QA Stability Specialist

Job Description

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 Pfizers 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 support and maintain the stability programs conducted by the stability group and designed to meet 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 set 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 GSOP 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 SME input on quality issues and investigations for out of specification or questionable investigations
• Author review and approve stability sections in regulatory filings.
• Supports the introduction of new products and other life changing medicines
• 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 Protocols Reports and Specification document as required
• Participate in site self-inspections internal audits board of health audits and third party audits.
• Trend reviews and Site Quality Review Team (SQRT) when required

Qualifications

Must-Have

• Bachelors Degree
• 4 years experience within a QC/QA environment ideally with experience of stability testing.
• Proactive approach effective time management strong critical thinking and organisational skills
• Must be able to work in a team environment within own team and interdepartmental teams
• LIMS PDOCs QTS and eQMS experience
• Working knowledge of ICH Stability Guidelines
• Excellent communication and social skills
• Basic knowledge of statistical methods

Nice-to-Have

• Masters 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 task at regardless of circumstances and stress induced pressure

All applicants must have relevant authorisation to live and work in Ireland.