QA Specialist

Why Patients Need You

Everything we do every day is in line with an unwavering commitment 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 team. You will evaluate and review Pfizers clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards in the manufacturing and packaging of the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a QA Specialist your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Job Responsibilities:

• Support operations through real time batch review ensuring all batch manufacturing records (paper / electronic) and associated manufacturing deviations are reviewed in a timely manner and in accordance with release schedules.
• Support issue resolution incident routing and deviations
• Complete walkthrough audits to ensure the area is maintaining cGMP compliance standards.
• Attend IMEx meetings and ensure timely escalation of issues to the QA Manager
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Review and approval of validation documents Process cleaning & method validation.
• Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filings.
• Ensure that production instructional documentation (SOPs and batch records) are up to date compliant and supports RFT (right first time) production and that all in -process control limits and specifications have been met.
• Review all operational SOPs forms protocols and reports and any related documentation as applicable.
• Ensure all batch deviations are reported in accordance with Pfizer corporate standards.
• Provide input and support to manufacturing operations teams in the investigation of manufacturing deviations and resolution of discrepancies.
• Conduct cGMP compliance area walk-throughs of Manufacturing Operations as required.
• Ensure all manufacturing related CAPAs are implemented in a timely manner and are effective in support of RFT principles.
• Review and approve all manufacturing related change controls and ensure all changes are reported in accordance with the Pfizer corporate standards.
• Provide support to the investigation of product complaints as required.
• Assist in the creation and maintenance of up to date QA policies SOPs and reports.
• Assist in the development of training curricula and records for the QA Operations Group.
• Provide training on Quality Assurance SOPs as required.
• Participate in cross-functional teams as required.
• Provide consultative support on quality related topics to Manufacturing Operations.
• Participate in the internal audit programme as required.
• Support the introduction of new products including validation campaigns and tech transfer projects.
• Support and Lead Continuous Improvement projects
• Support the wider QA team in ensuring quality and compliance metrics are maintained and monitored
• Contribute to the completion of projects manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Suggest improvements and conduct continuous improvement activities.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices part of GxP practices.
• Perform and assist with additional duties as may be directed by the QA Manager or QA Ops Lead.

The Shift QA Operations Specialist role is a 24/7 shift based role within the QA Team and provides support to the Manufacturing Operations team

Qualifications

Must-Have

• Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
• Minimum 2 years experience as detailed above in the job responsibilities section within a QA/QC GMP environment in a Pharma/Biotech company.
• Excellent communication and interpersonal skills.
• An ability to work independently as well as a member of a team in a dynamic fast-paced environment.
• Proactive approach and strong critical thinking skills

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