▷ Urgent Search QA Stability Specialist
5 hours ago
Cpl in partnership with our client Pfizer are seeking a QA Stability Specialist to join the team at their state of the art plant in Dublin, Grange Castle for an 11 month fixed term contingent contract. This is a hybrid working role.
Why Patients Need You
Everything we do, every day, is in line with an unwavering dedication to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance stability team.
As a Stability Specialist, your knowledge and skills will contribute towards the goals and objectives of the team. This role will be to provide the appropriate management and technical expertise in order to maintain the stability programs conducted by the stability group and designed to assist new and existing product licensing requirements.
This role requires a close working relationship with Quality Control, Manufacturing, Regulatory Affairs and Development Groups.
How You Will Achieve It
• Contribute to the completion of projects, manage own time to meet targets and develop plans for work activities on own projects within a team.
• Suggest improvements and conduct continuous improvement activities.
• Provide technical expertise in the design, implementation and management of stability studies, including relevant documentation, in line with current regulations, PQS and business needs. All related procedures and documentation are to be maintained accordingly.
• Facilitate creating and maintaining the schedule for completion of the Annual Stability Program
• Participate in cross functional teams as required to provide support on quality issues and provide support with investigations for out of specification or questionable investigations
• Key role in participating in the Stability Review Board (SRB) process
• Author, review and approve stability sections in regulatory filings.
• Supports the introduction of new products
• Update and create APQRs as required
• Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards
• Review and update SOPs as required
• Support and participate in site self-inspections, internal audits, board of health audits and third party audits.
• Trend reviews and Site Quality Review Team (SQRT) whenrequired
Qualifications
• Bachelor's Degree
• 2+ years' experience within a QC/QA environment, ideally with experience of stability testing. Graduates will also be considered.
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
Nice-to-Have
• Master's degree and relevant pharmaceutical experience
• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
• Effectively manages stressful situations, able to focus on tasks regardless of circumstances and stress induced pressure
• LIMS experience
• Working knowledge of ICH Stability Guidelines
• Excellent communication and interpersonal skills
• Basic knowledge of statistical methods
#J-18808-Ljbffr
-
[Urgent Search] Contract Manager
6 hours ago
Dublin, Ireland Design Build Search Full timeDesign Build Search are working with a leading mechanical engineering contractor operating across Ireland. They are currently recruiting for a Contracts Manager to join our team and provide leadership and direction on all projects managed. Responsibilities: Responsible for driving operations and budget through successful leadership, organisation plans,...
-
QA Specialist
7 days ago
Dublin, Ireland FRS Recruitment Full timeJoin a Market-Leading Dairy Production Company as a QA Specialist! About The Company: Are you ready to bring your skills to a company with over 35 years of expertise? My client is a leading Dublin-based dairy production company, supplying premium Irish and Continental dairy products to the Catering and Retail sectors. Located just 10km south of Dublin City...
-
Tax Assistant Manager
6 hours ago
Dublin, Ireland Verde Search Full timeRole| Tax Assistant Manager Company| Highly respected specialist Irish Tax firm Size| 45 staff in Dublin (and growing) Areas| High profile business leaders, HNWI and their associated companies Based| Dublin 4 Hybrid| 2-3 days a week in-office Offer| €60k - €70k base salary + Bonus (up to 10%) + Salary review in 6 months ---- Verde Search are partnering...
-
QA Specialist New
5 hours ago
Dublin, Ireland CPL Full timeCpl in partnership with our client Pfizer are seeking QA Specialist to join the team for an 11 month fixed term contract in their state of the art site in Dublin, Grange Castle. Depending on shift working, this is an onsite role. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will...
-
QA Compliance Specialist
5 days ago
Dublin, Ireland Headcount Solutions Limited Full timeSnr Specialist, QA Compliance Materials ManagementAn opportunity for has arisen to recruit a QA Compliance Snr Specialist within the Materials Management team of a Dublin based Biotech multinationalThe successful candidate will support the material qualification and release activities for the new commercial drug product manufacturing facility for its...
-
QA System and Validation Specialist
7 days ago
Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
-
QA System and Validation Specialist
6 hours ago
Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
-
QA Specialist
7 days ago
Dublin, Ireland PE Global Full timeThe Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...
