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You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s 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 products. In 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.
Job Responsibility:
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 SOP’s, 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, SOP’s and reports
Assist in the development of training curricula and records for the QA Operations Group
Provide training on Quality Assurance SOP’s 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
Requirements:
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:
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 task at regardless of circumstances and stress induced pressure