Supports pharmaceutical manufacturing compliance through document management, electronic form conversion, audit response preparation, change control coordination, CAPA and CCF tracking, manufacturing walkthroughs, and process improvement. The role collaborates with cross-functional teams to ensure documentation readiness and timely inspection preparation while maintaining compliance with cGMP requirements.
Use Your Power for Purpose
Our core principle and commitment towards the patients "Patients lives depends 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 responsible for Document management.
You will get a chance to be part of the projects or handle the small projects independently associated with the document management.
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:
Digital Transformation or conversion of manual FORMS into electronic system through SDS.
Maintaining the document management (Issuance & retrieval of documents).
Support during the preparation of response to audit observations,
Responsible for the CCF initiation, coordination with CFTs for impact assessment and CCF pre-approval, implementation and closure.
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.
Qualifications:
Must Have
Masters or Bachelors degree in Science.
More than 4+ 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 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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Our core principle and commitment towards the patients "Patients lives depends 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 responsible for Document management.
You will get a chance to be part of the projects or handle the small projects independently associated with the document management.
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:
Digital Transformation or conversion of manual FORMS into electronic system through SDS.
Maintaining the document management (Issuance & retrieval of documents).
Support during the preparation of response to audit observations,
Responsible for the CCF initiation, coordination with CFTs for impact assessment and CCF pre-approval, implementation and closure.
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.
Qualifications:
Must Have
Masters or Bachelors degree in Science.
More than 4+ 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 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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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