QA Specialist, Pfizer

at  Pfizer

Investigate, document Quality Assur
Job Purpose: To ensure that Drug Substance is manufactured and tested to cGMP requirements in the Grange Castle facility and to support the review and disposition of batches.

Job Responsibilities:

• Prepare batch disposition files for QP approval/disposition including recommendation of batch disposition decisions.
• Review all batch manufacturing records (paper / electronic) and associated manufacturing deviations in a timely manner and in accordance with release schedules.
• 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.
• Perform and assist with additional duties as may be directed by the QA Ops Lead or QA Senior Manager.
• Education/Experience
• Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
• Previous relevant Quality 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.

Work Location Assignment: Flexible

Additional Information

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
• Please note there is no relocation support available for this position

How to apply

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

Purpose
Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Quality Assurance and Control

• Prepare batch disposition files for QP approval/disposition including recommendation of batch disposition decisions.
• Review all batch manufacturing records (paper / electronic) and associated manufacturing deviations in a timely manner and in accordance with release schedules.
• 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.
• Perform and assist with additional duties as may be directed by the QA Ops Lead or QA Senior Manager.
• Education/Experience
• Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
• Previous relevant Quality 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