Associate Manager- Manufacturing Compliance
- Pfizer
- 7 - 12 years
- Visakhapatnam
- 3 days ago
- Email to a friend
- Report this job
Job Description
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
Work Location Assignment: On Premise
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 ControlJob Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Production, Manufacturing & EngineeringRole Category: ManagementRole: Production / Manufacturing HeadEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: SAP Manager Quality Assurance SDS Compliance Risk assessment Process improvement Inspection Monitoring Auditing Logistics
Pfizer
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a ...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in