Quality Assurance Specialist
3 days ago
- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 4-5 years
- City: Carlow
- State/Province: Carlow
- Country: Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients’ expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
An amazing opportunity for a Quality Assurance Specialist to join our quality team. In this role, you will play a vital role in supporting the introduction of new products and quality oversight of executed validation completed.
As the QA Specialist for Validation and New Product Introduction (NPI), you will be an essential member of our esteemed Technical Transfer/Validation Team. This team holds responsibility for managing the development and manufacture of vaccines and biological products. Alongside your day-to-day QA activities, your main focuses will be reviewing and approving all validation documents relating to a sterile facility including cleaning validation, ensuring to support corporate compliance and regulatory expectations for manufacturing.
You will report to the Associate Director of Quality and collaborate closely with cross-functional teams on-site, particularly Technical Engineering. Your key objective will be to ensure that manufacturing, technical, and regulatory requirements are met.
Requirements
Responsibilities:
- Provide quality oversight and direction for the introduction of new products.
- Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
- Participate as a functional expert in the cross-functional team responsible for introducing products.
- Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
- Review documentation associated with new products, such as QC Test Specifications, BOMs, and MES documentation.
- Support deviation close out in a timely manner.
- Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.
Skills & Education Required:
- A Bachelor's degree or higher in a related Science discipline is preferred.
- A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
- Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
- Strong report, standards, and policy writing skills.
- Experience with equipment and process validation.
- Familiarity with sterile filling processes and equipment.
- Proficiency in Microsoft Office and job-related computer applications.
- Experience or familiarity with Lean Six Sigma methodology is desired.
- Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
- Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
- Proven ability to drive the completion of tasks.
- Strong decision-making capability with a sense of accountability and responsibility.
- Demonstrated problem-solving skills.
Reporting To: Associate Director of Quality
#J-18808-Ljbffr
-
Apply Now: Site Manager
3 days ago
Longford, Ireland Construction Specialist Recruitment Full timeJob Title: Site Manager (Pharma Project) Location: County Longford Salary: Competitive, based on experience About the Role A leading Tier 1 Main Contractor is seeking an experienced Site Manager to oversee the construction of an extension to a pharmaceutical project in County Longford. This is an excellent opportunity to join a well-established and respected...
-
Risk & Quality Manager
2 weeks ago
Longford, Ireland REACH INTERNATIONAL INC Full timeRisk & Quality Manager - Dublin, Ireland Dublin, Ireland | Permanent | Excellent Package The Company Reach International is working with this Global Accountancy firm to recruit a Risk & Quality Manager for its Dublin, Ireland office. This role sits with the Risk Management area within the Assurance Group. The Role - Working with engagement teams to help...
-
[Apply in 3 Minutes] Quality Engineer
2 weeks ago
Longford, Ireland INFORM3 Recruitment Full timeJob Title Quality Engineer Job Location Co. Longford Salary -€50K - €60K BOE About the Company: Are you an experienced Quality Engineer? If so then this is the role for you! A leading Manufacturing company based in County Longford are currently looking to add to their well-established team who specialise in solutions for the medical & pharmaceutical...
-
[Only 24h Left] Site Engineer
1 week ago
Longford, Ireland Construction Specialist Recruitment Full timeSite Engineer Hospital Refurbishment & New Build Location: County Longford, Ireland Contract Type: Full-Time, Permanent Salary: Competitive, based on experience Overview: We are currently seeking an experienced Site Engineer to join our team for an exciting hospital refurbishment and new build project in County Longford. This role will involve overseeing the...
-
3 Days Left! Quality Manager
2 weeks ago
Longford, Ireland MATRIX Recruitment Group Full timeMy Client, a leading player in the food manufacturing industry, is seeking an experienced and dedicated Quality Manager to join their team in Longford. In this key role, you will be responsible for leading and overseeing all aspects of food safety and quality management across the organisation, ensuring that quality standards meet regulatory and customer...
-
IT Specialist
2 weeks ago
Longford, Ireland Collins McNicholas Recruitment Full timeOur client, a leading global healthcare company in Longford, is recruiting an IT Specialist on an initial 6 month contract. Requirements: 1. Experience with business management, systems engineering, operations research, and management engineering aspects of the role. 2. Specialization in particular software or business applications utilized in an end user...
-
IT Advisory Manager
2 weeks ago
Longford, Ireland REACH INTERNATIONAL INC Full timeDublin, Ireland | Permanent | Excellent Renumeration Package The Company Reach International is working with this global accountancy firm to appoint an IT Audit Manager to their Dublin office. The ideal applicant would have at least 5 years’ experience within IT audit plus relevant qualifications. The Role 1. Information system audits: assessment of IT...