-
[Apply in 3 Minutes] QA Specialist
5 hours ago
Dublin, Ireland FRS Recruitment Full timeJoin a Market-Leading Dairy Production Company as a QA Specialist! About The Company: Are you ready to bring your skills to a company with over 35 years of expertise? My client is a leading Dublin-based dairy production company, supplying premium Irish and Continental dairy products to the Catering and Retail sectors. Located just 10km south of Dublin...
-
3 Days Left: QA Specialist
5 hours ago
Dublin, Ireland FRS Recruitment Full timeAbout The Company: In operation for over 40 years this company have been the go-to supplier for authentic Asian ingredients and products in Ireland. As one of the country’s largest providers of fresh, frozen, dried, and canned goods, they serve restaurants, caterers, and retail customers with everything they need to create amazing Asian dishes. The...
-
Audit Manager
6 hours ago
Dublin, Ireland Verde Search Full timeRole | Audit Manager Company | Globally recognised Accounting Firm Size | 300 across Ireland, 200+ in Dublin Focus| Leisure / Tech / Retail / Manufacturing sectors Tech | CaseWare Based | South Central Dublin Hybrid | 2-3 days a week in-office Offer | Attractive base salary + Bonus + Pension + Health + Partner Path Verde Search are partnering with a growing...
-
▷ Immediate Start! QA Officer
6 hours ago
Dublin, Ireland Quorum Search Partners Full timeLocation:Dublin. Contract:Full-Time, Permanent. Reporting to: Technical and Quality Group Manager. Shift Pattern: 4 days on and 4 days off - 12 Noon to Midnight. Salary: Negotiable, depending on experience. Benefits:Pension Contribution Scheme, Long Term Illness Benefit, DIS. About the Role:Join the dynamic team of a Leading Irish Food Business as a QA...
-
Senior QA Validation Specialist
7 days ago
Dublin, Ireland PE Global Full timeDescription: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new...
-
Senior QA Specialist
6 days ago
Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Senior Quality Assurance Specialist (Validation) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7 years of experience working in the pharmaceutical or biotechnology industry and are ready for...
-
Dublin, Ireland GKR Search & Selection Full timeAircraft Leasing Technical Analyst - Dublin, Ireland My client is a major aircraft leasing firm which is recruiting for a Technical Analyst with aircraft leasing experience. Reporting directly to the CTO, this is a great opportunity to join a high-profile lessor. Responsibilities: Develop tools for forecasting maintenance events and cash flows. Create...
-
▷ [Urgent Search] Fit-out Project Manager
6 hours ago
Dublin, Ireland Construction Specialist Recruitment Full timeFit-out Project Manager Our award winning client have over 20 years of experience in the Irish market are hiring for a Fit-Out Project Manager to join their team in Dublin. This company has a Strong pipleine of work and are actively recruiting for an experienced project manager for a range of projects including retail hospitality and office fit-outs....
-
Urgent Search: Finishing Foreman
6 hours ago
Dublin, Ireland Construction Specialist Recruitment Full timeFinishing Foreman North Dublin The CSR Group is looking to recruit an experienced Finishing Foreman for a Large Residential Project in North Dublin. This Project is well underway and looking for someone with a keen eye and good work ethic to join a great company who are market leaders in the industry. Mainly consisting of apartments this project has a total...
-
QA Lead Engineer Fast-Scaling Organisation!
7 days ago
Dublin, Ireland Archer Recruitment Full timeQA Lead Engineer Fast-Scaling Organisation! ?? Shape the Future of QA ?? Lead in a Fast-Growing Environment ?? Work Alongside the Best in the Business Step into a career-defining role as a QA Lead Engineer with one of the worlds most dynamic and rapidly scaling organizations. This is your chance to join a team known for hiring the best and develop your...
-
Urgent care nurse
5 hours ago
Dublin, Ireland VHI Health and Wellbeing DAC Full timeRole Title: VHI 360 Urgent Care Nurse Role Location: Swords A 6 month, fixed term (part time 20 hours per week) contract vacancy has arisen for the role of an Urgent Care Nurse. The successful candidate will be part of the multidisciplinary team (MDT) and will provide specialist nursing care to patients presenting with a range of urgent care and minor...
-
▷ [Immediate Start] Clinical Support Specialist
5 hours ago
Dublin, Ireland Independent Search Solutions Full timeAt Independent Search Solutions Ltd we currently have a position for an Orthopaedic Clinical Support Specialist to cover the Dublin / Leinster Territory. We need you to be based in Dublin or within commuting distance as this position will mainly see you meeting with and dealing with the Orthopaedic Surgeons in both the Private and Public Hospitals in the...