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QAV/CSV Consultant
Tandem Project Management Ltd.
Overseeing validation activities in a biopharmaceutical company, ensuring compliance with regulatory requirements and cGMP.
22d ago
€120,000
Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Dundalk, County Louth, Ireland
Onsite
Company Size
50 Employees
Service Specialisms
Project Management
Construction Services
Consulting
Property Development
Engineering
Design
Turnkey
Sector Specialisms
Life Sciences
Commercial
Industrial
High Tech
Public
Role
What you would be doing
qa validation
regulatory support
sop review
document approval
oversight management
team management
- Coordinate all QA validation activities to ensure schedule adherence and on-time delivery of project deliverables.
- Provision of support during regulatory inspections and client audits.
- Review SOPs relating to qualification and validation activities.
- Ensure that all validation documentation and associated data, including but not limited to plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications, and other applicable acceptance criteria.
- Ensure that all events or deviations, investigations, and change evaluations that occur during qualification or validation activities have appropriate QA oversight, QA review and approval, and adhere to SOPs and cGMP requirements.
- Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerised systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes.
- Provision of QA validations expertise to maintain the validation status of the facility.
- Manage and develop the QA validations team, including, but not limited to, performance management, recruitment, and training.
- Ensure quality oversight of qualification and validation activities for all facilities, utilities, equipment, computerised systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units, CTUs, and shipping processes.
What you bring
validation
gamp
fda
root cause
problem solving
degree
- Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
- Knowledge of GxP regulations applicable to biologics manufacturing, for example, EU GMP, FDA, ISO, and the industry standards applicable to validation, including but not limited to GAMP, ISPE, ISO, ASME, and BPE.
- Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams and FMEA
- Knowledge of troubleshooting and problem-solving skills.
- Experience in a Quality Engineering, Quality Assurance, or Quality Validations role for biologics or related pharmaceutical or medical device manufacturing in an FDA and EU-regulated environment.
- B.Sc. or B.Eng. in a scientific or engineering-related discipline, for example, biochemistry, chemistry, or engineering.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- regulatory inspections and client audits
Company
Overview
- Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries.
- The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget.
- Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects.
- Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements.
- Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value.
- The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle.
- With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.
2017
Continuous Professional Development
The company has been accredited by Engineers Ireland for CPD since 2017, demonstrating a commitment to ongoing professional development and standards.
Repeat Business
Client Loyalty Track Record
The company maintains a strong track record of repeat business, reflecting its ability to consistently deliver exceptional results and build lasting partnerships.
- Safety and quality are at the heart of everything that we do.
- Openness, transparency and collaboration.
- Client‑centred, collaborative approach.
- Tailored approach to meet client needs.
- Driven by senior team who lead by example in professionalism and commitment.
- Lean techniques and value management methods to ensure fit‑for‑purpose outcomes and best value for money.
42% Reduction
Commitment to GHG Emissions
Targeting a significant reduction in greenhouse gas emissions as part of a science-based approach.
- Committed to 42% reduction in Greenhouse Gas emissions by 2030
- Established Carbon Action Team to measure, monitor and report GHG emissions annually to the Carbon Disclosure Project
- Initiatives include purchasing renewable energy, sourcing sustainably produced goods and services, monitoring and reducing waste
- Reducing paper usage, switching to electric company vehicles, ensuring efficient office utilities, seasonally adjusting temperature controls
Rating: 4.1/5
Equality, Diversity, and Inclusion
Based on Glassdoor reviews, the company has a strong rating for its commitment to Equality, Diversity, and Inclusion.
Rating: 3.8/5
Culture and Values
Glassdoor reviews highlight the company's overall Culture and Values, reflecting employee sentiment on workplace environment.
- Glassdoor reports ‘collaboration, respect, training, teamwork, autonomous working’ as pros
- Glassdoor reports ‘management are friendly and respectful’
- No public gender-split or DEI quantitative stats published
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