Why patients need you:
Our core principle and commitment towards the patients “Patients lives depend on us” is based on the innovative, quality and compliance. The role you play directly have impact on the patients.
What you will achieve:
You will be member of manufacturing compliance team and will be handling the responses to observations (Internal & External) and driving the inspection readiness program.
You will get a chance to be part of the projects or handle the small projects independently.
It is your hard work and consistent performance that will make Pfizer proud to achieve new targets, help patients and readiness for on-time inspections.
How will you achieve it:
Preparation of response to audit observations, propose CAPAs and take agreement between SME & Quality Assurance for identified items.
Preparation of Quality Risk Assessment (QRM) for the equipment & process and tracking the implementation of mitigation plan.
Responsible for the CCF initiation, coordination with CFTs for impact assessment and CCF pre-approval, implementation and closure.
Responsible to perform the gap assessment PQS/ CAS/ RONA & Others and propose the mitigation/ implementation of actions against the observed gaps.
Track and monitor the detailed milestones of the actions (CAPA/ CCFs) till closure of the actions.
Responsible to perform the walkthrough in the manufacturing area and propose the process improvement actions.
Driving a culture of continuous Inspection readiness
Ensuring all departments in manufacturing maintain compliant, audit-ready documentation
Conducting readiness assessments, mock audits, and gap analyses
Coordinating inspection logistics and cross-functional preparation
Supporting teams in understanding regulatory expectations
Tracking and following up on CAPAs, commitments, improvement actions from inspections readiness
Qualifications:
Must Have
Masters degree in Science
More than 7+ years of experience in pharmaceuticals industry
Knowledge of Good manufacturing practices (cGMP).
Demonstrates skills in collaboration with CFTs & paying attention to the details to achieve the target
Nice to have:
Technical knowledge of Software like QTS/ EQMS/ PDOCS/ SDS & SAP system.
Experience in Pharmaceuticals manufacturing
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control