-
QA Supervisor
2 weeks ago
Longford, Ireland Quorum Search Partners Full timeWe have an exciting opportunity for a QA Supervisor to join a very successful,leading FMCG in Longford. Working Hours: Week 1 6.30am to 3pm and the following week 3pm to 11pm. Negotiable salary depending on experience. Responsibilities: To ensure Quality Management Systems are implemented and maintained in order to guarantee that we produce safe and legal...
-
▷ Urgent: HV Project Manager/Contracts Manager
2 weeks ago
Longford, Ireland ICDS (UK) Ltd Full timeHV Project Manager/ Contracts Manager - €100k -110k Our client is a leading international, specialist engineering and construction company founded over 50 years ago and now operating in the United Kingdom, Ireland, Canada, and America. They are hiring a High Voltage Project Manager to be responsible for overseeing and managing all aspects of electrical...
-
QA Manager
2 weeks ago
Longford, Ireland Matrix Recruitment Group Full timeWhat you need to know: Our client, a leading national company in the manufacturing of bread and bakery products, is currently seeking a QA Manager to join their team in Wexford. This is a full-time, permanent position offering an excellent salary. The role will suit an experienced professional, particularly one with a background and experience in Food Safety...
-
Microbiologist
2 weeks ago
Longford, Ireland Lincoln Recruitment Ltd. Full timeJob Title: Microbiologist We are seeking an experienced Microbiologist with strong management and method development expertise to join a dynamic and growing team in Drogheda, Co. Louth. This is a senior management role offering the opportunity to contribute to an innovative, customer-focused organization. Benefits: - Competitive salary - Bike to work...
-
QA Supervisor
13 hours ago
Longford, Ireland Nomad Foods Inc Full timeOverview The Longford Pizza site is part of the Nomad Foods Group. The business operates two manufacturing sites in Ireland (Longford and Naas) employing approximately 450 FTEs and producing c. 50k tons of Pizzas annually, predominantly under the Goodfella’s and San Marco brands. BEP also produces own label Pizza for many retailers in both the UK and...
-
Longford, Ireland Castore Full timeCastore exists for one single reason – to make athletes better. Our ethos is built upon the philosophy of BETTER NEVER STOPS, an ideal deeply infused in our DNA and something we strive to live every single day. We utilise advanced engineering and unique technical fabrics to create the highest quality sportswear in the world for athletes who demand the very...
-
Site Engineer
1 week ago
Longford, Ireland Global Professional Consultants Full timeSite Engineer A highly reputable main building contractor seeks a Site Engineer with at least 2 years of experience need to on a pharma project in Longford. Our client will likely have 2+ years work for the successful engineer in this location. A Site Engineer with expertise in in a live environment would be ideal for this role. Duties: The candidate must be...
-
Project Process Engineer
2 weeks ago
Longford, Ireland Life Science Recruitment Full timeProject Process Engineer Reference: SMC3795 Location: Carlow Qualification: Degree Experience: See description Job Type: Fixed Term Contract Salary: Not Disclosed We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a...
-
3 Days Left: Project Engineer
2 weeks ago
Longford, Ireland Quanta Consultancy Services Ltd Full timeProject Engineer / Manager - Clean Utilities - Pharma - Carlow, Ireland - 11-Months Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000...
-
Longford, Ireland Teleflex Full timeAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical,...
-
Longford, Ireland Center Parcs UK & Ireland Full timeA range of quality own-brand and high street restaurants and cafés, mixed with great food, family-friendly menus, and a generous sprinkling of excellent service. That’s the recipe for success in our Food and Beverage department. Around each village, the Food and Beverage department employs around 350 team members across multiple different restaurants,...
-
000505 Inspector/Scientific Officer III
2 weeks ago
Longford, Ireland Cpl Healthcare Full timeOur client the Environmental Protection Agency (EPA) are currently accepting applications for the position of Inspector/Scientific Officer III (Level 5) – General. Overview of the Role: The EPA is recruiting to fulfil the role of Inspector/Scientific Officer III (Level 5) General. The appointee will be assigned a technical role reporting to a line...
-
Business Motor Market Facing Underwriter-Hybrid
2 weeks ago
Longford, Ireland Zurich 56 Company Ltd Full timeBusiness Motor Market Facing Underwriter-Hybrid 119584 Business Motor Market Facing Underwriter We are part of the worldwide Zurich Insurance Group, established in 1872 and headquartered in Switzerland. Our 55,000 employees across the globe serve customers in more than 170 countries, from individuals who need their homes, cars or lives insured, to...