
- Microsoft Powerpoint
- Microsoft Excel
- Master's degree
Quick apply
Senior Manager, Global Device Quality
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook

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Quality Manager / Responsible Person (RP) - Full time

Althera
Dublin, County Dublin

Quick apply

Job details

Permanent | Full-time
5 days ago

Benefits

Bike to work scheme
Company pension
Sick pay
On-site parking

Qualifications

Biology
Doctoral degree
English
Quality management
C
Bachelor's degree
Chemistry

Full job description

Requirements for Quality Manager/RP

This note describes the role and requirements for Quality Manager and is organized in followings sections A. Summary description, B. About Althera, C. Job description, D. Experience and skills requirement. This Job is based in the Dublin site of Althera.

A. Summary Description

Title: Quality Manager/RP

Location: Dublin, Ireland.

Working hours: Full time

Salary: Dependent on experience/Negotiable

Experience expected: 10 to 14 years exclusively in EU GMP compliance

Education required: Graduate degree preferred

B. About Althera Pharmaceuticals

Althera is a Pharmaceutical R&D and commercialization organization with operations in US, Europe and India. The company is headquartered in Ireland. Our mission is to make significant positive impact on lives of patients by bringing to market innovative and complex products through our own development and in partnerships with other innovators. Most employees of the company are scientists with post-graduate or Ph.D. degrees. For more information, please visit us at www.altherapharma.com

Althera offers competitive salary, excellent benefits and an environment conducive to professional development.

C. Job description

The Quality Manager’s key role is to ensure Althera’s products imported and distributed in Europe are manufactured and distributed according to EU regulations. This function maintains quality compliance with Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) and Althera Standard Operating Procedures (SOPs). The quality function also ensures the timely release of incoming product batches into the marketplace for sale, assisting Althera subsidiaries in meeting financial sales targets and ensuring that quality product is available to patients.

The expectations of this role are as follows:

1. Team interactions: Interaction with other members of Althera related to quality, regulatory requirements, batch importation, audits, submissions, strategic decisions and other internal conversations such as:

a. Supporting and maintaining quality and regulatory requirements in EU

b. Reviewing change controls

c. Coordinate and communicate critical input and critical timelines and deliverables to company leadership, development function and other key departments to facilitate batch release, distribution, regulatory submissions, PSUR and post approval variations, etc.

d. Communication of latest quality requirements to various teams

e. Discussions with and guidance to company leadership and product development functions specific to pipeline products/projects as requested

f. Coordination with quality assurance and regulatory affairs teams of Althera’s partners as may be required from time-to-time

g. Coordination with and management of quality assurance consultants as may be hired by the Company

h. Other interactions within company and with vendors for furtherance of company’s interests and strategy

2. Quality Assurance functional responsibilities:

a. Coordinating launch and post-launch shipments

b. Coordinating with the QPs for the timely release of batches

c. Development, periodic review, revision and implementation of SOPs as required in line with EU guidelines

d. Coordination with regulatory agencies and customers for gaining and maintaining relevant authorizations, including hosting inspections and responding to observations

e. Conduct monthly meetings with customers to track the pending activities and timely resolutions

f. Review of change controls, deviations and CAPAs

g. Participate in, and lead, relevant Quality Risk Management Assessments.

h. Monitoring stock transfers and maintaining retained samples according to GMP

i. Review of Annual product reviews and lead Quality Management Review

j. Review of stability reports for compliance with EU registrations

k. Schedule and carry out Internal Audits

l. Implement/review quality agreements with manufacturers, wholesalers and distributors

m. Ensure that bona fides are established for all customers and suppliers of medicinal products

n. Conducting inspections of manufacturers distributors and wholesalers as necessary per GMP/GDP requirements

o. Acting as primary EU quality contact person with Althera partners and also with Althera subsidiaries for internal quality compliance matters

p. Implementing recall procedures if necessary

q. Receive and conduct as required GDP/GMP training for relevant staff

r. Ensure that training plans are implemented and training records are maintained.

s. When required, to fulfil the Company’s requirements with respect to Responsible Person responsibilities for GDP.

a. Support Pharmacovigilance and Regulatory Affairs as directed when required, e.g. compliance activities, co-ordinating documentation requests

D. Experience and skills requirements

Education: Bachelor’s degree required in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Graduate degree preferred.

Knowledge/Skills/Qualifications:

a. Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of quality assurance and regulatory affairs departments.

b. Hands on experience in interacting on EU quality issues.

c. Ability to work cross functionally within the Company and practically apply GMP / GDP and associated legislation

d. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

e. Experience of conducting audits

f. Ability to assess quality risks, and where appropriate, recommend contingency plans and strategies to mitigate risks.

g. Detail oriented and highly organized.

h. Previous status of Responsible Person in accordance with the HPRA’s educational requirements, experience, training and licensing (compliance with the requirements of Directive 2013/C 343/01) is desired.

Job Types: Full-time, Contract, Permanent

Benefits:

Bike to work scheme
Company pension
On-site parking
Sick pay

Ability to commute/relocate:

Dublin, County Dublin: reliably commute or plan to relocate before starting work (required)

Application question(s):

List three reasons why you would be a suitable candidate for this role?

Experience:

Quality management: 10 years (required)
GMP: 10 years (required)

Language:

English (required)

Work authorisation:

Ireland (required)

Location:

Dublin, County Dublin (preferred)

Work Location: In person

Quick apply

Refine Your Search

pharmaceutical responsible person jobs in dublin county dublin

Quality Manager / Responsible Person (RP) - Full time

Authorised Person - Europe

R&D Category Scientist Women's Health

Microbiology and Sterility Assurance Lead

Premake Ready Operative

QA Team Lead - Shop Floor & Environmental Monitoring (EM)

Release & QP Team Lead

IE - Lead Technical Facilities Co-Ordinator

Director, Regulatory Affairs Medical Devices & Combination Product

GMDP Quality Assurance Manager

Quality Manager

IE - Lead Technical Facilities Co-Ordinator

Defect Reduction Engineer

Maintenance/General Operative

Vice President R&D, Rare Disease

Director of Project Management

Field Service Technician Mechatronic Ireland & UK

Vice President R&D, Rare Disease

Head of Systems Implementation – Pricing & Market Access (NAVLIN)

Senior Manager, Global Device Quality

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