Pfizer Aseptic Core Monitors (ACM) in Chennai, India

Primary Activity:

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.

Smoke Study:

  • 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.

SOP Revision:

Procedure revision for necessary changes related to ACM team.

Secondary Activity:

Trend Review:

  • NVPC, EM & Water trend review for state of control reference.

Training:

  • 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.

Investigation:

  • To involve and support the CAPA, failure investigations relater to clean room behavior & technique.

Implementation:

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.