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
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