Find Regulatory affairs manage Jobs

GMP and GDP Lead
FQS Pharma —Remote
- Full-time
- Remote
- Manufacturing
- Communication skills
- Flexitime
- Work from home
Quick apply
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Pharma Quality & Regulatory Officer
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Quick apply
9d
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10d
CMC Biopharma Regulatory Consultant — Ecolab Life Sciences
Ecolab Inc. —Dublin, County Dublin
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CMC Biopharma Regulatory Consultant — Ecolab Life Sciences
Ecolab —Dublin, County Dublin
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4d
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Director, Regulatory Affairs Medical Devices & Combination Product
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Senior Specialist Regulatory Key Initiatives
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Labeling Specification Specialist
Medtronic —Galway, County Galway
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Director Regulatory Affairs Global CMC
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Teleflex —Athlone, County Westmeath
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Head of Programme Management Office (PMO) – Fixed Term Contract- Assistant Principal
Coimisiún na Meán —Dublin, County Dublin
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Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence
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GMP and GDP Lead

FQS Pharma
Remote

Quick apply

Job details

Full-time
8 days ago

Benefits

Bike to work scheme
Flexitime
Work from home
On-site parking

Qualifications

Manufacturing
Communication skills

Full job description

Overview:

FQS is a successful Pharmaceutical Consulting Firm serving leading national and international clients in Ireland, UK and beyond since 2005.

We are seeking enthusiastic and driven individual to join our team. You will have the responsibility for leading a client project.

The candidate will be highly professional, self-motivated, have excellent communication and problem-solving skills, and have the ability to effectively manage stakeholders. You will be part of a high-performance team and will have the opportunity to excel and grow your career delivering quality at a fast pace.

You will be responsible for delivering GMP compliance, supplier assurance and product quality oversight activities on behalf of our client. The role ensures that products manufactured, tested, released and distributed through third-party partners are managed in accordance with applicable GMP requirements, Marketing Authorisation Holder obligations and company quality standards.

Experience in GMP environment is essential.

Key Accountabilities

Lead GMP compliance and Marketing Authorisation Holder (MAH) quality oversight, ensuring products are manufactured, tested, released and distributed in accordance with regulatory requirements and company quality standards.
Provide quality oversight of contract manufacturers, laboratories and other GMP/GDP service providers through supplier qualification, audits and ongoing performance monitoring.
Establish, maintain and review Quality Technical Agreements (QTAs), ensuring quality responsibilities are clearly defined across the supply chain.
Lead Product Quality Reviews (PQRs), Stability Programmes and validation oversight to support continued product quality and regulatory compliance.
Maintain oversight of GMP quality documentation and quality systems, including deviations, investigations, CAPAs, change controls and associated quality records.
Support regulatory inspections, customer audits and Regulatory Affairs activities by maintaining inspection readiness and providing quality documentation and compliance support.
Monitor quality performance through KPIs and quality metrics, identifying risks and driving continuous improvement initiatives.
Provide Quality support for new product introductions, technical transfers, acquisitions and other strategic business projects.

Experience

Proven experience in a document control or QA role preferably within the pharma/medical device in wholesale, manufacturing, or related industry
Minimum of 4+ years' experience within a pharmaceutical manufacturing environment.
Working knowledge of Pharmaceutical EU and US regulatory requirements
Lead auditor desirable but not essential
Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC).
Excellent PC skills and administration skills (OFFICE)
QP desirable but not essential

Skills

Highly Self-Motivated
Good Attention to detail
Ability to work as part of a team and meet targets/goals efficiently.
Must be reliable and well organised with excellent oral and written skills.
Experiencing supervising and managing projects.
Good teamwork and strong issue resolution and communication skills across functions and organisations.
An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.
Flexibility to learn new skills and take on new tasks and responsibilities.
The ability to work independently on complex tasks.

Contract length: 11 Months

This role offers flexibility and would suit candidates seeking a 3, 4 or 5-day working week.

Salary: €TBC - Salary is negotiable and based on qualifications and experience.

Benefits:

Flexible working environment
Hybrid & Remote Working
Flexitime
On-site parking
Work from home
Health Scheme
Pension
Cycle to Work Scheme
Upskilling and training available and encouraged
Potential to grow and develop your career

Job Type: Full-time

Benefits:

Bike to work scheme
Flexitime
On-site parking
Work from home

Experience:

pharmaceutical manufacturing or wholesale / pharmacist: 2 years (preferred)

Work Location: Remote

Quick apply

Refine Your Search

regulatory affairs manage jobs

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