Associate Manager

AssociateManager-MES

$115–165k ~AI est. United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Associate Manager - MES at Associate Manager. Skills: Manufacturing execution system, Electronic batch records, SAP, AMPS. Design and simulate AMPS recipe. Ensure recipe readiness”

Industry & Context.

Problems you'll solve

Troubleshoot; Solve problems; Identify root cause; Troubleshooting

What They're Looking For.

Must Have

Graduate or Postgraduate in Pharmaceutical Science Discipline/Engineering, 6 to 10 year of experience in manufacturing of pharmaceutical dosage forms, in the manufacturing operations, Knowledge on manufacturing of pharmaceutical dosage forms and relevant MES expertise, Experience in defending process in regulatory audits/inspection, cGMP and application of quality management systems, Good documentation practices, Technical writing and document review skills, Ability to write and revise standard operation procedures (SOP) and related manufacturing and packaging documents

Nice to Have

Preferably experiences in good understanding of manufacturing and quality systems

What You'll Do.

Design and simulate AMPS recipe

Ensure recipe readiness

Prepare/revise Electronic Batch Records

Support end users on EBR execution/usage

Troubleshoot and solve AMPS/SAP/MLM problems

Identify root cause of problems

Handle activities in Implementation projects

Handle activities in enhancements

Track documentation activity

Track change controls

Track change action items

Be the first point of contact for electronic

Escalate electronic manufacturing execution issues

Conduct trainings to executing personnel on EBR system

Handle Shop floor troubleshooting in SAP- AMPS interface

Track AMPS recipes revision

Create Bill of Material (BOM) in SAP

Create production version (PV) in SAP

Ensure readiness of BOM in SAP

Ensure readiness of PV in SAP

Handle SAP related issue

Provide shop floor support in SAP

Ensure BT ticket resolution

Participate in new upcoming MES projects

Execute new upcoming MES projects

Handle Manufacturing label management system

Design Manufacturing label management system

Ensure smooth running of Manufacturing label management system

Coordinate supporting functional departments

Ensure performed activities comply with procedures

Ensure completeness of documentation

Review all related protocols

Initiate change controls related to documents

Initiate change controls related to equipment

Ensure closure of change controls

Implement changes within specific time

Identify deviations/exceptions

Escalate deviations/exceptions to reporting manager

Adhere to safety procedure

Adhere to GMP practices

Adhere to GDP practices

Ensure compliance of operations to cGMP

Ensure compliance of operations to safety principles

Ensure compliance of operations to Pfizer integrity principles

Participate in internal audits

Participate in external audits

Prepare procedures pertaining to area

Fill/write documents pertaining to area

Submit documents to documentation cell on time

Prepare daily activity report

Attend training of all applicable procedures

Train the team on relevant procedures

Get trained on respective area of work

Provide AMPS/SAP/ MLM training to new hires

Provide refresher training to end users

How You'll Work.

Team & Collaboration

Coordinate supporting functional departments

Communication Scope

Technical writing

Process & Methodology

Implementation projects, Enhancements

Full Job Description

​​Operation ​​ * To Design and simulate AMPS (Agile manufacturing production system /FTPS) recipe towards ease of user execution and ensuring its feasibility as per site requirements. * Ensuring recipe readiness per weekly manufacturing plan. * Preparation/revision of Electronic Batch Records (EBR) based on the approved MMR/MBR/Validated Documents. * Supporting end users on EBR execution/usage. * Troubleshoot and solve AMPS/SAP/MLM problems and to get in depth/detailed understanding/identify root cause. * To proactively handle activities in Implementation projects and enhancements. * Tracking of all documentation activity i.e., SOP revision, CAPA closure, change controls, change action items and investigation * Be the first point of contact for electronic manufacturing issues. * Escalation of Electronic manufacturing execution issues to Shift Manager-MES or supporting teams. * Having thorough knowledge of Manufacturing execution system (MES). * Conducting trainings to executing personnel on EBR system. * Handling of Shop floor troubleshooting in SAP- AMPS interface. * Tracking of AMPS (Agile manufacturing production system) recipes revision as per revised/new batch records. * Creation of Bill of Material (BOM) and production version (PV) in SAP. * Ensuring readiness of Bill of Material (BOM) and production version (PV) in SAP required to create AMPS recipes. * Handling of SAP (System Application and Products) related issue and shop floor support. * SAP stock clearance, IDOC message clearance. * BT ticket follow ups and ensuring its resolution with batch release tracking. * To participate and execution of new upcoming MES projects. * Handling/Designing and to ensure smooth running of Manufacturing label management (MLM) system. * Coordinate supporting functional departments for smooth operation of production activities. * Ensure all the performed activities comply with respective procedures. * Ensure all the completeness of documentation for all performed activities.

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