Pfizer Aseptic Core Monitors (ACM) in Chennai, India
Monitoring and Evaluation of Core Personnel Critical Activities:
To prepare the qualified core personnel schedule for evaluation tracking.
To evaluate all the qualified core personnel activities as per respective procedure.
To conduct feedback coaching session as part of Aseptic Technique Excellence (ATE) for core personnel.
To prepare the summary for core personnel activities evaluation.
Sterility Assurance Review Board (SARB):
To review and compile the data's received from CFT
To prepare the slide deck for SARB meeting.
To Conduct the SARB meeting with all core cross functional team and SLTs.
Monitor and review of Aseptic process Simulation (Media Fill) Study:
Prepare and review the intervention trend and rationale for media fill.
Pre & post approvals for Media fill protocol.
Monitoring of Aseptic Process Simulation (Media fill) from start to end for all the lines and documenting the aseptic behavior & technique observations during media fill.
Verifying the visual inspection of incubated media filled vials on 7th & 14th day.
To prepare the media fill qualified personnel list.
To review the media fill related rationale and risk assessment.
Support the media fill related failure investigation.
Review of protocol.
Monitor and ensure the execution of smoke study w.r.t aseptic processing.
Review the executed air flow patterns study videos along with the CFT.
Review of summary Report.
Procedure revision for necessary changes related to ACM team.
- NVPC, EM & Water trend review for state of control reference.
- Need base awareness training for the core personnel on clean room behavior, aseptic techniques and personal hygiene.
QRM & Rationale:
- To review the quality risk assessment and rationale for protocols related to aseptic area practices.
- To involve and support the CAPA, failure investigations relater to clean room behavior & technique.
To review and support the clean room related improvement/implementation.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.