Superuser - Manufacturing Execution System
- Pfizer
- 5 - 8 years
- Visakhapatnam
- 3 years ago
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Job Description
What You Will Achieve
Your knowledge of the manufacturing domain will help in understanding of process equipment and systems, manufacturing operations, and automation control. Your primary responsibility will be to plan for and execute process and equipment operation activities during manufacturing operations. You will assist with production planning and provide / support coordinating production activities, working with the Clinical Manufacturing Team Leads and Process Engineers.
You will provide training for operational qualifications and assist the Team Lead and Process Engineer in assuring all personnel are appropriately trained for the applicable tasks. You will provide process execution and equipment operational activities in support of cGMP (current Good Manufacturing Practices) clinical and /or commercial manufacturing. You will advise management of non-conformance issues and opportunities for continuous improvement. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It- Contribute to completion of project milestones and organize own work to meet project task deadlines.
- Assess challenges to the schedule and re-directing activities as necessary to minimize impact to quality, compliance and timelines.
- Capable of detecting technical problems and assisting the appropriate colleagues for resolution.
- Perform routine production preparation tasks such as preparing production glassware and other equipment by operating industrial washers, autoclaves and dehydrogenation ovens, use calibrated scales to weigh out dry components and use graduates and flasks to measure liquids.
- Able to collect and assemble applicable, vital information for recommendations to Production Supervisors and/or Manufacturing Process Engineers to assist in troubleshooting and decision making.
- Organize daily functions and work in concert with Bioprocessing Technicians in executing operational aspects for Fermentation, Purification, and Conjugation processing in a compliant, safe and efficient manner to maintain production schedules.
- Understand scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements.
- Develop best practices and share with other teams and sites.
- Conduct all activities that are in accordance with company policies and Standard Operating Procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines, as appropriate, etc.
- Perform laboratory activities such as performing sample dilutions, pH, and conductivity readings.
- Provide input and revise Standard Operating Procedures, batch records, forms or other {Current} Good Manufacturing Practices {part of GxP} related documents to support continuous improvement efforts, investigation corrective actions etc.
- Track and follow-up on departmental commitments, investigations, change controls, change control and general compliance initiatives.
Job description:
- Preparation/revision of Electronic Batch Records (eBR) based on the approved MMR/MBR/Validated Documents.
- Supporting end users on eBR execution/usage.
- Be the first point of contact for electronic manufacturing issues.
- Escalation of Electronic manufacturing execution issues to Subject matter expert or supporting team.
- 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.
- 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 running of new upcoming SAP projects.
- Handling 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.
- Review of all related protocols.
- Initiating change controls related to documents, equipment. Ensuring their closure and implementation of changes within specific time.
- Identify deviations/exceptions and escalate to reporting manger by appropriate procedures.
- Adherence to safety procedure/GMP & GDP practices.
Job Classification
Industry: Construction, Engineering, Cement, MetalsFunctional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Post Graduation Not Required
Contact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: Automation SAP Manufacturing process Production planning Pharma Shop floor Agile GMP Troubleshooting Continuous improvement
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 he...
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