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Pharma MES Quality lead

Job Description

Siemens is a market leader in the Process Automation business offering a wide range of products and solutions to our customers in various process Industry verticals.

Pharma vertical is fastest growing vertical within our Process Automation business unit. After a substantial installed base of our Automation and process control systems in last 2 decades, our customers are looking to Siemens for next level of technology solutions like MES, PAT, Simulation, digitalization etc. Specifically, to tap the growth opportunities offered by our customers in the Pharma MES area, we are augmenting our MES team with various Sales, Presales, and delivery roles.

Pharma MES Quality Lead will be responsible to manage all quality aspects in the delivery of the Pharma MES project. He will lead and will have full ownership of validation activities and milestones including documents, templates over the complete project lifecycle from design, development, testing up to deployment of the MES solution in various pharmaceutical niche in Indian market.

Role

  • Own the project delivery from quality and validation perspective
  • Define and manage the overall project validation plan
  • Define the document templates for various validation executables & deliverables (IQ, OQ, PQ, RTM)
  • Manage the execution, review, and approval of various protocols during protocol execution and deployment at site
  • Manage GxP Assessment, prepare Project Validation Plan (PVP), gap Analysis, Risk Assessment (System Level and Functional Level), Impact Assessment etc.
  • Support customers in defining larger MES infrastructure validation from similar experience in other projects

Profile (Experience, qualification) An ideal candidate should,

  • Have a bachelor’s or master’s degree in Pharmacy or bachelors’ degree in Instrumentation / Chemical Engineering from a reputed institute.
  • Have an overall 10+ years’ experience in managing quality and validation activities for Automation, SCADA, Historian, MES & related Software projects over complete project delivery lifecycle
  • Have worked for 2+ years in leading and managing quality aspects in core EBR projects execution
  • Have managed end to end complete quality and validation activities including documentation for at least one full medium to large EBR project with own responsibility up to Go live and handover
  • Have deep Knowledge of Pharma Regulatory Guideline such as 21 CFR Part 11, EU Annex 11 & relevant ICH guidelines.
  • Have overview on ISPE GAMP 5 for CSV.
  • Have exposure of facing regulatory audits such as US FDA, MHRA, TGA etc.
  • Know Pharma Documentation such as drafting of Validation Protocols & Compliance Reports etc.
  • Draft Quality Standard Operating Procedures required for daily usage of EBR in Pharma.
  • Manage Audits calendar (internal and customer) and conduct regular internal audits as per Audit calendar.
  • Be a Team player, result-oriented with proven track record of time-bound quality deliverables
  • Have good written and verbal communication skills

The role will require working under strict project timelines, collaboration, and visits to customer site over the project lifecycle.

The role will provide a deep exposure to quality, validation, and documentation in Pharma MES and related fields with potential to move to higher and senior roles in Pharma MES business.

Siemens is an equal-opportunity employer, provides a flexible and conducive work environment, learning & development opportunities and salary & benefits commensurate to experience and skills.

So come forward and be a part of the lifelong learning and fun!



Organization: Digital Industries

Company: Siemens Limited

Experience Level: Mid-level Professional

Job Type: Full-time

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