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
